CONTRACEFq~ION MJENSTRUAL
REGUI~ATION AND EARLY PPRGNANCY PERFORMED BY PAP~APROFESSIONALS UNDER MEDICAL SUPERVISION
TERMINATION
R i c h a r d J. S c o t t i , a o m . H a r v e y L. K a r m a n , Ph.D.
Women' s Co unity Service Center i1914 Santa Monica Blvd. Los Angeles, California 90025
ABST
CT
T h e a i m o f t h i s s t u d y is t o e v a l u a t e the feasibility of employing paraprofessionals to terminate early pregnancies using atra~matic instr~ents and minimal clinical facilities, particularly in areas where electricity or im~mediate emergency medical services are unavailable. A total of 774 consecuti~e patients whose gestational size was determined t o b e 10 w e e k s o r l e s s b y u t e r i n e p a l p a t i o n , were aspirated with Karman cannulae attached to a modified 50 c c v a c u u m s y r i n g e . The complication rate of 1.3% represented retained tissue and continuing pregnancies, which were treated by re-aspiration and one infection which responded to antibiotics.
Accepted
OCTOBER
for
publication
1976
JuLy
V O L . 14 N O . 4
19,
1976
367
CONTRACEPTION
I NTRODUCTI
ON
The efficacy and safety of flexible cannulae in terminating early pregnancies without dilation has been reported by several investigators (l-6).Most previous studies have been limited to six weeks gestation and represented a variety of clinical philosophies. T h e p r o t o c o l (7) e m p l o y e d in this study defines atraumatic termination of pregnancy specifically as a t e c h n i q u e of evacuating the uterus with small, flexible cannulae, with minimal or no cervical dilation, without, general anesthesia or the intervention of s t e e l instruments. Consequently, this paper nddresses itself to the following objectives: I.
To
validate
the
protocol
for
international
2.
To further document a have safely performed
3.
To test the efficacy of the procedure up to and the 10th week of gestation (from estimated date ovulation ) .
technique in c l i n i c
application.
which trained settings, and
paramedics including of
T h i s s t u d y is t h e c o m p i l a t i o n of 774 procedures performed by a physician and eight women paramedics under medical supervision over a four-month period. Monitored data includes blood loss, patient discomfort with or without paracervical blocks, infection, retained tissue and continuing pregnancies.
EVALUATI ON The patient is e v a l u a t e d by history and pregnancy test. Ninetythree per cent (720) o f t h e p a t i e n t s had pregnancy t e s t s of w h i c h 640-were positive (82% o f t h e t o t a l n u m b e r in t h e s t u d y ). Patients with tests were scheduled for the procedure at their request° Patients with clinical signs of pregnancy s u c h as b ~ e a s t tenderness, bloating, nausea, etc., were advised to wait for positive pregnancy tests; or if they desired menstrual.aspiration, were ~cheduled for this procedure. PROCEDUPHE The procedure is e x p l a i n e d to all patients and contraception is offered to them. After counselling and the taking of a medical history, the paraprofessional initially evaluates the uterus bimanually for size and configuratior~ Any abnormalities are noted and called to the attention o~:--the s u p e r v i s i n g physician. In evaluating patients, paramedics are instructed to inform the supervising physician of any abnormalities. In most cases, it was found that the abnormality (e.g., pelvic mass other than the gravid uterus) was not a contraindication to paramedic delivery o f t h e procedure; b u t in c e r t a i n cases (e.g., atonic and double uterus), the supervising physician performed
368
OCTOBER
1976
V O L . 14 r'qO. 4
CONTRACEPTION
the
procedure.
The short bivalve speculum is introduced into the vagina and the cervix is gently grasped with a blunt cervical stabilizer. The concave groove of the superior tip fits the circumference of the external os and serves as a guide for the insertion of the cannula. The uterus is t h e n s o u n d e d with a sterile flexible 4m_m c a n n u l a . In cases of stenotic cervices, a 2mln o r 3 ~ cannula is first inserted and pressure is a p p l i e d employing a 50 c c K a r m a n syringe. If evidence of em'~ryonic tissue is discovered, progressively larger cannulae are inserted to dilate the cervical canal slowly until the appropriate size is achieved. Each patient is informed that the use of anesthesia is at her discretion, rather than the clinician's, and approximately 50% are therefore provided the paracervical and intracervical blocks u t i l i z i n g ~ 1% Lidocaine. The Karman syringe is attached to the cannula and activated. The entire assembly is then rotated until cessation of tissue flow is noted. At this point~ rapid curette-like movements are sufficient to check the uterine wall for the characteristic grating sensatioD of an empty uterus, while still continuing negative pressure. The specimen is e x a m i n e d grossly and suspended in saline for observing the characteristic gross appearance of'placenta or chorionic villi. In cases where tissue i s s c a n t o r %There e c t o p i c pregnancy, choriocarcinoma or hydatidiform mole is Suspected, the tissue is r e f e r r e d to a pathologist for histological examination.
OBS E RVAT I ON S Of the 774 patients studied, six (0.78%) experienced symptoms of retained tissue (continued bleeding associated with cramps). Oral methergine, 0.2rag t o 0 . 4 m g by mouth for 6 total doses, was prescribed for these patients via telephone and they-were advised to return to £he clinic. Of this group, three (0.39%) required re-aspiration while the other three expelled the tissue spontaneously ( T a b l e I). Only one i00.4oF febrile,
of the six patients remained febrile (temperature above after re ~ aspiration). The one patient who remained indicating infection, received antibiotic therapy.
Two patients under 6 weeks gestation uterine size remained pregnant after resents an overall ~ rate of 0.39%.
and the
one patient procedure.
7-week This rep-
In considering the group of 134 patients with no or negative pregnancy tests, 54 p e r c e n t (72) w e r e found not to be pregnant on microscopic examination of the tissue. The adjusted sample size for those actually pregnant in this study shrinks to 702, and the rate of failure to terminate in this group is 0.42%.
OCTOBER
1976
VOL.
1NO. 4
369
CONTRACEPTION
ExceSsive bleeding (measured encountered in this series. Follow-up 92%.
in
this
series
blood
either
loss
in
over
person
or
200 by
cc)
was
telephone
not was
In reviewing demographic and historic data, most patients were between t h e a g e s o f 25 a n d 29 y e a r s (42% o f a l l p a t i e n t s ) . Forty-three per cent of the patients had no children, while 36.7%, 17% a n d 3 . 2 % h a d o n e , t w o a n d t h r e e c h i l d r e n , respectively (Table II). Interestingly, we noted two peaks in the age groups for repeated abortions, one in the 30-34 age grou p and another in t h e 4 0 + g r o u p w i t h a d e c l i n e in rate in the 35-39 age group (Table III). No reasons can be prognosticated for t~ese differences. Only 8.6% of the entire sample (N=744) had experienced previous abortions. DISCUSSION In comparing data from the present study with data available, we found the complication rate and the rate of continuing pregnancy to be encouragingly low. We have attributed this low rate to the instrumentation rather than any special technique. Other investigators (5--6), u s i n g a t r a u m a t i c techniques have had similar~complication with comparable gestational ages, whereas a review of other me~hods employing suction in conjunction with dilation and c~~~ttage with steel instruments(8), have yielded complication rate'~ the order of three times the magnitude of this study. The overall low rate in our study of 1.3% would seem to indicate that the atraumatic technique minimizes or eliminates certain complications, particularly perforation. We have found local anesthesia helpful in patients with stenotic cervices who complain of unremitting discomfort when the stabilizer is a p p l i e d or when the cannulae are introduced into the cervical canal. The use of anesthesia has thus been reserved until a trial of cannula insertion has been made, and the patient then decides whether she wants local anesthesia. We have found, in fact, that many_patients perfer not to be administered any unnecessary medication. Use of the syringe varies from operator to operator, but in this clinic, we have generally found that grasping the cannula where it joins the syringe rather that the syringe itself gives the operator better tactil~ sensitivity, approximating the sensitivity achieved heretofore by metal curettes. Sterile gauze pads are used to remove adherent tissue from the distal orifices of the cannula when flow decreases or disappears. In later pregnancies, 8 t o i0 w e e k s gestation, it has been found that dilating up to 7 or 8mm cannula and employing the largest usable cannula makes for the most efficient and rapid emptying time.
370
OCTOBER
1976
VOL.
14 N O . 4
CONTRACEPTION
Usually, t h e c e r v i x is s u f f i c i e n t l y sofh to obviate the need for steel dilators. In this clinic, they are rarely or never employed. Paracervical block and laminaria-induced dilation are preferred and utilized. I n l a r g e r u t e r i , t h o s e I0 t o 1 2 - w e e k s i z e , i t is n e c e s s a r y to use two syringes, rapidly changing and emptying while keeping the cannula in utero, since more bleeding occurs with placental separation. W---e h a v e f o u n d c h a n g i n g the syringes to be one shortcoming of these instruments, but certainly not a contraindication for their use if other vacuum sources are not available ~ In this clinic, the treatment of cramping and continued bleeding with or without fever has been re-aspiration. The repeat procedure has eventuated ~ in prompt declination of the fever within 24 h o u r s . Two of the three patients with retained tissue promptly passed the tissue with oral methergine alone. CONCLUSION 1.
Menstrual regulation can be achieved with of gestation.
2.
The procedure can be performed by trained paramedical personnel in a clinical setting under medical super~-ision without increasing the risk of complication.
3.
It would also appear from our experience that nations seeking to improve their family p lannin~ programs in areas remote from electrical sources or emergency facilities can safely provide menstrual regulation/atraumatic termination of pregnancy with simple hand-operated equipment.
OCTOBER
1976
and atraumatic termination of pregnancy minimal complications u p t o i0 w e e k s
V'OL. 14 N O . 4
371
CONTRACEPTION
TABLE SU
%
RY
OF
I
COMPLICATIONS
[
Retained Tissue No.
Mean
Weeks Gestation
of st
0-6
37
24
7
26
23
~
8
18
21
1
9
l0
19
0
I0
9
!8
0 J 0
4
Pregnancy %
No.
1.4 !
Infection
Continued
No.
%
2
1
]
0 "5
1
l
0.7
0
]
%
0.35
0
1.5
0
0.7
i
Totals:
744
0
6
I00
I
O. 78
Total
TABLE AGE
AND
PARITY
"
I
# r
z4 20--24
326
~ - ~ ~
I
3
I
O. 39
.
.
.
.
.
.
.
0
1
I
O. 13
1.3%
II DISTRIBUTION
%
#
#
0.4
3
1 2 .......
]
42
]
0.4
0
0
i0
....~ I - ~ I .~_
z-.,4
25
91
.....
......................
..
196
0 :I ~
........
12
....
0
£-
.....
0
O.l
0
................01............................... o
5
-
34
4.4
0.6
~o .......
~..~-3 ...............................7 ........................o _ 9 ~ ....
20
2.6
2-~o';~................ ...... 26 i~-i....... 32 ...........i-. . . . . . . . . . -4
...... .....
48
......... - -
Totals:744
372
0
rate--
-~ 6~7 ............".... ......8~.-7 ......
35+
I
0
r
3 93
0
0
P A R I T Y
Total #
15--19
-I
complication
AGE Yrs. Age
0
. . . .
: -
:
~
-
~
6
! 100%
4 3.33
0.5
.......
43
I~'~
]
20
284
2.6
"3 6 . 7
OCTOBER
_132
1976
17
I.
4
....2 5 17
..... 0 - 5
3.2 ............
"~VOL. 1 4 N O .
4
O
O
O
O
203 i01 41 7
25-29 30-34 35-39 40+ 774
20
326
20-24
TOTALS:
3
93
15-19
67
2
3
21
18
0
3
14
NUMBER OF PREVIOUS ABORTIONS
NUMBER OF PATIENTS
AGE
28
7.3
21.0
8.8
6.1
3.2
0
PERCENTAGE OF AGE GROUP
PREVIOUS ABORTION AND AGE DISTRIBUTION
TABLE III
8.6
0.25
0.38
2.7
2.3
2.5
0.38
0
PERCENTAGE OF ALL PATIENTS (N=774)
O
C~
+
CONTRACEPTION
REFERENCES
Karman, it. The and Gynecology
I O
O
Q
paramedic abortionist. 15 (2) - 3 7 9 - 3 8 7 , 1 9 7 2 .
Clinical
Obstetrics
K a r m a n , H. a n d P o t t s A M. Very early abortion using syringe as a v a c u u m s o u r c e . L a n c e t 1 (7759) : i 0 5 1 - i 0 5 2 , 1 9 7 2 . Margolis, A., G o l d s m i t h , S., a n d K a r m a n , H. Simplified negative pressure device for early abortion. Paper presented at the 10th Annual Meeting of Planned Parenthood Physicians, Detroit, April 1972. P i o n , R.J. , M c N a m e e , P. , R e i c h , L . A . , a n d H a l e , R . W ° Inducing the late menstrual period. Paper presented at the ~ist A n n u a l M e e t i n g o f t h e A m e r i c a n C o l l e g e of O b s t e t r i c i a n s and Gynec i-sts, B a l Harbor; F l o r i d a , M a y 1 9 - 2 4 , 1 9 7 3 .
b
6
D
O
374
Stim, E.M. Mini suction : an office abortion procedure. Paper presen£ed at t h e l l t h A n n u a l M e e t i n g of t h e ~ m e r i c a n A s s o c i a t i o n of Planned Parenthood Physicians, Houston, Texas, April 11-13, 1973. Vander Vlugt, Theresa and P itrow, P.T. w h a t is i t ? Population Report, Series
Menstrual Regulation, F. , N u m b e r 2, 1 9 7 3 .
National Women's Health Coalition. Atrau_matic Termination of PregnancyA Medical Protocol. P phlet 12-73 (Available from C, 222 E. 3 5 t h S t . , New York, NY 10016) T i e t z e , C. a n d L e w i t , S. Joint Program for the Abortion (JPSA) : early medical complication of S t u d i e s in F a m i l y P l a n n i n g 3 (6) : 9 6 - 1 1 2 , 1 9 7 2 .
OCTOBER
Study legal
1976
of abortion.
V O L . 14 NO. 4