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Early termination of pregnancy: medical induction with prostaglandins versus surgical aspiration under local anesthetic
Int. .J. Gynecol. Obstet., 1990,32: 269-274 International Federation of Gynecology and Obstetrics
269
Early termination of pregnancy: medical induction with prostaglandins versus surgical aspiration under local anesthetic N.C.W. Hill and I.Z. MacKenzie Nuffield Department of Obstetrics and Gynaecology, University of Odord, John Radcliffe Hospital, Oxford (UK) (Received February 13th, 1989) (Revised and accepted May 16th, 1989)
Abstract
Termination of pregnancy at 4-8 weeks gestation in 1085 patients using either local prostaglandin instillation (n = 820) or uterine aspiration under local anesthetic (n = 265) have been analyzed. Morbidity for both methods was similar although the incidence of side-effects (0.4%) and the transfusion rate (0%) were lower after aspiration than the respective rates of 59% and 1.3 Yo after prostaglandin treatment. Howevei the rates of genital tract trauma (0.75Yo) and uterine sepsis (1.8Yo) after aspiration were higher than the respective rates of 0.3% and 0.9% after prostaglandin treatment. The major disadvantage of prostaglandin treatment was the rate of re-admission for evacuation (8.5Yo) compared with (0.9%) after aspiration,. although patient acceptabirity for both techniques was similar. In view of the advantages, more widespread use of both methods of termination is indicated. Keywords:
Early abortion; Local anesthetic; Morbidity.
Prostaglandins;
Introduction
Termination of pregnancy during the first trimester is potentially less traumatic for the 0020-7292/90/s03.50 @ 1990 International Federation of Gynecology and Obstetrics Published and Printed in Ireland
patient both physically and psychologically than later termination. In the United Kingdom almost a third of all terminations are performed at 8 weeks gestation or under, usually by cervical dilatation and surgical evacuation of the uterus under general anesthesia [17]. Alternative approaches to this include medical termination using prostaglandins or suction aspiration under local anesthetic. With the development of the new progesterone antagonists, considerable interest has been re-awakened in the advantages of medical termination of pregnancy. We have therefore reviewed the results obtained in patients who have been treated with prostaglandins for early termination over 10 years in our unit and compared them with patients of similar gestation who had a suction aspiration termination performed under local anesthesia. Patients and methods
Between 1973 and 1983, 1085 patients were referred by family practitioners or ,local family-planning clinics for consideration of termination within the terms of the Abortion Act, 1967. Eight hundred twenty were managed with prostaglandins, and 265 had a surgical dilatation and evacuation under local anesthesia. The decision regarding which treatment method was used for individual patients Clinical and Clinical Research
270
Hill and MacKenzie
depended on the availability of prostaglandins. Data on patient characteristics, gestation and abortion method were recorded on standard record sheets; these data are illustrated in Table I. Pregnancy was diagnosed from the clinical history and examination, and was confirmed with a positive hCG result usually prior to treatment and by examination of the products of conception that were expelled or aspirated. In all cases hemoglobin, blood group and rhesus state were determined prior to termination, and anti-D was given when indicated at termination. Table II shows the regimens employed in the patients treated with prostaglandin and the number of patients treated in each group. Prostaglandins, when given by intra-uterine instillation, were dissolved in 4 ml of 5%
Table 1. Patient characteristics and gestation of 1085 women undergoing early termination of pregnancy. Prostaglandins (%) (N = 820)
Aspiration (Q) (h’ =‘265)
Mean k SD < 16 16-24 25-39 240
21.3 f 1.3 41(3.3) 440 (37.6) 604 (52.2) 70 (5.9)
21.2 * 1.0 0 (0) llS(44.5) 135 (51.0) 12 (4.5)
Parity 0 1+ Previous TOP
612 (53.0) 543 (47.0) 143 (12.4)
139 (52.4) 126 (47.6) 33 (12.5)
Marital status Single Married Previous marriage
506 (43.8) 525 (45.5) 124 (10.7)
138 (52.0) 102 (38.5) 25 (9.5)
Menstrual delay (days) Mean f SD O-l S-14 15-21 22-28 29-35 336
19.6 f 6.0 18 (3.2) 144 (17.6) 353 (43.0) 252(31.0) 32 (4.0) lO(1.2)
25.5 it 7.1 0 (0) l(2.6) 47 (17.7) 83 (31.3) 88 (33.2) 40 (15.2)
Age
Int J Gynecol Obstet 32
Drug regimens and success rates in 820 patients Table II. undergoing a medical termination of pregnancy. Treatment schedule
No. treated
No. pregnant
No. successful (Q)
Intra-uterine E* (0.1-0.5 mg/4 ml gel) 15 Me-F,* (lOO-150~g/4ml gel) Sulprostone (25-50 mg/4 ml gel)
43
38
29 (76)
493
452
388 (86)
40
40
33 (83)
34
27
15 (56)
129
116
99 (85)
46
31
35 (94)
35
34
30 (88)
820
144
Intravaginal E, (IO-30 mg/lO ml gel) 15 Me-F& l.O-1.5mg/lOml pessary) 16:16 diMe-E, (2-4 mg pessary) E, (2 mg pessary) Total
629
tylose gel which was introduced into the uterine cavity via a size 12 French-gauge Nelaton catheter passed transcervically and which was removed immediately after injection [ 151. Lipid based pessaries were used for vaginal treatment. Patients were allowed home after prostaglandin treatment and were seen and examined 1, 2 and 6 weeks later. The success of treatment was indicated by vaginal bleeding at least equivalent to a normal menstrual loss persisting for at least 4 days, and confirmed by vaginal examination and a negative post-treatment pregnancy test; uterine’ aspiration under general anesthetic was arranged for those patients in which prostaglandin treatment was unsuccessful. All vacuum aspirations were performed using size 6 or 8 Karmen catheters under paracervical block using 10 ml 1% xylocaine and adrenalin. Patients were admitted to hospital on the morning of operation and were discharged 2-4 h after termination. Routine follow-up was not arranged.
Ear& termination of pregnancy
All patients were given a questionnaire which was returned following the first subsemenstrual loss reporting any quent complications and the acceptability of the termination method.
Incomplete abortion Sixty-three (8.5%) of the patients who were treated with prostaglandins required subsequent surgical evacuation of the uterus for excessive bleeding in 37 and prolonged bleeding in 26. The need for surgical evacuation was not influenced by gestation or parity. Three (0.9%) patients who were terminated by aspiration were later re-admitted with heavy vaginal bleeding and required surgical evacuation.
Results Ninety percent of the patients treated with prostaglandin, and 99% who had a suction aspiration were subsequently found to have been pregnant at the time of the termination procedure. There were no differences in the patient characteristics for the two groups (Table I). The mean (SD) gestation for the prostaglandin group was 19.6 (6.0) days, which was significantly less than the mean (SD) gestation of 25.5 (7.1) days for the aspiration group (P Q 0.001: Student ?-test).
Side-effects Thirty-nine percent of the pregnant patients treated with prostaglandins vomited and 20% had diarrhea (Table III). The extent of the gastrointestinal side-effects was not related to gestation, analgesic requirement, or drug regimen. Oral analgesia was required by 476 (64%) following prostaglandin administration, 168 (22%) required an opiate injection, and 100 (14%) did not require any analgesia. Opiate analgesia was more frequently required by primigravidae (3 1V’o) than multigravidae (14%) (P < 0.001: x2 test). Gestation did not influence analgesic requirement. Gastrointestinal side-effects were not encountered with the aspiration procedure. A feeling of light headedness was frequently encountered immediately following injection of the paracervical block, and one patient suffered a syncopal attack. At the time of aspiration, 34% complained
Efficacy Of the 744 patients with confirmed pregnancies treated with prostaglandins, 629 (82Yo) were successfully terminated without any further treatment. Success rates for the different prostaglandin regimens are illustrated in Table II. Gestation and parity did not appear to influence the success rates, or duration of uterine bleeding with the various regimens. Only one patient undergoing aspiration was not successfully terminated, and required re-admission for aspiration under general anesthetic (see later).
Table III.
27 1
The incidence of side-effects and complications in 1085 treated patients. Aspiration (N = 265)p(o/o)
Prostaglandins
Vomiting Diarrhoea Blood transfusion Pelvic infection Genital trauma ERPC
Pregnant (N = 744) (W)
Non-pregnant (N = 76) (%)
290 (39) 149 (20) lO(1.3) 7 (0.9) 2 (0.3) 63 (8.5)
22 (30) 17 (20) 0 (0) 0 (0) 0 (0) 0 (0)
1(0.4) 0 (0) 0 (0) 6(1.8) 2 (0.75) 3 (0.9)
‘Includes two non-pregnant patients. Clinical and Clinical Research
272
Hill and MacKenzie
of a mild period type pain, and 4.5% experienced severe pain but additional analgesia was not required by any patient. Morbidity Blood loss. Ten (1.2%) patients pregnant at time of treatment with prostaglandins required a blood transfusion (Table III). Eight patients of the first 520 were transfused, compared with only two of the last 300 patients (0.6%). In all instances, transfusions were given at the time of re-admission for heavy bleeding 2-6 weeks after treatment. Gestation did not effect the transfusion requirement. None of the patients who were managed by aspiration required transfusion. Pelvic infection. Pelvic infection was suspected in 7 (0.9%) of the prostaglandin group. One patient treated with intra-uterine prostaglandins underwent a laparotomy for drainage of a pelvic abscess, the infection was considered secondary to the continued presence of an IUCD. Six (1.8%) patients undergoing aspiration were suspected of developing pelvic sepsis. Genital trauma. Genital tract trauma was not encountered in any patients managed with prostaglandins. Two (0.75%) patients managed by suction aspiration had uterine perforations. The first was a nullipara of 5 weeks gestation, and the first attempt at aspiration under local anesthetic failed because the cervix was to tight to dilate. The uterus was perforated 1 week later at a subsequent aspiration attempt under local anesthetic, a laparotomy was performed, the uterus repaired, and a complete recovery was made. The second was a multipara of 8 weeks gestation, the uterus was perforated during aspiration, which was managed conservatively without complication. A further nullipara at 7 weeks gestation had severe pain following aspiration thought to be due to uterine perforation, but at immediate laparotomy an ovarian cyst was found, the uterus being intact. Two patients, both treated with prostaglandins, required a laparotomy 10 and 14 Int J Gynecol Obstet 32
days, respectively, after treatment, diagnosis of tubal ectopic pregnancy.
with a
Non-pregnant subjects None of the non-pregnant patients had any complications after prostaglandin treatment (Table III). The incidence of side-effects was similar to the pregnant patients. Patient acceptability Of the patients treated with prostaglandins, 74% stated they would repeat the procedure if necessary on a future occasion, 20% would not and 6% were unsure. The respective figures for the patients undergoing aspiration were 82%) 9070and 9%. Discussion It is generally considered that pregnancy termination is more acceptable to the patient and results in fewer complications the earlier in pregnancy it is performed. The wish to avoid general anesthesia with its potential risks has led to the investigation of possible less traumatic, non-surgical techniques for termination of pregnancy. The use of low dose prostaglandins administered locally or aspiration using local anesthetic are two methods with the potential to achieve these goals. Both avoid general anesthesia and thus can be performed without the need for hospital admission. Both methods are acceptabIe to the majority of patients [19,20,22,23]. Our results are similar, with 74% of patients treated with prostaglandins and 82% by aspiration stating they would repeat the termination method if required. But success of a termination method depends on several factors apart from patient acceptability, and these include the efficacy, safety, and extent of side-effects, availability and long term sequelae. Our results show that aspiration under local anesthesia for early pregnancy termination is very effective and results in virtually no side-effects. The overall success rate using prostaglandins was 85% with variation
Early termination of pregnancy
between 56% and 94% according to the regimen used. These results are similar to other reports of small series using prostaglandins for early medical termination [3,8,16,21]. To achieve high rates of expulsion of the conceptus, the doses of prostaglandin required are often associated with frequent gastrointestinal side-effects. The rates of vomiting (36%) and diarrhoea (240/o) are consistent with those reported by others [4,24]. Both termination methods are associated with complications. The transfusion rate in the patients treated with prostaglandins was 1.2% which is higher than we previously reported [ 151. None of the patients who had a needed a anesthetic aspiration local transfusion. The rate of incomplete abortion (8.5Vo) was also much higher in the patients terminated with prostaglandins. Although the pelvic infection rate was slightly higher in the patients treated surgically, this is similar to 0.96Vo reported by Goldthorp [9] and 1.35Vo by Irani et al. [13]. More worrying is the uterine perforation rate of 0.75% in this group, which is similar to that reported from this department in 1030 first trimester aspiration general anesthesia terminations under (unpublished data), but higher than the 0.4% perforation rate reported in 5851 cases by Heisterberg and Khringelbach [ 121. Uterine perforation has been observed less frequently if paracervical block is used instead of general anesthesia [7, lo]. Further widespread use of both methods of termination are warranted [I]. The advantage of suction aspiration is a low rate of sideeffects, but there is a disadvantage of a higher rate of sepsis and genital tract trauma. Prostaglandins avoid a specific procedure with emotional advantages and permits anonymity; blood loss and a higher rate of evacuation and side-effects are disadvantages. However the applicability of medical terminations are limited by the gestation of the pregnancy, due to the increasing incidence of incomplete expulsion beyond 8 weeks gestation [5,11]. A of new approach is the combination prostaglandin with a progesterone antagonist
273
for early medical termination of pregnancy, which offers real hope of reducing the disadvantages of the method. Early studies using epostane, one of a series of compounds that act as progesterone biosynthesis inhibitors by competitive inhibition of the 3/3hydroxy steroid dehydrogenase activity, showed an abortion rate of 73% [2] and 82% [6]. Studies using Mifepristone (RU 486), a competitive progesterone receptor blocker, for medical termination showed less gastrointestinal side-effects than prostaglandin analogs, but only 60-85% of women aborted completely [14]. However when the drug is combined with a synthetic prostaglandin E, analog, complete abortion occurred in 95 % , of patients [18]. However to our knowledge no long term follow-up studies have been conducted with these compunds at the present time. Ref ef ewes 1 2
3
4
5
6
I 8
9 10
Baird DT, Cameron IT: Menstrual induction: surgery versus prostaglandins. Ciba Found Symp 115: 178.1985. Birgerson L, Olend A, Odlind V, Some11 C: Termination of early human pregnancy with epostane. Contraception 35: 111, 1987. Brenner PF, Marrs RP, Roy S, Mishell DR: Methods to determine success of attempts to terminate early gestation pregnancies with prostaglandin vaginal suppositories. Contraception 28: 111,1983. Bygdeman M, Martin JN, Leader A, Lunstrom V, Ramadan M, Eneroth P, Green K: Early pregnancy interruption by 15(S)15 methyl prostaglandin F2a methyl ester. Obstet Gynecol48: 221,1976. Castadot RG: Pregnancy termination techniques, risks and complications and their management. Fertil Steril45: 5, 1986. Crooij MJ, Clements J, de Nooyer CAA: First trimester abortion induced by epostane, a potent enzyme inhibitor. In: XII World Congress on Fertility and Sterility, Singapore, 26-31 October 1986, p 346. English EC: Procedures in family practice - suction curettage. J Fam Pratt 17: 1065, 1983. Foster HW, Smith M, McGruder CE, Richard F, McIntyre J: Postconception menses induction using suppositories. Obstet Gynecol65: 682, 1985. Goldthorp WQ: Ten-minute abortions. Br Med J 2: 562, 1977. Grimes DA, Schulz KF, Cates W et al: Local versus general anesthesia: which is safer for performing suction Clinical and Clinical Research
214
11
12
13
14
15
16
17 18
19
Hill and MacKenzie curettage abortions? Am J Obstet Gynecol 135: 1030, 1979. Haspels AA: Interruption of early pregnancy by an antiprogestational compound RU 486. Eur J Obstet Gynecol Reprod Biol.70: 169,198s. Heisterberg L, Kringelbach M: Early complications after induced first trimester abortion. Acta Obstet Gynecol Stand 66: 201, 1987. Irani KR, Henriques ES, Friedlander KL, Berlin LE, Swartz DP: Menstrual induction. Obstet Gynecol46: 596, 1975. Kovacs L, Sas M, Resch BA, Ugocsai G, Swahn ML, Bygdeman M, Rowe PJ: Termination of very early pregnancy by RU 486 - An antiprogestational compound. Contraception 29: 399,1984. MacKenzie IZ, Embrey MP, Davies AT, Guillebaud J: Very early abortions by prostaglandins. Lancet i: 1223, 1978. Mocsary P, Csapo AI: Work in progress - Menstrual induction with PGF,* and PGE,. Prostaglandins 10: 545, 1975. Office of Population Census and Surveys: Abortion Statistics - 1986. HMSO, London, 1987. Rodger MW, Baird DT: Induction of therapeutic abortion in early pregnancy with mifepristone in combination with prostaglandin pessary. Lancet ii: 1415, 1987. Rosen AS, Nystedt L, Bygdeman M, Lundstrom V: Acceptability of a nonsurgical method to terminate very
Znt J Gynecol Obstet 32
20
21
22
23 24
early pregnancy in comparison to vacuum aspiration. Contraception 19: 107,1979. Rosen AS, von Knorring K, Bygdeman M, Christensen NJ: Randomised comparison of prostaglandin in hospital or at home with vacuum aspiration for termination of early pregnancy. Contraception 29: 423, 1984. Smith SK, Baird DT: The use of 16-16 dimethyl trans PGE, methyl ester (ON0 802) vaginal suppositories for the termination of early pregnancy. A comparative study. Br J Obstet Gynaecol87: 712,198O. Stringer J, Anderson M, Beard RW, Fairweather DVI, Steele SJ: Very early termination of pregnancy (menstrual extraction). Br Med J 1: 7, 1975. Urquhart DR, Templeton AA: Acceptability of medical pregnancy termination. Lancet ii: 106, 1988. Wan LS, Stiber AJ, Turkel A: Termination of very early pregnancy by vaginal suppositories - (lSS)-15-methyl PGF, methyl ester. Contraception 24: 603, 1981.
Address for reprints: I.Z. MacKenzie Nuffield Department of Obstetrics and Gynaecology university of Oxford John Radcliffe Hospital Headington Oxford OX3 9DU, UK
269
Early termination of pregnancy: medical induction with prostaglandins versus surgical aspiration under local anesthetic N.C.W. Hill and I.Z. MacKenzie Nuffield Department of Obstetrics and Gynaecology, University of Odord, John Radcliffe Hospital, Oxford (UK) (Received February 13th, 1989) (Revised and accepted May 16th, 1989)
Abstract
Termination of pregnancy at 4-8 weeks gestation in 1085 patients using either local prostaglandin instillation (n = 820) or uterine aspiration under local anesthetic (n = 265) have been analyzed. Morbidity for both methods was similar although the incidence of side-effects (0.4%) and the transfusion rate (0%) were lower after aspiration than the respective rates of 59% and 1.3 Yo after prostaglandin treatment. Howevei the rates of genital tract trauma (0.75Yo) and uterine sepsis (1.8Yo) after aspiration were higher than the respective rates of 0.3% and 0.9% after prostaglandin treatment. The major disadvantage of prostaglandin treatment was the rate of re-admission for evacuation (8.5Yo) compared with (0.9%) after aspiration,. although patient acceptabirity for both techniques was similar. In view of the advantages, more widespread use of both methods of termination is indicated. Keywords:
Early abortion; Local anesthetic; Morbidity.
Prostaglandins;
Introduction
Termination of pregnancy during the first trimester is potentially less traumatic for the 0020-7292/90/s03.50 @ 1990 International Federation of Gynecology and Obstetrics Published and Printed in Ireland
patient both physically and psychologically than later termination. In the United Kingdom almost a third of all terminations are performed at 8 weeks gestation or under, usually by cervical dilatation and surgical evacuation of the uterus under general anesthesia [17]. Alternative approaches to this include medical termination using prostaglandins or suction aspiration under local anesthetic. With the development of the new progesterone antagonists, considerable interest has been re-awakened in the advantages of medical termination of pregnancy. We have therefore reviewed the results obtained in patients who have been treated with prostaglandins for early termination over 10 years in our unit and compared them with patients of similar gestation who had a suction aspiration termination performed under local anesthesia. Patients and methods
Between 1973 and 1983, 1085 patients were referred by family practitioners or ,local family-planning clinics for consideration of termination within the terms of the Abortion Act, 1967. Eight hundred twenty were managed with prostaglandins, and 265 had a surgical dilatation and evacuation under local anesthesia. The decision regarding which treatment method was used for individual patients Clinical and Clinical Research
270
Hill and MacKenzie
depended on the availability of prostaglandins. Data on patient characteristics, gestation and abortion method were recorded on standard record sheets; these data are illustrated in Table I. Pregnancy was diagnosed from the clinical history and examination, and was confirmed with a positive hCG result usually prior to treatment and by examination of the products of conception that were expelled or aspirated. In all cases hemoglobin, blood group and rhesus state were determined prior to termination, and anti-D was given when indicated at termination. Table II shows the regimens employed in the patients treated with prostaglandin and the number of patients treated in each group. Prostaglandins, when given by intra-uterine instillation, were dissolved in 4 ml of 5%
Table 1. Patient characteristics and gestation of 1085 women undergoing early termination of pregnancy. Prostaglandins (%) (N = 820)
Aspiration (Q) (h’ =‘265)
Mean k SD < 16 16-24 25-39 240
21.3 f 1.3 41(3.3) 440 (37.6) 604 (52.2) 70 (5.9)
21.2 * 1.0 0 (0) llS(44.5) 135 (51.0) 12 (4.5)
Parity 0 1+ Previous TOP
612 (53.0) 543 (47.0) 143 (12.4)
139 (52.4) 126 (47.6) 33 (12.5)
Marital status Single Married Previous marriage
506 (43.8) 525 (45.5) 124 (10.7)
138 (52.0) 102 (38.5) 25 (9.5)
Menstrual delay (days) Mean f SD O-l S-14 15-21 22-28 29-35 336
19.6 f 6.0 18 (3.2) 144 (17.6) 353 (43.0) 252(31.0) 32 (4.0) lO(1.2)
25.5 it 7.1 0 (0) l(2.6) 47 (17.7) 83 (31.3) 88 (33.2) 40 (15.2)
Age
Int J Gynecol Obstet 32
Drug regimens and success rates in 820 patients Table II. undergoing a medical termination of pregnancy. Treatment schedule
No. treated
No. pregnant
No. successful (Q)
Intra-uterine E* (0.1-0.5 mg/4 ml gel) 15 Me-F,* (lOO-150~g/4ml gel) Sulprostone (25-50 mg/4 ml gel)
43
38
29 (76)
493
452
388 (86)
40
40
33 (83)
34
27
15 (56)
129
116
99 (85)
46
31
35 (94)
35
34
30 (88)
820
144
Intravaginal E, (IO-30 mg/lO ml gel) 15 Me-F& l.O-1.5mg/lOml pessary) 16:16 diMe-E, (2-4 mg pessary) E, (2 mg pessary) Total
629
tylose gel which was introduced into the uterine cavity via a size 12 French-gauge Nelaton catheter passed transcervically and which was removed immediately after injection [ 151. Lipid based pessaries were used for vaginal treatment. Patients were allowed home after prostaglandin treatment and were seen and examined 1, 2 and 6 weeks later. The success of treatment was indicated by vaginal bleeding at least equivalent to a normal menstrual loss persisting for at least 4 days, and confirmed by vaginal examination and a negative post-treatment pregnancy test; uterine’ aspiration under general anesthetic was arranged for those patients in which prostaglandin treatment was unsuccessful. All vacuum aspirations were performed using size 6 or 8 Karmen catheters under paracervical block using 10 ml 1% xylocaine and adrenalin. Patients were admitted to hospital on the morning of operation and were discharged 2-4 h after termination. Routine follow-up was not arranged.
Ear& termination of pregnancy
All patients were given a questionnaire which was returned following the first subsemenstrual loss reporting any quent complications and the acceptability of the termination method.
Incomplete abortion Sixty-three (8.5%) of the patients who were treated with prostaglandins required subsequent surgical evacuation of the uterus for excessive bleeding in 37 and prolonged bleeding in 26. The need for surgical evacuation was not influenced by gestation or parity. Three (0.9%) patients who were terminated by aspiration were later re-admitted with heavy vaginal bleeding and required surgical evacuation.
Results Ninety percent of the patients treated with prostaglandin, and 99% who had a suction aspiration were subsequently found to have been pregnant at the time of the termination procedure. There were no differences in the patient characteristics for the two groups (Table I). The mean (SD) gestation for the prostaglandin group was 19.6 (6.0) days, which was significantly less than the mean (SD) gestation of 25.5 (7.1) days for the aspiration group (P Q 0.001: Student ?-test).
Side-effects Thirty-nine percent of the pregnant patients treated with prostaglandins vomited and 20% had diarrhea (Table III). The extent of the gastrointestinal side-effects was not related to gestation, analgesic requirement, or drug regimen. Oral analgesia was required by 476 (64%) following prostaglandin administration, 168 (22%) required an opiate injection, and 100 (14%) did not require any analgesia. Opiate analgesia was more frequently required by primigravidae (3 1V’o) than multigravidae (14%) (P < 0.001: x2 test). Gestation did not influence analgesic requirement. Gastrointestinal side-effects were not encountered with the aspiration procedure. A feeling of light headedness was frequently encountered immediately following injection of the paracervical block, and one patient suffered a syncopal attack. At the time of aspiration, 34% complained
Efficacy Of the 744 patients with confirmed pregnancies treated with prostaglandins, 629 (82Yo) were successfully terminated without any further treatment. Success rates for the different prostaglandin regimens are illustrated in Table II. Gestation and parity did not appear to influence the success rates, or duration of uterine bleeding with the various regimens. Only one patient undergoing aspiration was not successfully terminated, and required re-admission for aspiration under general anesthetic (see later).
Table III.
27 1
The incidence of side-effects and complications in 1085 treated patients. Aspiration (N = 265)p(o/o)
Prostaglandins
Vomiting Diarrhoea Blood transfusion Pelvic infection Genital trauma ERPC
Pregnant (N = 744) (W)
Non-pregnant (N = 76) (%)
290 (39) 149 (20) lO(1.3) 7 (0.9) 2 (0.3) 63 (8.5)
22 (30) 17 (20) 0 (0) 0 (0) 0 (0) 0 (0)
1(0.4) 0 (0) 0 (0) 6(1.8) 2 (0.75) 3 (0.9)
‘Includes two non-pregnant patients. Clinical and Clinical Research
272
Hill and MacKenzie
of a mild period type pain, and 4.5% experienced severe pain but additional analgesia was not required by any patient. Morbidity Blood loss. Ten (1.2%) patients pregnant at time of treatment with prostaglandins required a blood transfusion (Table III). Eight patients of the first 520 were transfused, compared with only two of the last 300 patients (0.6%). In all instances, transfusions were given at the time of re-admission for heavy bleeding 2-6 weeks after treatment. Gestation did not effect the transfusion requirement. None of the patients who were managed by aspiration required transfusion. Pelvic infection. Pelvic infection was suspected in 7 (0.9%) of the prostaglandin group. One patient treated with intra-uterine prostaglandins underwent a laparotomy for drainage of a pelvic abscess, the infection was considered secondary to the continued presence of an IUCD. Six (1.8%) patients undergoing aspiration were suspected of developing pelvic sepsis. Genital trauma. Genital tract trauma was not encountered in any patients managed with prostaglandins. Two (0.75%) patients managed by suction aspiration had uterine perforations. The first was a nullipara of 5 weeks gestation, and the first attempt at aspiration under local anesthetic failed because the cervix was to tight to dilate. The uterus was perforated 1 week later at a subsequent aspiration attempt under local anesthetic, a laparotomy was performed, the uterus repaired, and a complete recovery was made. The second was a multipara of 8 weeks gestation, the uterus was perforated during aspiration, which was managed conservatively without complication. A further nullipara at 7 weeks gestation had severe pain following aspiration thought to be due to uterine perforation, but at immediate laparotomy an ovarian cyst was found, the uterus being intact. Two patients, both treated with prostaglandins, required a laparotomy 10 and 14 Int J Gynecol Obstet 32
days, respectively, after treatment, diagnosis of tubal ectopic pregnancy.
with a
Non-pregnant subjects None of the non-pregnant patients had any complications after prostaglandin treatment (Table III). The incidence of side-effects was similar to the pregnant patients. Patient acceptability Of the patients treated with prostaglandins, 74% stated they would repeat the procedure if necessary on a future occasion, 20% would not and 6% were unsure. The respective figures for the patients undergoing aspiration were 82%) 9070and 9%. Discussion It is generally considered that pregnancy termination is more acceptable to the patient and results in fewer complications the earlier in pregnancy it is performed. The wish to avoid general anesthesia with its potential risks has led to the investigation of possible less traumatic, non-surgical techniques for termination of pregnancy. The use of low dose prostaglandins administered locally or aspiration using local anesthetic are two methods with the potential to achieve these goals. Both avoid general anesthesia and thus can be performed without the need for hospital admission. Both methods are acceptabIe to the majority of patients [19,20,22,23]. Our results are similar, with 74% of patients treated with prostaglandins and 82% by aspiration stating they would repeat the termination method if required. But success of a termination method depends on several factors apart from patient acceptability, and these include the efficacy, safety, and extent of side-effects, availability and long term sequelae. Our results show that aspiration under local anesthesia for early pregnancy termination is very effective and results in virtually no side-effects. The overall success rate using prostaglandins was 85% with variation
Early termination of pregnancy
between 56% and 94% according to the regimen used. These results are similar to other reports of small series using prostaglandins for early medical termination [3,8,16,21]. To achieve high rates of expulsion of the conceptus, the doses of prostaglandin required are often associated with frequent gastrointestinal side-effects. The rates of vomiting (36%) and diarrhoea (240/o) are consistent with those reported by others [4,24]. Both termination methods are associated with complications. The transfusion rate in the patients treated with prostaglandins was 1.2% which is higher than we previously reported [ 151. None of the patients who had a needed a anesthetic aspiration local transfusion. The rate of incomplete abortion (8.5Vo) was also much higher in the patients terminated with prostaglandins. Although the pelvic infection rate was slightly higher in the patients treated surgically, this is similar to 0.96Vo reported by Goldthorp [9] and 1.35Vo by Irani et al. [13]. More worrying is the uterine perforation rate of 0.75% in this group, which is similar to that reported from this department in 1030 first trimester aspiration general anesthesia terminations under (unpublished data), but higher than the 0.4% perforation rate reported in 5851 cases by Heisterberg and Khringelbach [ 121. Uterine perforation has been observed less frequently if paracervical block is used instead of general anesthesia [7, lo]. Further widespread use of both methods of termination are warranted [I]. The advantage of suction aspiration is a low rate of sideeffects, but there is a disadvantage of a higher rate of sepsis and genital tract trauma. Prostaglandins avoid a specific procedure with emotional advantages and permits anonymity; blood loss and a higher rate of evacuation and side-effects are disadvantages. However the applicability of medical terminations are limited by the gestation of the pregnancy, due to the increasing incidence of incomplete expulsion beyond 8 weeks gestation [5,11]. A of new approach is the combination prostaglandin with a progesterone antagonist
273
for early medical termination of pregnancy, which offers real hope of reducing the disadvantages of the method. Early studies using epostane, one of a series of compounds that act as progesterone biosynthesis inhibitors by competitive inhibition of the 3/3hydroxy steroid dehydrogenase activity, showed an abortion rate of 73% [2] and 82% [6]. Studies using Mifepristone (RU 486), a competitive progesterone receptor blocker, for medical termination showed less gastrointestinal side-effects than prostaglandin analogs, but only 60-85% of women aborted completely [14]. However when the drug is combined with a synthetic prostaglandin E, analog, complete abortion occurred in 95 % , of patients [18]. However to our knowledge no long term follow-up studies have been conducted with these compunds at the present time. Ref ef ewes 1 2
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4
5
6
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Baird DT, Cameron IT: Menstrual induction: surgery versus prostaglandins. Ciba Found Symp 115: 178.1985. Birgerson L, Olend A, Odlind V, Some11 C: Termination of early human pregnancy with epostane. Contraception 35: 111, 1987. Brenner PF, Marrs RP, Roy S, Mishell DR: Methods to determine success of attempts to terminate early gestation pregnancies with prostaglandin vaginal suppositories. Contraception 28: 111,1983. Bygdeman M, Martin JN, Leader A, Lunstrom V, Ramadan M, Eneroth P, Green K: Early pregnancy interruption by 15(S)15 methyl prostaglandin F2a methyl ester. Obstet Gynecol48: 221,1976. Castadot RG: Pregnancy termination techniques, risks and complications and their management. Fertil Steril45: 5, 1986. Crooij MJ, Clements J, de Nooyer CAA: First trimester abortion induced by epostane, a potent enzyme inhibitor. In: XII World Congress on Fertility and Sterility, Singapore, 26-31 October 1986, p 346. English EC: Procedures in family practice - suction curettage. J Fam Pratt 17: 1065, 1983. Foster HW, Smith M, McGruder CE, Richard F, McIntyre J: Postconception menses induction using suppositories. Obstet Gynecol65: 682, 1985. Goldthorp WQ: Ten-minute abortions. Br Med J 2: 562, 1977. Grimes DA, Schulz KF, Cates W et al: Local versus general anesthesia: which is safer for performing suction Clinical and Clinical Research
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12
13
14
15
16
17 18
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Hill and MacKenzie curettage abortions? Am J Obstet Gynecol 135: 1030, 1979. Haspels AA: Interruption of early pregnancy by an antiprogestational compound RU 486. Eur J Obstet Gynecol Reprod Biol.70: 169,198s. Heisterberg L, Kringelbach M: Early complications after induced first trimester abortion. Acta Obstet Gynecol Stand 66: 201, 1987. Irani KR, Henriques ES, Friedlander KL, Berlin LE, Swartz DP: Menstrual induction. Obstet Gynecol46: 596, 1975. Kovacs L, Sas M, Resch BA, Ugocsai G, Swahn ML, Bygdeman M, Rowe PJ: Termination of very early pregnancy by RU 486 - An antiprogestational compound. Contraception 29: 399,1984. MacKenzie IZ, Embrey MP, Davies AT, Guillebaud J: Very early abortions by prostaglandins. Lancet i: 1223, 1978. Mocsary P, Csapo AI: Work in progress - Menstrual induction with PGF,* and PGE,. Prostaglandins 10: 545, 1975. Office of Population Census and Surveys: Abortion Statistics - 1986. HMSO, London, 1987. Rodger MW, Baird DT: Induction of therapeutic abortion in early pregnancy with mifepristone in combination with prostaglandin pessary. Lancet ii: 1415, 1987. Rosen AS, Nystedt L, Bygdeman M, Lundstrom V: Acceptability of a nonsurgical method to terminate very
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22
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early pregnancy in comparison to vacuum aspiration. Contraception 19: 107,1979. Rosen AS, von Knorring K, Bygdeman M, Christensen NJ: Randomised comparison of prostaglandin in hospital or at home with vacuum aspiration for termination of early pregnancy. Contraception 29: 423, 1984. Smith SK, Baird DT: The use of 16-16 dimethyl trans PGE, methyl ester (ON0 802) vaginal suppositories for the termination of early pregnancy. A comparative study. Br J Obstet Gynaecol87: 712,198O. Stringer J, Anderson M, Beard RW, Fairweather DVI, Steele SJ: Very early termination of pregnancy (menstrual extraction). Br Med J 1: 7, 1975. Urquhart DR, Templeton AA: Acceptability of medical pregnancy termination. Lancet ii: 106, 1988. Wan LS, Stiber AJ, Turkel A: Termination of very early pregnancy by vaginal suppositories - (lSS)-15-methyl PGF, methyl ester. Contraception 24: 603, 1981.
Address for reprints: I.Z. MacKenzie Nuffield Department of Obstetrics and Gynaecology university of Oxford John Radcliffe Hospital Headington Oxford OX3 9DU, UK