Transabdominal cervicoisthmic cerclage for the management of repetitive abortion and premature delivery

Transabdominal cervicoisthmic cerclage for the management of repetitive abortion and premature delivery MILES

J. NOVY,

Portland,

Oregon

M.D

The indications for a transabdominal approach for cervicoisthimc cerclage (TCIC) included traumatic laceration, congenital or surgical shortening of the cervix, previously failed transvaginal cerclage, and advanced cervical effacement with intact membranes. The frequency of all cerclage procedures was 1 in 260 deliveries; one TCIC was performed for each six vaginal procedures in the period from 1966 to 1980. A O&cm Mersilene band was applied at the level of the anatomical internal OS in an avascular space between branches of the uterine artery. Prior to this operation, the 16 patients had had 55 pregnancies (excluding first-trimester abortions) and had experienced 42 fetal losses (24% salvage rate). After TCIC, 22 pregnancies in 16 patients resulted in 19 term births, two premature births with favorable outcomes, and one fetal loss (95% salvage rate: x2 = 46.5, P < 0.001). All infants were delivered by cesarean section. Postoperative morbidity and the incidence of premature labor or rupture of the membranes were low. Transabdominal cerclage is effective in selected patients with poor obstetric histories that show anatomically defective cervices, or when marked effacement has precluded high vaginal placement of the cerclage. (AM. J. OBSTET. GYNECOL. 143:44, 1982.)

CERVICAL OR ~~~~~~~isthmicinsufficiencyiswidely acknowledged to predispose women to midtrimester abortion and premature delivery. In 1955, Shirodkar’ introduced the first method for cervical cerclage with fascia lata to correct the defect during pregnancy. Since then, other procedures, such as the McDonald pursestring suture, have been introduced to prevent premature dilatation of the cervix.” Most of these operations involve a transvaginal approach to encircling the cervix with a nonabsorbable material. Although the success of these techniques is established, some women cannot be treated by transvaginal cerclage because their cervices are either extremely short, scarred, deeply lacerated, or markedly effaced. A transabdominal approach is beneficial in treating such patients. Although the procedure, as originally described by Benson and Durfee,3 in 1965, is

From the Department of Obstetrics Oregon Health Sciences University.

and Gynecology,

Presented at the Forty-eighth Annuul Meeting of the Pac$ic Co& Obstetrical and Gynecological Society, Kauai, Hawaii, September 2 7 -October 3, 1981. Reprint requests: Miles J. Navy, M.D., Ave., Beaverton, Oregon 97006. 44

505 N. W. 185th

ideally suited to women whose cervical insufficiency is complicated by a cervical deformity, it is not widely known or used. The purpose of this study was to assess the continued experience with transabdominal cervicoisthmic cerclage (TCIC) at the Oregon Health Sciences University from 1966 to 1980. The study was conducted to define the clinical criteria for selection of patients, to evaluate the benefits and risks toTCIC, and to assign this operation a place in the contemporary approach to the management of repetitive second-trimester abortion and premature delivery.

Patients and methods Sixteen patients were selected for TCIC and were followed through delivery and the puerperium in 23 pregnancies in the 15-year period from 1966 to 1980. The patients varied in age from 19 to 36 years; the mean age at the time of cerclage was 26.6 years. All were multigravid women, with a mean gravidity of 5 at the time of the operation. All patients had had earlier pregnancy losses in the second trimester, or had experienced premature delivery (in week 35 of gestation or earlier), with histories characteristic of cervical incompetence. Nonpregnant 0002-9378/82/090044+11$01.10/0~

1982 The C. V. Mosbv

Co.

Volume

Number

143 1

women with typical histories were selected for cerclage in future pregnancies by the complementary use of hysterosalpingography and the Hegar test. Diagnosing cervical or isthmic insufficiency was aided by a hysterogram that showed an abnormally widened internal OS or isthmus (greater than 8 to 10 mm, respectively) and no uterine anomaly, or a patulous cervical OS that easily admitted passage of a No. 8 or larger Hegar dilator during the luteal phase of the cycle. Preoperative hysterosalpingograms were available for 12 patients. Pregnant women with typical histories of cervical incompetence and signs of impending late abortion or premature delivery (Patients J. P., G. N., and D. D.) were selected for cerciage according to the following criteria: painless dilatation (less than 4 cm) or effacement of the cervix without rupture and bulging or prolapse of the membranes. Patient B. S. was selected for cerclage in week 15 of gestation on the basis of her history and examination alone, since it was not possible to study her before pregnancy. A coexisting anomaly of the miillerian duct (bicornuate uterus) was identified during surgical intervention. Other causes of midtrimester abortion-such as syphilis, isoimmunization, amnionitis, or maternal endocrine, systemic, or collagen-vascular disorders-were ruled out before cervical cerclage was contemplated. Cervical smears for culturing Mycoplasma organisms were obtained in four patients. One patient (T. N.) had a Ureaplasma urealyticum infection and was treated with tetracycline during the first trimester. Three other patients and their husbands were treated empirically with tetracycline. The primary clinical indications for TCIC in preference to a vaginal Shirodkar or McDonald procedure are listed in Table I. Fourteen patients had abnormally short, markedly scarred, or deeply lacerated cervices. In 12 patients, the procedure was performed electively before week 20 of gestation (mean age, 15.4 a 1.6 weeks’ gestation) and before conception in one patient. In the other three patients (J. P., G. N., and D. D.), the Mersilene band was placed in weeks 22 to 26 as therapy for progressive cervical dilatation and advanced effacement that precluded high vaginal placement of the cerclage. Histories of predisposing or contributory factors, such as obstetric or surgical trauma to the cervix, were elicited from seven patients. Three patients had had wide conization of the cervix for carcinoma in situ (CIS), and one in whom a conization had been complicated by bleeding had had a subsequent cervical amputation. Three patients said that they had been exposed to diethylstilbestrol (DES) in utero. Two patients each had had a prior abortion induced by curettage in the first or early second trimester of pregnancy. One patient had a severe granulomatous cervicitis.

Transabdominal

cervicoisthmic

cerclage

45

Fig. 1. Anatomy of the uterine cervicoisthmic junction. Hatched zone depicts arrangement of smooth muscle, most of which is in the corpus and the isthmus. The stippled area represents endometrium, and the dark zone is cervical glandular tissue. In the region of the internal OS (A) there is a junction (i.e., the isthmus) between the predominantly muscular tissue of the corpus uteri and the predominantly fibrous tissue of the cervix. There is no constant relationship between the position of the internal OS (A), the endocervical-endometrial junction (histologic internal OS)CL?),and the fibromuscular junction. C indicates the external cervical OS; D, the peritoneal reflection; E, the uterine artery and vein; and F, the “free space” for placement of the Mersilene band in the cervicouterine vasculature near the isthmus. CL is the cardinal ligament; USL, the uterosacral ligament. (Modified from Novy, M. J.: Managing reproductive failure by transabdominal isthmic cerclage, Contemp. Ob/Gyn 10:17, 1977.)

Table I. Primary indications cervicoisthmic cerclage

for transabdominal No. of patients

Condition Marked scarring after failed transvaginal cerclage Abnormally short or amputated cervix

6

Deep forniceal lacerations Marked cervical effacement, tion < 4 cm, membranes

dilataintact

Nine procedures were completed with the patient under general anesthesia, and seven, with the patient under regional anesthesia. Important clinical data on each woman, e.g., age, parity, reproductive history, gestational age at time of TCIC, and obstetric outcome, are summarized in Table II. The 16 transabdominal cerclage operations were performed by four clinical and full-time faculty members. Residents performed four of the procedures under faculty supervision. Nine patients were from my personai series. Surgical technique. The operative technique has

46

May 1, 1982

Novy

Table

Am. J. Obstet.

II. Clinical

data

on

patients

undergoing

transabdominal

cervicoisthmic

Patient

&avidity*

Parity*

M. T.

24

5

0

0

D. C.

28

.5

2

0

B. S.

25

3

0

0

M. S.

36

7

3

2

T. N.

28

3

0

0

B. Su.

28

5

1

1

M. V.

19

5

1

0

M. M.

2?

3

1

1

C. J.

24

9

4

0

M. G.

27

4

1

0

S. D.

35

11

4

4

D. K.

26

5

4

2

D. D.

33

6

5

4

c;. N.

22

1

1

J. P.

29

1

-0

B. H.

20

1

0

Hisbq Congenitally short cervix with severe scarring. One SEAB, three late abortions at 17 to 20 wk gestation, and one failed vaginal Shirodkar procedure Scarred cervix, two previous failed Shirodkar procedures. Two late abortions at 18 to 20 wk. Two premature deliveries at 28 wk with neonatal deaths Congenitally short cervix. Two late abortions at 20 to 22 wk. Failed McDonald and Shirodkar cerclage Two FTND prior to cervical conization and amputation; followed by one SEAB. two late abortions, and one premature delivery at 3 1 wk with neonatal death Extensive cervical conization, DES exposure. Two fetal losses at 20 to 22 wk. Positive Mycoplasma culture; treated with tetracycline Wide cervical conization. Three late abortions at 18 to 22 wk. One premature delivery at 28 wk with neonatal survival and cerebral palsy. Failed McDonald cerclage. Congenitally short cervix. Three late abortions at 15 to 22 wk. One premature delivery at 25 wk Severe forniceal laceration. One late abortion and one premature delivery at 33 wk with neonatal survival. Heroin addict on methadone maintenance Scarred short cervix. Two failed vaginal Shirodkar procedures. Two SEAB. two late abortions, four premature deliveries at 29 to 33 wk gestation Scarred and shortened cervix. One SEAB, two fetal losses at 22 and 24 wk Cervical conization. Scarred and lacerated cervix. Three failed vaginal cerclage procedures. Four SEAB, two late abortions, three premature deliveries with neonatal survival. Exogenous obesity Scarred cervix and granulomatous cervicitis. One FTND, three premature deliveries at 28 to 32 wk. Vaginal Shirodkar cerclage removed Bilateral forniceal lacerations after one FTND. Then four premature deliveries at 28 to 33 wk; one neonatal death. Cervix 60% effaced, 2 cm dilated, membranes intact Wide conization and partial vaginectomy. DES exposure. Premature delivery at 33 wk with neonatal survival. Cervix 90% effaced, 2 to 3 cm dilated, membranes intact Induced abortion at 12 wk with uterine perforation. Premature delivery and neonatal death at 30 wk. Cervix 90% effaced, 2 to 3 cm dilated, membranes intact Severely scarred and lacerated cervix. DES exposure. Three late abortions at 14 to 16 wk, one fetal loss at 24 wk after failed McDonald purse-string suture

TCIC = Transabdominal cervicoisthmic cerclage. SEAB = Spontaneous early DES = Diethylstilbestrol. SGA = Small for gestational age. PROM = Premature ameter. *Refers to the status at time of transabdominal cerclage.

been

described

in

peritoneal

cavity

abdominal

incision.

transversely

and

detail

elsewhere.“,

is entered The the

between

the ascending

uterine

arteries

’

by a transverse peritoneal

bladder and

is identified

isthmus at the cervicouterine space is developed carefully

Briefly,

reflection

descending laterally junction by blunt

the

or a vertical

is advanced.

is divided The

branches to

cerclage

No. of living children

Age (Yd

the

(Fig. dissection

ally angle

tissue

forceps

It is most

of the

ward

uterine

region

1);

sion.

abortion. rupture

to the uterine

connective

space

this medi-

Cynecol.

helpful

and uterine

tapered for

the

internal

a tunnel to a depth

veins

jaws

and

laterally

isthmus.

(Long

are ideal

assistant

on the uterine

of the After

arteries of the

with

traction

lar space

FTND = Full-term normal delivery, of membranes. BPD = Biparietal di-

OS and has been

place developed

right-

this

to provide

fundus

of 1 or 2 cm,

for

to the step.)

firm

up-

so as to expose

the

the

vessels in the

the surgeon

on tenavascu-

punctures

Volume

Transabdominal

143 1

Number

cervicoisthmic cerclage

47

Gestation& age at TCIC

(wk)

Delivery

Neonate

13

Cesarean section at 39 wk Repeat cesarean section at 39 wk

Male, 8 lb, living and well Male, 7 lb 8 oz, living and well

13

Cesarean section at 34 wk for PROM

Male, 3 lb 12 oz, living and well

14

Cesarean section at 39 wk Repeat cesarean section at 38 wk, and hysterectomy Cesarean section and hysterectomy at term

Female, 5 lb 8 oz, living and well Female, 5 lb, congenital defect and subnormal IQ

15

Cesarean section at 39 wk Repeat cesarean section at 38 wk

Female, 5 lb 9 oz, living and well Male, 6 lb 8 oz, living and well

15

Cesarean section at 32 wk for PROM. Bicornuate uterus

Female, 2 lb 9 oz, living; moderate BPD

16

Cesarean section Repeat cesarean Cesarean section Repeat cesarean

Male, 7 Male, 5 Female, Male, 6

14

16

at term section at 37 wk at 39 wk section at 39 wk

Female, 6 lb 4 oz, living and well

lb, living and well lb 8 oz, living and well 6 lb 15 oz, living and well lb 9 oz, living and well

16

Cesarean section at 39 wk Repeat cesarean section at 38 wk

Male, 7 lb 5 oz, living and well Female, 5 lb 14 oz, living and well

16

Cesarean section at 39 wk

Male, 8 lb 2 oz, living and well

17

Fetal death

19

Posterior colpotomy, dilatation and curettage Cesarean section at term

22

Cesarean section at 39 wk

Female, 7 lb 13 oz, living and well

25

Cesarean section at 39 wk

Female, 7 lb, living and well

26

Cesarean section at 38 wk

Male, 6 lb 16 oz, living; Hirschsprung’s

Cesarean section at term

Male, 4 lb 8 oz, SGA, living and well

Not pregnant

the posterior leaf of the broad ligament with rightangle forceps. A 15 cm segment of Mersilene ribbon (0.5 cm wide; Mersilene 5 [RS-211, Ethicon Inc.) is passed under the surgeon’s direct range of vision, because slippage of the forceps or inclusion of tissue with the ribbon could lacerate thin-walled veins. An identical procedure is completed on the contralateral side, and the Mersilene band is then passed around the zone of the isthmus and over the posterior peritoneum at the level of the insertions of the uterosacral ligaments. During the late second trimester, it is helpful to suture one end of the band to a pediatric catheter, since this

Male, 8 lb 1 oz, living and well

disease

makes it easier to pass posteriorly. The band should lie flat and fit snugly, and there should be some compression (without undue constriction) of the intervening tissue. The Mersiiene band is secured anteriorly with a single square knot, and the cut ends are fixed to the band with fine nonabsorbable sutures. The peritoneum and abdomen are then closed according to standard procedures. After the operation, the patient is monitored for evidence of developing uterine irritability, which is uncommon, unless there is marked effacement or dilatation of the cervix. Prophylactic hormones, uterine re-

48

May 1, 1982 Am. J. Obstet. Gynecol.

Novy

Table III. Obstetric after transabdominal

outcome in patients before and cervicoisthmic cerclage Before

Early abortion Late abortion Premature delivery With neonatal survival With neonatal death Term delivery Total number of pregnancies Fetal salvage rate (%)*

cerclage

After

cerclage

1 1 10 I4 3 65

2 19 23

24

95

*Excludes early abortions. Chi-square = 46.5, P < 0.001. Table IV. Effect of transabdominal cervicoisthmic cerclage on the distribution of births Gestational at deliveq

14-23 24-35 236 *Chi-square

age (wk)

28 24 3

51 44 5

1 2 19

5* 9* 86*

= 50.6, P < 0.001.

laxants, or antibiotics are not routinely administered immediately after the operation. One patient (B. S.) received progestin (17a-hydroxyprogesterone caproate) therapy throughout her first postcerclage pregnancy, but not in the second pregnancy. All patients were discharged within 3 to 7 days after TCIC, and the condition of the cervix was assessed at weekly intervals. All patients have been monitored up to the time of this writing. Of the 16 patients, six have elected to have a tubal sterilization procedure, five have had hysterectomies, and five remain voluntarily fertile. Evaluation of results. The results of transabdominal cerclage were evaluated according to the criteria introduced by Seppala and Vara? with some modification. The success rate or the postoperative fetal salvage rate was defined as the number of surviving infants expressed as a percentage of the total number of pregnancies after TCIC. Spontaneous early abortions (before week 14 of gestation) and voluntarily aborted pregnancies were excluded from consideration. The past or precerclage fetal salvage rate was similarly calculated. Differences in fetal survival rates and in the distributions of births according to gestational age were analyzed statistically by the chi-square test and were considered to be significant when P < 0.05.

Results During the 15-year period from 1966 to 1980, there were 26,730 deliveries at the University Hospital. Cervical cerclage (by transvaginal and transabdominal

routes) was performed in 103 pregnancies during the same period, a frequency of 1 per 260 deliveries; one transabdominal cerclage was performed for each six vaginal procedures (incidence of 1 TCIC per 1,672 deliveries). Fetal survival. The obstetric outcomes of 23 pregnancies in the 16 patients after TCIC are tabulated in Table III and compared with the results in the same patients before cerclage. The overall fetal survival in patients after TCIC was 95%; that before cerclage was 24% (P < 0.001). Of the 16 patients, six had two successful pregnancies and repeat cesarean section deliveries after the initial transabdominal cerclage. The effect of TCIC on the distribution of births by gestational age is shown in Table IV. Fifty-one percent of the pregnancies before cerclage ended in late abortion. Five percent of the postcerclage pregnancies did so. Likewise, 44% of the precerclage births, but only 9% of the postcerclage births, were premature (at week 35 or less of gestation). Eighty-six percent of the deliveries after TCIC, but only 5% of those before TCIC, resulted in live births at term. The differences in the distributions of late abortions, premature deliveries, and term deliveries were highly significant statistically (chi-square = .50.6, P < 0.001). Complications. The average estimated operative loss of blood was less than 150 ml. Serious operative bleeding occurred in only two patients when slippage of the right-angle forceps or inclusion of tissue with the ribbon led to laceration of thin-walled parametrial veins. In neither instance did shock develop; one patient received a blood transfusion. Hemostasis was achieved by the application of hemostatic clips and by suture ligature. Of the 16 patients, 15 experienced no postoperative complications, i.e., no hemorrhage, sepsis, fever, premature rupture of the membranes, or premature labor. Prophylactic antibiotics were not routinely given. Two of the three patients (G. N. and J. P.) who had TCIC in weeks 25 and 26, respectively, experienced transient uterine irritability, which responded promptly to the administration of /3-adrenergic agents. One fetal death in utero occurred after TCIC (Patient S. D.), as judged by the loss of fetal heart tones on the first postoperative day. Even though the patient was in no more than the seventeenth or eighteenth week of pregnancy, exposure was made difficult by obesity, a prominent sacrum, and a short transverse abdominal incision. In retrospect, fetal death was attributed to occlusion of the uterine vessels by the Mersilene band. Deliverv of a macerated fetus was accomplished by evacuation of the uterus. (If necessary, the ribbon may be cut via posterior colpotomy.) Late prenatal complications after TCIC consisted of premature labor and premature rupture of the mem-

Volume Number

Table

143 1

Transabdominal

V. Cumulative

results of surgical

treatments

for the incompetent

cervicoisthmic cerclage

49

cervical OS syndrome

Fetal sumival Before treatment

Treatment

and reference

No. of pregnancies

After

survivors (%‘o)

Transabdominal cervicoisthmic cerclage Benson and Durfee 196.57 47 Watkins 1972 9 Novy 1981 55 Transvaginal uterosacral-cardinal ligament cerclage Ritter 19781 134 Shirodkar cerclage Cousins 1980.t 1,957 McDonald purse-string suture Cousins 1980t 751

No. of pregnancies

treatment Survivors

m

Fetal salvage ratio*

11 44 24

11 2 22

82 100 95

7.45 2.27 3.96

22

54

98

4.45

222

898

8%

3.78

2%

272

74%

2.71

*Fetal salvage ratio = percentage of survivors after treatment divided by percentage of survivors before treatment. tFirst trimester abortions not uniformly excluded. SAverage results based on review of the literature branes (PROM) in two pregnancies, an incidence of about 5%. In one case (Patient D. C.), cesarean section was performed in week 34 of gestation for PROM after the patient had received isoxsuprine, aspirin, and betamethasone during 4 weeks of hospital bed rest. In another case (Patient B. Su.), TCIC was performed in week 15 of gestation on the basis of a short cervix and a tragic history (see Table II), even though a miillerian anomaly had not been ruled out. A bicornuate uterus was discovered during the operation. Postoperatively, the patient did well at home on a regimen of limited activity and oral ritodrine. Cesarean section was performed in week 32 of gestation for PROM. The infant is neurologically intact and growing normally, but has moderate bronchopulmonary dysplasia. Mode of delivery. All infants were delivered by cesarean section. A transverse incision was made in the lower uterine segment but the band was not disturbed. Three patients were febrile after cesarean section, an incidence of 14%. Only one patient (D. C.) required intensive antibiotic therapy for an associated endomyometritis. Patient B. S. required a cesarean hysterectomy after the second postcerclage delivery, because of erosion of the band through the lower uterine segment and hemorrhage. One patient (M. T.) experienced an unusual late complication. After her second postcerclage delivery, severe dysplasia of the cervix developed, and she required a cone biopsy. Conization was followed by cervical stenosis (possibly related to the cerclage), which responded to periodic dilatation. Comment The syndrome of the incompetent cervical OS has been reported to occur in 0.1% to 1.0% of all deliveries.6 The frequency of cervical cerclage procedures

in our hospital was 0.39%, which is intermediate for the reported range. It is difficult to compare the incidences of this syndrome in different obstetric populations because there is selective referral of high-risk patients to some institutions. Indeed, in the 5-year period from 1976 to 1980, when the Oregon Health Sciences University Hospital was established as a tertiary perinatal care center, the frequency of transvaginal and transabdominal cervical cerclage was twice the rate for the preceding IO-year period: the average number of deliveries increased only 40%. At the same time, the incidence of infants with very low birth weight (< 1,500 gm) increased at least fourfold. The disparity between the large increase in premature births and the incidence of cervical cerclage suggests that cervical incompetence was not being diagnosed too frequently, nor were patients being overtreated. Although one in five midtrimester abortions is due to an incompetent cervix,’ we do not know how frequently it is the cause of, or a contributory factor in, premature delivery. Possibly, cervical cerclage is underutilized on a high-risk obstetric service in relationship to the number of cases of repetitive premature labor in which cervical insufficiency may be a contributing factor. Injury to the cervix during induced abortion or childbirth is a major cause of traumatic cervical incompetence. The incidence of repeated spontaneous abortion increases proportionately with the number of therapeutic abortions.’ Wide or extensive conization of the cervix or cervical amputation can also result in a high rate of second-trimester abortion and premature delivery.g In the series reported here, induced abortion was possibly a contributory cause in only one patient. Cervical incompetence was attributed to surgical trauma (cervical conization or amputation) in five patients and

50

Novy

to forniceal lacerations in three others. In five of the other seven patients, the syndrome of cervical incompetence was associated with an abnormally short cervix (presumably on a congenital basis), and in the remaining two, no identifiable defect was found. It is difficult to assess the etiologic importance of DES in our three patients who were known to have been exposed to it in utero, since they had, also, other significant risk factors for cervical incompetence (i.e., cervical lacerations or conization). Cervical insufficiency may coexist with congenital defects of the uterine fundus,‘Oas noted in one of our patients. This diagnostic and therapeutic problem must be resolved on the merits of the individual case. Although some have indicated the value of cervical cerclage in treating the septate or bicornuate uterus, most American gynecologists prefer a metroplasty. A plea is made for prompt and liberal use of diagnostic hysterosalpingography in patients who have had even one late second-trimester abortion or premature delivery. Aside from causative factors, the primary clinical considerations in choosing TCIC rather than a vaginal Shirodkar or McDonald procedure were abnormally short, scarred, or deeply lacerated cervices in 14 patients (88%) (Tables I and II). Seven patients (44%) were known to have had failed vaginal cerclage procedures, and marked cervical and paracervical scarring was evident in six of them. In one patient, bilateral forniceal lacerations were present in association with a dilated cervix and advanced effacement in week 22; and in two other patients, dilatation (less than 4 cm) and marked cervical effacement were present in weeks 25 to 26 of gestation (Table II). Emergency TCIC was performed in the latter three patients because the cervical status precluded high placement of the Mersilene band by a vaginal approach. The fetal salvage rate after TCIC in the series reported here was 95%; the precerclage rate for the same group of patients was 24% (P < 0.001). Unlike Seppala and Vara,j we did not compare the fetal salvage rates in the treatment group with those in a control group comprised of normal multiparous patients. Since our group of patients was small and highly selected, it is unlikely that a group of randomly chosen multiparous patients (even if matched for parity) would represent a comparable population. Because TCIC was an established procedure in our hospital setting, the organization of a prospective randomized trial was not possible. When the results of this series are combined with the data of Benson and Durfee3 and Watkins,” an average fetal survival of 91% is achieved in 35 pregnancies-these data are the total published experience with this procedure (Table V). The fetal survival rates and the fetal salvage ratios with TCIC are similar to, or higher than, the survival

May 1, 1982 Am. J. Obstet. Gynecol.

rates reported with other surgical procedures for treating the incompetent cervix (Table V). The low fetal salvage ratio reported by Watkins is explained by the five term infants delivered of his two patients prior to cervical amputation and included in the precerclage statistics (Table V). The success of the transabdominal procedure is especially noteworthy in view of the severity of the clinical problems in these patients. The excellent results with TCIC may be explained in part by the specific diagnosis and management of cervical insufficiency in this group of patients. For example, Harger” reported the highest fetal salvage ratios when the McDonald or Shirodkar procedures were performed for the classic indications of cervical insufficiency. However, the inherent success of TCIC may be due to the stronger circumferential support of the isthmus and the decreased slippage of the band, which is achieved abdominally by placing the ribbon above the cardinal and uterosacral ligaments. This hypothesis is supported by the observation that 50%) of the patients in the combined series had experienced pregnancy failure after a transvaginal procedure, but did not abort after TCIC. Furthermore, Watkins’s two patients” and my one patient (Table II) whose cervices had been amputated fortify Danforth’s theory’” that the products of conception are held in utero by the connective tissue of the cervix. A successful cerclage holds a distensible cervix closed but does not prevent the ripening process. However, the resistance that is normally provided by the intact cervix can be restored by transabdominal placement of a band at the isthmus. A similar rationale was advanced by the proponents of “high” transvaginal cerclage at the level of the uterosacral and cardinal ligaments. As described by Mann and co-workers,’ the operation performed before conception involves transfixing the insertions of the cardinal and uterosacral ligaments with No. 2 nylon encased in polyethylene tubing; a 94% fetal salvage rate was achieved in a heterogeneous group of patients. A similar operation was performed between pregnancies by McDonald for his most difficult cases (when a simple purse-string suture had failed or when the cervix was lacerated); he reported a 67% success rate.14 Transabdominal ligation was necessary in four of McDonald’s patients because the cervix was inaccessible from below. There are several disadvantages to performing cerclage before conception. It will increase the pain and difficulty of spontaneous abortions that occur in the first trimester, most of which are unrelated to cervical incompetence. If patients do not become pregnant within a year or two (and a substantial percentage do not), they may attribute their infertility to the surgical procedure.7, l4 More recently, Ruiz-Velasco and associateslJ and Rit-

Volume Number

143 1

ter16 extended the application of uterosacral-cardinal ligament cerclage to pregnant patients; they have reported 72% and almost 100% success rates in 102 and 54 pregnancies, respectively. In Ritter’s series, there was a single fetal death after PROM in a twin pregnancy. His data have been included in Table V for comparison with the average results after the Shirodkar and McDonald procedures, because he also reported the fetal salvage rate before surgical therapy: however, it is doubtful that Ritter’s study group is comparable to the TCIC population since only one of his patients underwent cervical conization. Despite the efficacy of TCIC in a highly selected group of patients, some authors think that it has several disadvantages, i.e., the need for two intra-abdominal procedures, surgical intervention in a highly vascular area, and a high complication rate.l The need for two abdominal operations during pregnancy cannot be denied, but there have been few major operative complications and no serious maternal morbidity with TCIC. A loss of blood that requires transfusion is an infrequent but potential complication. Mild venous bleeding usually responds to packing or a few minutes of pressure. Otherwise, direct application of hemostatic clips is preferable to large sutures-ligatures, which could compromise the uterine blood supply. No additional febrile morbidity was incurred after cesarean section in these patients, provided that the band was left undisturbed. Patients may have more than one pregnancy with the ligature in place; six of our patients did. However, since the maternal mortality rate is five times greater after cesarean section than

Transabdominal

cervicoisthmic cerclage

51

after vaginal delivery, and since febrile morbidity occurs in nearly a third of women after cesarean section,” TCIC indirectly increases maternal morbidity and potential mortality. These considerations should be weighed against the patient‘s desire to have a mature live baby. Thus, it seems reasonable to limit TCIC to patients who have experienced failed vaginal procedures or in whom transvaginal placement of the cerclage is technically impossible or hazardous. Although, admittedly, the data are preliminary, the outcome of three term pregnancies in three patients with emergency TCICs for advanced cervical effacement has been most encouraging. Numerous obstetricians have published comments on the high incidence of chorioamnionitis and the lower fetal survival rate when cervical cerclage is applied after week 22 of gestation, and in the presence of cervical dilatation and effacement! Certainly, the prognosis is much worse if the membranes are bulging, prolapsed, or ruptured, and TCIC is contraindicated under these circumstances. However, I suggest that TCIC has a place in the treatment of the patient with advanced cervical effacement (dilatation less than 4 cm) before week 28 of gestation, when, in the judgment of the surgeon, placement of a cerclage by the vaginal approach would not be technically feasible or would be associated with a high risk of erosion through the cervix or rupture of the amniotic sac. I wish to thank Drs. Ralph Benson, Donald Montoya, John Yount, Gorham Babson, and George Marples for their assistance in collecting data and for helpful suggestions.

REFERENCES 1.

Shirodkar, V. N.: A method of operative treatment for habitual abortions in the second trimester of pregnancy, Antiseptic 54:299, 1955.

2. McDonald, I. A.: Suture of the cervix for inevitable miscarriage, J. Obstet. Gynaecol. Br. Emp. 64346, 1957. R. C., and Durfee, R.: Transabdominal cer3. Benson, vicouterine cerclage during pregnancy for the treatment of cervical incompetence, Obstet. Gynecol. 25:145, 1965. 4. Novy, M. J.: Managing reproductive failure by transab dominal isthmic cerclage, Contemp. Ob/Gyn 10: 17, 1977. 5. Seppala, M., and Vara, P.: Cervical cerclage in the treatment of incompetent cervix, Acta Obstet. Gynecol. Stand. 49:343, 1970. L.: Cervical incompetence, 1980: A time for 6. Cousins, reappraisal, Clin. Obstet. Gynecol. 23:467, 1980. 7. Mann, E. C., McLarn, W. D., and Hayt, D. B.: The physiology and clinical significance of the uterine isthmus, AM. I. OBSTET. GYNECOL. 81:209, 1961. 8. Miyamoto, J.: Background considerations on induced abortion. Int. 1. Fertil. l&5. 1973. 9. Leiman,‘G., Harrison, N. A., and Rubin, A.: Pregnancy following conization of the cervix: Complications related to cone size, AM. J. OBSTET. GYNECOL. 136:14, 1980.

10. Keetel, W. C., in discussion, of Barter, R. H., Dusbabek, J. A., Tyndal, C. M., and Erkenbeck, R. V.: Further experiences with the Shirodkar operations, AM. J. OBSTET. GYNECOL.

83:?‘92,

1963.

11. Watkins, R. A.: Transabdominal cervico-uterine suture, Aust. N. Z. J. Obstet. Gynaecol. 12:62, 1972. 12. Harger, J. H.: Comparison of success and morbidity in cervical cerclage procedures, Obstet. Gynecol. 56:543, 1980. 13. Danforth, D. N.: The distribution and functional activity of the cervical musculature, AM. J. OBSTET. GYNECOL. 68:1261,

1954.

McDonald, I. A.: Incompetence of the cervix,

Aust. N. Z. J. Obstet. Gynaecol. l&34, 1978. 15. Ruiz-Velasco, V., Matute, M. M., Brena, E., and Camacho, L. F.: Surgical correction of cervical incompetence, Int. J. Fertil. 24251, 1979. 16. Ritter, H. A.: Surgical closure of the incompetent cervix: 15 Years experience, lnt. J. Gynaecol. Obstet. 16:194, 1978. 17. Green, S. L., and Sarubbi, F. A.: Risk factors associated with post cesarean section febrile morbidity, Obstet. Gynecol. 49:686, 1977. 14.

May 1, 1982 Am. J. Obstet. Gynecol.

Novy

52

Table

I. Comparison

of study deliveries

with all other private

deliveries

(corrected

for anomalies) Perinatal

Premature

Study population Similar private population

NO.

No.

1,853 8,144

533

91

Yo

4.9 6.5

NO.

18 103

10~5

R 0.97* 1.26

*p < 0.05.

Editors’ note: This manuscript discussions were presented.

was revised

after

these

Discussion DR. CARL MARK III, Portland, Oregon. Much controversy has always surrounded the cerclage procedure. Many authors have argued that simple bed rest or placement of a pessary offers equal or greater efficacy. i* ’ Dr. Novy’s article cannot address this issue, but it does offer convincing evidence for the value of the cerclage procedure in difficult cases of undoubted cervical incompetence. Dr. Novy’s study spans the years 1966-1980, and reviews the results of an abdominal cerclage procedure devised at the University of Oregon by Drs. Benson and Durfee? There were 16 cerclage procedures and 23 pregnancies. All but one procedure were performed during pregnancy. For comparative analysis, Dr. Novy has used the only course open to him: the patient’s own past reproductive history as a control for the outcome of the pregnancy utilizing the cerclage procedure. The results speak for themselves. Twenty-eight of the 65 previous pregnancies had ended with a second-trimester loss, whereas only one pregnancy in 23 did so after cerclage. Twenty-four of the 65 (37%) previous pregnancies resulted in premature delivery, and 10 of these infants died. Only two of the 23 cerclage pregnancies (9%) ended prematurely, and both of these infants lived. The term delivery rate was 3/65 (5%) vs. 19/23 (83%). The fetal salvage rate was 24% vs. 95% (chi-square = 46.5, P < 0.001). Two cerclage procedures were performed in the late second trimester (25 and 26 weeks, respectively). The cervices were dilated 2 to 3 cm and almost completely effaced, yet abdominal cerclage afforded continuation of the pregnancy and delivery at term. In the series, operative complications were few. Serious bleeding occurred in only two patients, when the thin-walled parametrial veins were inadvertently ruptured. Only one of these patients required transfusion. Deliverv morbidity was low, as well. All patients, except the two with early trimester loss, were delivered by cesarean section. Only three of these patients had febrile morbidity, and only one required antibiotic therapy. One worrisome complication occurred in Patient B. S., in whom the cerclage eroded through the lower uterine segment and necessitated cesarean hysterectomy. One can only speculate that a too tightly drawn cerclage

effected this complication. Five of the 16 patients have already undergone hysterectomy. Although the high parity of the patients in this series may account, in part, for this rate of hysterectomy, one cannot but wonder what role a long-term foreign body, such as a cerclage, played. Our own experience with a standard vaginal approach, McDonald cerclage procedure, affirms Dr. Novy’s findings on all counts.4 We had 26 patients with 41 prior pregnancies who underwent a cerclage in the index pregnancy. In these 41 precerclage pregnancies, there was an 80.5% incidence of prematurity and a perinatal loss of 51.2%. After McDonald cerclage, the prematurity rate was 15.4%, and the rate of perinatal loss was 3.8%. These results were significant at the 0.005 level. I would agree with Dr. Novy that there is a definite, if not expanding, role for cerclage in the second and third trimesters. Twenty-two of our 61 cerclages were performed at more than 28 weeks’ gestation. As with Dr. Novy’s patients, all of ours were at advanced cervical dilatation and effacement. In this group of patients, we had a prematurity rate of 22%’ and a perinatal loss of 4.5%,. I find Dr. Novy’s comments on the probable underutilization of the cerclage procedure apropos (Table I). Our study population of 1,853 patients in whom cerclage was utilized in one of every 30 pregnancies had a lower prematurity rate and lower perinatal loss than a similar private population of patients in the Portland area in whom cerclage was used, much less frequently. These numbers were significant at the 0.05 level. The abdominal approach provides us with an effective bona fide tool in dealing with cases of extreme cervical dilatation or deformity for which no legitimate therapy existed in the past. Short-term complications appear to be few in number and manageable. The reproductive benefits are significant. In the Portland area, there is much interest in the role of prostaglandins in the process of cervical ripening and the induction of labor. Toplis and associates5 demonstrated definite and significant increases in circulating prostaglandin derivatives with the cerclage procedure. I would like to ask Dr. Novy whether he thinks the routine use of prostaglandin synthetase inhibitors might prove useful before any cerclage procedure, especially one that is performed in the late second or early third trimester.

Volume143 Number 1

REFERENCES

1. Oster, S., and Javert, C. T.: Treatment of the incompetent cervix with the Hodge pessary, Obstet. Gynecol. 48~206, 1966. 2. Vitsky, M.: Pessary treatment of the incompetent cervical OS, Obstet. Gynecol. 25:145, 1965. 3. Benson. R. C.. and Durfee. R. B.: Transabdominal cervicouterine cerclage during Pregnancy for the treatment of cervical incompetency, Obstet. Gynecol. 25: 145, 1965. 4. Mark, C., Bolton, R., Neilson, D., and Prins, R.: McDonald cerclage, an aid in preventing prematurity, Presented at the Forty-seventh Annual Meeting of the Pacific Coast Obstetrical and Gynecological Society, October, 1980. 5. Toplis, P. J.. Shepherd, J. H., Youssefmejadian, E., Jakubowicz, D., and Dewhurst, J.: Plasma prostaglandin concentrations after cerclage in early pregnancy, Br. J. Obstet. Gynaecol. 87:669, 1980.

DR. RALPHC. BENSON,Portland, Oregon. Dr. Novy has revealed how very effective transabdominal cerclage can be (95%). In 1965, Raphael Durfee and I were almost as enthusiastic, but we were pioneering. Nevertheless, despite the good news today, certain potential difficulties, including complications of major anesthesia, severe loss of blood infection, or wound dehiscence, detract from this operation. The fetus may also suffer because of the initiation of premature labor and delivery: constriction by the cerclage may critically reduce the placental circulation and cause fetal death. Dr. Novy has dealt very frankly with these and other hazards .’ Of all the risks, however, I am most concerned with the need for two laparotomies. True in a few patients, delivery can be effected from below after severance of the cerclage through the cul-de-sac, but most patients will ultimately be candidates for a cesarean section. This is a formidable prospect even for a woman who has lost numerous nonviable pregnancies, and who will do “almost anything” to secure an infant likely to survive. What then are the alternatives to transabdominal cerclage? Certainly, tocolytic drugs are not, because if uterine contractions have begun, cerclage is contraindicated. Of course, if labor develops soon after operation, the administration of ritodrine, for example, may be warranted. The real rival to our operation may be the new Ritter transvaginal cerclage. Here, the nylon suture is placed quite blindly above the cardinal ligaments to constrict the isthmus. Ruiz-Velasco, in Mexico City, using cotton umbilical tape, of all things, has added his series of 102 patients to Ritter’s 54, for a very good success rate (but not so good as Dr. Novy’s). Be this as it may, we know little, thus far, of the problems with vaginal procedure. For example, it may not be feasible unless some vaginal relaxation and descensus uteri are present. Also, downward traction on a thin, short cervix may cause the clamps to tear out and produce serious bleeding. Manipulation may trigger the Fergusson reflex and lead to the onset of labor. Infection in the lateral patent

Transabdominal

cervicoisthmic cerclage

53

cerclage tracts may become a formidable threat. All of these possibilities are obviated or minimized with the abdominal approach. However, we shall have to wait to see whether the new operation really “works.” DR. CHARLESCHAMBERS,Pomona, California. Have you noticed any decrease in the incidence of need for this procedure with the advent of colposcopy and directed biopsies and the diminution of conization of the cervix? DR. WILLIAM GRAVES, San Francisco, California. What are your postoperative instructions concerning the activity of your patients for the rest of their pregnancy? DR. SIMONHENDERSON, San Francisco, California. I would like to ask about the diethylstilbestrol(DES)-exposed daughter patient. I am seeing more and more of these in my infertility practice, and more of them seem to have incompetent cervices, so much so that I am really prompted to mention the matter to them on initial evaluation, before they actually become pregnant. When they do become pregnant, they can bear very much in mind that a cervical cerclage may be needed in their first pregnancy, before they actually have a loss. I think that this might well be an important feature, although I do not have hard data on it. I wonder whether Dr. Novy does. The incompetent cervix also seems to be more and more of a problem in those patients who have had metroplasties. I think that, sometimes, they have a combined problem. They have a septum, but they also often seem to have an incompetent cervix, as well. I think that these patients should be followed very closely in their first pregnancies. Again, it is a question of whether we can prevent some of the second-trimester losses before they happen. I would appreciate your comments on these two situations. DR. EMMETLAMB, Stanford, California. To illustrate the desirability of using a randomized clinic trial, even in highly selected groups such as this one, to control the identifiable and unidentifiable variables, I would like to report an analogous experiment in which each subject served as its own control. The group studied consisted of one hundred Lincoln pennies, each of which was flipped twice. In 25, tails came up twice. This highly selected group was then treated by immersion in the Pacific Ocean in the light of the full moon. In subsequent flips, after this treatment, there was only a 50% incidence of tails. We calculated, if I may modify the terminology in the current report, a Lincoln salvage ratio, the ratio of the proportion of heads after therapy (0.50) divided by the proportion of heads before therapy (0). This ratio is even more impressive than the fetal salvage ratio in the series collected from the literature, as reported by Dr. Novy. DR. NOVY (Closing). Despite the widely acknowledged success of cervical cerclage procedures in general, a few obstetricians remain skeptical. In order to convince them, a randomized prospective trial should

54

May 1, 1982 Am. J. Obstet. Gynecol.

Novy

be carried out. To my knowledge, no such study has yet been published in the world’s literature, and it will be difficult to organize such a study when the treatment is already widely practiced. It was not possible to do this with the group of patients reported on here because transabdominal cervicoisthmic cerclage (TCIC) was, and remains, an established mode of therapy in our hospital. Perhaps a randomized prospective trial could still be done in other hospitals where the TCIC operation is not yet routinely performed. Nevertheless, I emphasize, again, that the patients treated by TCIC represent a highly selected group with a well-defined syndrome based upon anatomic considerations and a history of multiple late fetal losses. Several patients had normal deliveries, but after a distinct traumatic event (e.g., cervical amputation), they experienced repeated fetal losses. This pattern was then reversed by TCIC. It is highly improbable that this sequence of events occurred by chance. The effect on the distribution of births by gestational age shown in Table IV provides support for the therapeutic efficacy of TCIC. With regard to Dr. Graves’ question, we do not routinely keep the patients at bed rest for 1 or 2 weeks, as was the old practice. If there is no evidence of uterine irritability, they are allowed to ambulate progressively. 1 am also impressed, as is Dr. Henderson, by the rather high incidence of second-trimester losses and premature deliveries in patients exposed to diethylstilbestrol (DES) in utero. The etiology is probably not an anatomic defect, since Haney and co-workers’ showed that the diameters of the internal OS were smaller in DES-exposed patients than in the control patients. One can speculate that the defect has a biochemical or histopathologic basis. It is too early to recommend routine prophylactic cerclage in these patients. My practice is to examine them at frequent intervals and to perform

transvaginal cerclage in the event of early cervical changes. I think that we will see a decreasing incidence of traumatic cervical incompetence as a result of the use of directed biopsies by colposcopy. The incidence of cervical incompetence is directly correlated with the volume of the cone that is removed.* In response to Dr. Mark’s query, it is well established that prostaglandins play an important role in the process of cervical ripening, and we know that the circulating levels of prostaglandin F metabolite increase after transvaginal cerclage proceduresP This suggests a possible therapeutic use for the prostaglandin synthetase inhibitors in managing premature cervical effacement. However, indomethacin and related compounds carry with their use the risk of adverse side effects on the fetal circulation (i.e., constriction of the ductus arteriosus). To date, neither the safe dose nor the duration of therapy needed to achieve a minimal risk-to-benefit ratio has been established, but it may be that short-term administration of such compounds will be beneficial wit.hout undue hazard to the fetus. In that case, I look forward to a study in which the effectiveness of cerclage procedures (particularly in the late secondtrimester) is compared with or without the adjuvant use of prostaglandin inhibitors. REFERENCES

1. Haney. A. F., Hammond, C. B., Soules, M. R., and Creasman, W. T.: Diethylstilbestrol-induced upper genital tract abnormalities, Fertil. Steril. 31:142, 1979. 2. Leiman, G., Harrison, N. A., and Rubin, A.: Pregnancy following conization of the cervix: Complications related to cone size, AM. J. OBSTET. GYNECOL. 1.36~14, 1980. 3. Bibby, J. G., Brunt, J., Mitchell, M. D., and Anderson, A. B. M.: The effect of cervical encirclage on plasma prostaglandin concentrations during early human pregnancy, Br. J. Obstet. Gynaecol. 86:19, 1979.