Second trimester medical termination of pregnancy (MTP) can be done by surgical or non-surgical methods or by various combinations of the two. Every method has advantages and disadvantages. An ideal method would be one which was safe, quick, 100% effective, inexpensive and without any immediate or late side effects. However, in the absence of such an ideal method various methods in synergistic combinations have been tried to come close to an ideal method.1-6 We have added a mechanical component to a previous medical method of extraovular ethacridine lactate instillation plus oxytocin augmentation. We achieved 99% successful results at the shortest interval without any early side effects. Keeping the costs to the bare minimum, and effectively shortening the indoor stay period, a near ideal method has been found?

A prospective study over 3 years 7 months from June 1998 to January 2002 was conducted at the Medical College Hospital, Mumbai. Permission for the study and publication of the research work was obtained from the local authorities. In the study 200, patients were selected for second trimester termination of pregnancy between 14 and 20 weeks of gestation, as calculated by menstrual dates and ultrasound biometry. One hundred patients each were in the study and control groups. Patients presenting for second trimester MTP were checked for inclusion and exclusion criteria, and eligible patients were included in the study. They were assigned to the two groups randomly.

All patients who fulfilled the requisites laid down in the Indian MTP Act of 19711 were included. Two registered medical practitioners examined all patients as required by the MTP Act. A detailed general, systemic, and local examination was performed on all patients. An obstetric ultrasound examination was performed by a consultant gynaecologist to localize the placenta prior to instillation. All patients who were detected of having a low-lying placenta on ultrasound and whose pre-instillation haemoglobin was less than 10 gm/dL were excluded. Informed consent of each patient was obtained and documented. Under full aseptic precautions, a resident medical officer (second or third year resident) performed the procedure in the operation theatre. Pre-medication comprised parenteral atropine and amoxycillin. A no. 16 Foley’s catheter was introduced for about 7-8 cm through the cervix in the extraovular space; the bulb was distended with 30 ml of normal saline and positioned at the level of the internal os. Ethacridine lactate 0.1%, 150 ml was then injected in the extraovular space and its vent was occluded. The catheter is fixed by inflating its balloon, which is placed snugly at the internal os by making traction on the catheter, and the traction is maintained by tying the catheter to a bandage around the waist of the patient. This is called as “hitching” the catheter. This bandage is the horizontal part of the T-bandage used to support vulval pads. This was made from gauze bandage. The only difference in the procedure between the control and the study group was the method of strapping the catheter after instillation of the ethacridine lactate. In the control group, the catheter was strapped to the inner aspect of the thigh with an adhesive tape or 6 hr without any traction on the balloon of the catheter. After 6 hr, the catheter was removed by deflating the balloon in both the groups if it was not expelled spontaneously. Vaginal examination was performed and if the internal os was soft, dilated by ³ 1 cm and at least 50% effaced, then a dilute oxytocin infusion at the rate of 10 mU/min was started. This was titrated until a maximum of 40 mU/min. Spontaneous abortion and expulsion of the placenta were anticipated. If the placenta failed to abort within 30 min of the foetus or the patient started bleeding prior to the 30 min interval, then immediate blunt curettage was performed. If the placenta expelled completely, and the patient was not bleeding, then a sonography was performed and completion of abortion was confirmed. All patients with an incomplete abortion underwent blunt curettage. The outcome parameters studied were instillation-abortion interval, grade of introital and pelvic pain at the time of instillation and until the catheter was in utero, failure to abort, need for other methods or re-instillation, maternal soft tissue injuries, need for blood transfusion and any other complications or maternal mortality. Each patient was asked about pain deep in the pelvis due to the hitch of the bulb on the cervix and introital discomfort as the catheter traversed anteriorly to the waistband where it was firmly strapped so as to maintain constant pressure at the internal os. The introital and pelvic pain was graded as mild, moderate, severe.

Failure to abort was reported if the abortion did not occur or was not initiated within 72 hr of the instillation. These patients were managed by intramuscular injections of 15-methyl PGF2a in the dose of 250 µg at 3 hourly intervals until abortion. Patients who failed to abort completely underwent blunt uterine curettage.

The mean gestational age in the study and control group were comparable. They were 16 and 17 weeks, respectively. In the study group, 86% aborted within 24 hr and 99% in 38 hr and 30 min. No patient in the study group had any febrile morbidity. No patient except the exploratory laparotomy required a blood transfusion. Twenty patients, all nulliparas, had Grade 1 discomfort during hitching the Foley’s bulb. However, none of them requested removal of the traction for relief. None of them subsequently had any further pelvic pain or discomfort. No patient had introital discomfort. No patient required analgesics or sedatives.

Table 2 summarizes the outcome

Minimum instillation-abortion interval was 7 hr. The Maximum instillation-abortion interval was 38 hr and 30 min. Mean instillation abortion (I-A) interval was 17.35 hr, median was 15.3 hr, mode was 12 hr. Z test for mean values was 14.131 and it was significant (if value < 1.96, not significant).

One patient, para 1, living 1, MTP 1, had a right lateral wall rupture of the uterus and expulsion of the foetus in the broad ligament (Table 3).

*Rupture of the right lateral uterine wall and foetus in the right broad ligament.

Exploratory laparotomy with suturing of the tear was done and 2 units of blood transfused. Nine control patients failed to abort within 72 hr of the instillation. These patients aborted after repeated intramuscular doses of 15-methyl PFG2a at 3-hourly intervals.

In our study, 20 nulliparas complained of mild discomfort while the catheter was hitched at the internal os during the procedure. However, subsequently, they felt neither pain nor any pelvic or introital discomfort while the Foley’s catheter remained strapped to the waistband. No patient was given any analgesic or sedative in the pre- or post-instillation period. In all patients, after 6 hr when the bulb was deflated and removed, the internal os was found to have dilated to 1 cm. In 60% of the cases, the cervix was short, soft and partly effaced. In these cases, oxytocin drip as mentioned earlier, was started immediately after removal of the catheter. In the remaining patients vaginal examination was repeated after 6 hr or earlier if they started having uterine activity and depending on the effacement, an oxytocin drip was started. There was no evidence of cervical tears due to the Foley’s bulb hitch at the internal os.

The patient who experienced rupture of uterine wall showed that her cervix remained tubular and firm, though the internal os admitted one finger. Without waiting for effacement of the cervix an oxytocin drip was started after 24 hr of instillation. This drip was titrated to 40 mU/min over 6 hr and then maintained. She started getting uterine contractions after 6 hr of starting the drip but cervix failed to dilate. After 42 hr of instillation or after 18 hr of the oxytocin drip the patient showed signs suggestive of a ruptured uterus. She required exploratory laparotomy, evacuation of the foetus and the placenta from the right broad ligament and suturing of the right lateral wall of the uterus from the level of the internal os to the insertion of the right round ligament. The patient required 2 units of blood for transfusion. She had an uneventful postoperative period, and was discharged on day 8 after suture removal.

There were no cases with suspected or manifest post-abortal sepsis in the study group. No patient developed febrile morbidity (defined as a temperature ³ 38oC on at least two consecutive days). However, two patients in the control group had a febrile morbidity after 48 hr of the abortion. Both of them responded to cephalzolin and metronidazole injections. One patient had aborted in 52 hr and the other had aborted after PGF2a injections. Only 8% of patients aborted completely which was confirmed on sonography. The others required a blunt check curettage. No patient had excessive haemorrhage requiring blood transfusion.

Table 4 shows that the induction-abortion interval is reduced in the study group across all gestational ages from 14 to 20 weeks of gestation. Table 6 shows the influence of parity on the induction-abortion interval. The nulliparas and the multiparas both had a shorter I-A interval in the study group as compared to those in the control group. The response of nulliparas was better or similar to that of the multiparas, probably because hitching the Foley’s bulb improved the effacement of the cervix; Table 5.

The results of the injection-abortion interval after intramuscular PGF2a in 9 patients who failed to abort in the control group are seen in Table 6

All 9 patients aborted after prostaglandin injections, and all had gastrointestinal disturbances.

Maximum injections required were 7 and minimum were 4.

None of the other patients had any gastrointestinal disturbances. As shown in Table 3 only 26% patients in the control group aborted within 24 hr and could be discharged after 24 hr.

Another 50% went home on day 3. Fourteen per cent patients could go home only after 72 hr (day 4) and the remaining 10% patients went home after a week of their admission. In the study group as 86% patients aborted in 24 hr they could be discharged after 24 hr, and the remaining 14% went home in the next 24 hr as the maximum I-A interval was 38 hr and 30 min.

Extraovular instillation of ethacridine lactate has been used for more than 40 years in Japan2 and more recently3 with favourable results. Table 2 depicts instillation-abortion interval in the study and the control group. In the study group, 86% women, 61% multiparas and 25% primigravidas aborted within 24 hr whereas in the control group 9 patients failed to abort.

Z-test was performed on Mean IA values of both the Groups. Olund and Larson,4 reported an I-A interval of 30 hrs even when oxytocin was used as an augmenting agent; 30% of their patients also reported having gastrointestinal side effects. Bharti and Vohra,5 reported that 44% aborted within 24 hr, 28% within 48 hrs and 22% within 72 hrs; 94% patients aborted within 72 hrs, 6% required re-instillation after 72 hrs who subsequently aborted. In our series, 86% aborted within 24 hrs and the rest in the next 15 hrs. We infer from this that the mechanical dilatation caused by the Foley’s hitch on the internal os acted as a pre-abortion cervical ripener, thus reducing the total duration of the procedure. As this was gradual cervical dilatation, there were no cervical soft tissue injuries. Seventy-two per cent patients aborted within 18 hrs of instillation of the ethacridine lactate and 86% patients aborted within 24 hrs. No patient required re-instillation. No patient required adjuvant drugs like PGF2a. Table 7 shows the reduced median I-A interval in our series of only 15.3 hrs as against 30 hrs or more in the other series.

The reduced induction-abortion interval were seen across all gestational ages from 14 to 20 weeks though women aborted earlier when the pregnancy was advanced, Table 4.

Himmelman6 reported an incidence of 1.5% of patients having haemorrhage, though none required blood transfusion; 9% had pelvic infection, 1% had manifest infection, and 8% had suspected infection. Filshie7 reported a 4% infection rate. A remarkable reduction in the hospital stay, savings in terms of cost and time were seen in the study group. Reduction in the I-A interval is a much desired outcome for second trimester abortion. Slow dilatation of the cervix due to the Foley’s hitch, unlike rapid dilatation should reduce the risk of cervical incompetence in subsequent pregnancies. A summary of complications in different series is depicted in Table 8.