Induction-abortion Interval Research Articles

STUDIES ON 15(S)15 METHYL PGF2α BY INTRAMUSCULAR ROUTE FOR SECOND TRIMESTER ABORTION (TWO HOURLY SCHEDULE)

A multicentre study was undertaken to study intramuscular 15(S)15 methyl PGF2α (Prostin 15M, Upjohn) for induction of second trimester abortion. The patients were premedicated with Imodium and Perinorm to control the gastrointestinal side effects. The dose of Prostin 15M was 250 µg every two hours and the progress of the abortion was assessed before each injection. If there was no progress at the end of 10 injections the case was classified as a failure. Ninety-seven patients were recruited for the study, 39 were primigravidae and 58 multigravidae. Twenty-four out of 39 primigravidae and 52 out of 58 multigravidae aborted with the treatment. The mean induction abortion interval was 17.8 hours in the primigravidae and 14.5 hours in the multigravidae patients. The mean number of episodes of vomiting was 2.9 and diarrhoea 4.2 per patient per trial. The primigravidae had slightly higher incidence of gastrointestinal side effects. The overall incidence of incomplete abortion was 17.1%.

Second Trimester Abortion by Rivanol with or Without Cervical Dilatators: A randomized comparison

Fifty women undergoing second trimester legal abortion were randomly assigned to one of three groups: 1. given Rivanol and left with balloon catheter in the cervical canal with addition of oxytocin infusion. 2. same treatment as above but catheter removed and replaced by a Lamicel cervical dilatator, 5 mm in diameter; 3. as group 2, but with a 6 mm Laminaria tent inserted. Induction-abortion interval and need for analgesics were recorded, as well as possible side effects and complications. No statistical differences were found between the three groups for any of the parameters. We have thus not been able to show any advantages of using Laminaria or Lamicel osmotic cervix dilatators in second trimester abortions.

Randomized trial of intracervical prostaglandin E 2 gel and intraamniotic prostaglandin F 2α for induction of second trimester abortion

For the purpose of reducing the side effects and complication rate when inducing second trimester abortion, intracervically administered PGE 2 gel was tested for the first time and compared with a single intraamniotic instillation of PGF 2α by a randomized allocation of 41 consecutive patients in the 13th to 24th week of gestation. In both groups the treatment was supplemented with oxytocin 5–6 hours after starting the induction. The methods proved of equal value as regards the abortion success rate and the induction-abortion interval, whereas the incidence of gastrointestinal side effects on intracervical application of PGE 2 gel was only half as high and the occurrence of diarrhea significantly lower (p < 0.05) with this non-invasive method than with intraamniotic PGF 2α. Intracervical PGE 2 gel also possessed other advantages, being int. al. more acceptable by the patients and technically easier to administer.

Termination of second trimester pregnancy by intramuscular injection of 16-phenoxy-ω-17,18,19,20-tetranor-PGE 2 methyl sulphonylamide

Two doses of the prostaglandin analogue 16-phenoxy-ω-17,18,19,20-tetranor-PGE 2 methyl sulphonylamide were compared in a randomized multicentre trial in 6 centres for the termination of second trimester pregnancy. A total of 295 patients were treated with either 0.5 mg or 1.0 mg given by intramuscular injection every 4 h or 8 h, respectively. The 1-mg dose was more effective in inducing an abortion than the lower dose but the difference was not statistically significant. Eighty-four per cent of the patients aborted within 30 h from the onset of treatment. The induction-abortion interval was approximately 15 h in both groups. The incidence of incomplete abortion, heavy blood loss and blood transfusion was similar for both treatments. Cervical lacerations occurred in 1.3% of patients given the smaller dose and 2.1% of the larger dose. In one patient belonging to the latter group an anterior rupture of the lower uterine segment was diagnosed necessitating hysterectomy. Fifty per cent of the patients had no vomiting and 90% no diarrhea. The frequency of gastrointestinal side effects was slightly higher with the 1-mg dose. The major advantages of this treatment are the simplicity of administration and the low frequency of gastrointestinal side effects in comparison with prostaglandin F analogues.

Midtrimester abortion with intravenous administration of 15 methyl prostaglandin F 2α

In a trial of 71 women, 15(S) 15 methyl PGF 2α was administered intravenously at the dose level of 1 μg/min for termination of pregnancy of between 11 weeks and 20 weeks of gestation. Sixty-one subjects (85.9%) aborted within 30 h of administration of the drug. The mean induction abortion interval was 15.65 h. The mean number of episodes of vomiting and diarrhea was 0.9 and 0.6, respectively. The effectiveness of the method is comparable to that of intramuscular method of administration, but the side effects are much less in comparison.

Combined extra-amniotic prostaglandin E2and oxytocin as a method of mid-trimester abortion

SummaryA simplified method of mid-trimester abortion using extra-amniotic prostaglandin E2 and oxytocin administered by a Sage pump, with ampicillin, is described. The results of 52 consecutive cases have been analysed and show a mean induction—abortion interval of 12·6 hours for the combined administration of prostaglandin E2, and intravenous oxytocin, which compares; favourably with other more complicated regimensUterine curettage was employed in all cases to ensure complete emptying of the uterus This was carried out as a ward procedure and ensured inspection of the cervix before the patient was discharged A symptomless cervical laceration was noted in one patient.

Plasma levels of 15(S)15-methyl-PGF 2α-methyl ester following vaginal administration for induction of abortion in women

A single suppository containing 3.0 mg 15(S)15-methyl-PGF 2α-methyl ester was administered vaginally in women to terminate mid-trimester pregnancy. Plasma levels of the drug (both methyl ester and free acid forms) were measured at different time intervals using deuterated carriers and gas chromatography-mass-spectrometry. 15(S)15-methyl-PGF 2α (sum of methyl ester + free acid) was found to have a mean value of 1166 pg/ml plasma at 3 hrs after administration of the suppository. The mean levels were subsequently found to be maintained in the range of 1000 pg/ml. Preliminary studies showed that unlike the successfully aborted women in those who did not abort within 30 hrs with this suppository, the plasma levels of the drug were not maintained for a sufficiently long time. The episodes of side effects, body surface area and the induction-abortion interval in relation to the plasma levels are discussed.

Indian experience with a single long-acting vaginal suppository for the termination of pregnancies

The Indian Council of Medical Research conducted a multicentric trial with a single vaginal suppository containing 3 mg 15-Me-PGF 2α for terminating pregnancies. Success rate in the 290 women investigated was 79.2 per cent at 30 hours observation. The mean induction-abortion interval was 14.7 hours and the incidence of complete abortions was 58.3 per cent. Vomiting and diarrhoea were the most common side-effects noted. Vomiting was experienced by 72.3 per cent women and diarrhoea by 76.8 per cent. Although the vaginal route for administering 15-Me-PGF 2α is simple and the induction-abortion interval short, it is suggested that the combination of a vaginal suppository and prostaglandins intra-muscularly may lead to higher percentage of complete abortions.

The effect of indomethacin on the instillation‐abortion interval in rivanol‐induced mid‐trimester abortion

During 1975-1977, 20 women undergoing mid-trimester (mean 16.1 weeks) abortions induced by Rivanol were treated with oral doses of 50 mg indomethacin every 6 hours starting immediately prior to the instillation of Rivanol. A group of 55 women undergoing Rivanol abortions (mean gestational age 15.6 weeks) during the same period acted as a control. It was found that administration of indomethacin, a strong inhibitor of prostaglandin synthesis, prolonged the induction-abortion interval significantly from a mean of 32.3 hours in the control group to a mean of 46.9 hours in the indomethacin group. This result adds support to the theory that the mechanism by which Rivanol induces abortion involves the stimulation of the endogenous production of prostaglandins.

Use of intra- and extra-amniotic prostaglandins for the termination of pregnancies — Report of multicentric trial in India

The Indian Council of Medical Research initiated a, multicentric trial with prostaglandins in 1976 to assess the safety and efficacy of their use in midtrimester abortions, PGF 2αand 15-Me-PGF 2α were compared using the intra-amniotic (I.A.) route, 15-Me-PGF 2α was also evaluated by extra-amniotic (E.A.) route. With intra-amniotic instillation, success rate was 88.1 per cent with PGF 2α and 93.0 per cent with 15-Me-PGF 2α within 48 hours and by the extra-amniotic route it was 78.1 per cent within 36 hours. The mean induction-abortion interval was 19 hours with I.A. and 14.8 hours with E.A. Abortions were complete in 48.8 per cent of the women following I.A. PGF 2α, 56.0 per cent following I.A. 15-Me-PGF 2αand only 23.0 per cent following E.A. administration. Vomiting and diarrhoea were the most commonly reported side effects. Cervical injuries were 4.7 per cent with I.A. PGF 2α, 1.4 per cent with I.A. 15-Me-PGF 2α and only 0.6 per cent with E.A. route.

Induction of second trimester abortion: Comparison between vaginal 15-methyl-PGF 2α methyl ester and intra-amniotic PGF 2α

The efficiency and acceptability of a single-dose, long-acting vaginal suppository containing 3.0 mg of 15-methyl PGF 2α methyl ester was compared with intra-amniotic administration of 50 mg of PGF 2α in 100 patients with a second trimester pregnancy termination. Within 24 hours, 78 per cent of the patients in the vaginal group and 92 per cent in the intra-amniotic group had aborted. The mean induction-abortion interval was 17.9 hours in the vaginal group and 15.8 hours in the intra-amniotic group. Gastrointestinal side-effects were more frequent, but the procedure was less painful, with vaginal 15-methyl PGF 2α methyl ester than with intra-amniotic PGF 2α. The vaginal route is technically simple for adaptation to large-scale use, but the high frequency of gastrointestinal side-effects still limits the acceptability of 15-methyl PGF 2α methyl ester in vaginal administration.

INDUCTION OF LABOUR WITH PROSTAGLANDIN E2 GEL IN CASES OF INTRAUTERINE FETAL DEATH

In established intrauterine fetal death, 20 patients were treated with prostaglandin E2 gel administered extraamniotically. The results were compared with those of another group of 20 patients who had received combined treatment. In this group, one or more of the following agents had been administered :- i.v. oxytocin, 20% NaCl solution or Premarin instilled intraamniotically, introduction of a balloon catheter or Rivanol administered extraamniotically. Average induction-abortion interval for the PG group was about 12 hours while for the second group it was about 30 hours. The side effects observed were slight in both groups. The results show that administration of PG-gel can be used with advantage in fetal demise because of the relatively short induction-abortion intervals obtained, the insignificant side effects and the low dose of PG required.

VAGINAL PROSTAGLANDIN E2 IN THE MANAGEMENT OF FETAL INTRAUTERINE DEATH

The results of a multicentre clinical trial of prostaglandin E2 (PGE2) administered by the vaginal route in the management of intrauterine fetal death and missed abortion showed an overall efficacy of 97 per cent. The mean induction-abortion interval was 10.7 hours with a mean total dose of 60.4 mg of PGE2. Side effects were tolerated well and there was no evidence of significant alterations in hepatic or renal function.

Evaluation of a single dose schedule of 15(S)15 methyl PGF 2 alpha methyl ester suppository for the termination of 10–14 weeks of pregnancy

The abortifacient efficacy of a single vaginal suppository containing 3 mg of 15(S)15 methyl PGF 2 alpha methyl ester in 10 to 14 weeks of pregnancy was evaluated in 58 women. The success rate was 72.4% in the trial period of 30 hours. The mean induction-abortion interval was 17.9 hours in the successful cases. In multigravidas the success rate was found to be comparatively higher with shorter induction-abortion interval in comparison to primigravidas. The episodes of vomiting and diarrhea per patient were 0.8 and 1.4, respectively. The induction-pain interval was significantly higher in failed cases. All the failed cases were aborted vaginally with the supplementary administration of 15(S)15 methyl PGF 2 alpha.

Induction of labour with prostaglandin E 2 gel in cases of intrauterine fetal death

In established intrauterine fetal death, 20 patients were treated with prostaglandin E 2 gel administered extraamniotically. The results were compared with those of another group of 20 patients who had received combined treatment. In this group, one or more of the following agents had been administered: - i.v. oxytocin, 20% NaCl solution or Premarin instilled intraamniotically, introduction of a balloon catheter or Rivanol administered extraamniotically. Average induction-abortion interval for the PG group was about 12 hours while for the second group it was about 30 hours. The side effects observed were slight in both groups. The results show that administration of PG-gel can be used with advantage in fetal demise because of the relatively short induction-abortion intervals obtained, the insignificant side effects and the low dose of PG required.

Clinical and hormonal studies with 3 mg 15(S) 15-methyl-PGF 2a methyl ester long-acting single vaginal suppository

Intra-vaginal administration of a single 3.0 mg 15-methyl-PGF 2a methyl ester suppository was evaluated for pregnancy termination in 96 women having a mean gestation of 17.9 ±1.8 weeks. The trial was considered successful if complete or incomplete abortion occurred within 30 hours after the insertion of the suppository. The success rate within 30 hours was 51.7 percent and the mean induction-abortion interval in successful cases was 17.0 ± 6.9 hours. The success rate for multiparous was 62.7 percent as against the 36.8 percent for nulliparous. The mean episodes of diarrhoea and vomiting per patient were 2.8 and 1.9, respectively. The induction-pain interval in the successful cases was 2.27 hours as against 3.61 hours in failed cases. The difference was statistically significant P∠ 0.05. The drug administration elicited a rapid and sustained decline in the circulating levels of estradiol-17B, progesterone and placental lactogen in the successful cases. The change in these hormones was slow and inconsistent in cases which did not abort during the trial period of 30 hours. Failed cases were managed by supplementary 15-methyl-PCF 2a administered intra-amniotically and/or intramuscularly. They all aborted within a further mean period of 18 hours. The intra-vaginal insertion of a single suppository for the termination of second trimester pregnancy thus would be an attractive approach provided some improvements to achieve a better success rate with lesser gastrointestinal side effects can be made.

Mid-trimester abortion induced by intravaginal administration of prostaglandin F 2α-methylester suppositories

Mid-trimester abortion was successfully induced in 28 of 31 patients by administration of vaginal prostaglandin F 2α-methylester. A suppository containing 1.5 mg was given every three hours. Two of the patients who failed to abort needed a D & C after 24 and 30 hours. In the third patient “ballooning” of the lower uterine segment was observed. The mean induction-abortion interval was 15.6 ± 1.1 hours. The mean dose was 8.5 mg. The patients were mostly primiparous women between 13 and 32 years with a mean age of 19.5 years. In 8 patients abortion was incomplete and surgical intervention was required to remove the placenta. Only one patient had an estimated blood loss exceeding 250 ml (approx. 1000 ml) which required transfusion. The most frequently encountered side effects were sleepiness and gastrointestinal disturbances (despite premedication with anti-emetic and anti-diarrheal agents). Postabortion lactorrhea is a seldom mentioned but real side effect of Pg-induced abortion. In general the side effects were minimal and never required termination of therapy. Midtrimester abortion with intravaginal PgF 2α-methylester suppositories appears to offer a valid alternative to the presently available techniques.

Vaginal administration of 15(s)15-methyl prostaglandin F 2α methyl ester for induction of mid-trimester abortion

A clinical trial with 15(S)15-methyl prostaglandin F 2α methyl ester for termination of second trimester abortion is described. The compound was administered vaginally by means of 1.5-mg suppositories and this dose was repeated every three hours until the patient aborted or up to 24 hours. Twenty-nine patients were studied. Lomotil tablets were administered to reduce gastro-intestinal side effects. A success rate of 96.5% was obtained. Approximately 76% of the patients aborted within 18 hours. The mean induction-abortion interval was 12.5 hours, with no significant difference between primigravidae and multigravidae. The abortion was complete in 17.9%. The incidence of vomiting and diarrhoea was high, 3.6 and 3.9 episodes per patient, respectively. Further studies with a lower dose of 15(S)15-methyl prostaglandin methyl ester vaginal suppositories may prove to be just as effective but with a more acceptable frequency of gastro-intestinal side effects.

Use of prostaglandin for induction of second trimester abortions in high risk pregnancy

Experience with the use of prostaglandin F 2α (PGF 2α) and its methyl analogue for the termination of pregnancy associated with medical complications, prior laparotomy and uterine scars or tumours and abnormal pregnancies in 50 patients is presented. Complete or incomplete abortion occurred in 40 patients within 48 hours and in all of them within 78 hours. Vomiting and diarrhoea were the minor side effects encountered in a few patients. Two patients had blood losses of more than 500 ml. These results compare favourably with those results reported earlier on termination of pregnancy with prostaglandin in normal women as regards success rate, induction-abortion interval and side effects. This analysis indicates that PGF 2α and 15-me-PGF 2α are reasonably safe and effective for termination of pregnancy in high risk patients.

Repeated vaginal administration of 15-methyl PGF 2α methyl ester for termination of pregnancy in the 13th–20th week of gestation

In a comparative multicentre trial, vaginal suppositories containing 1.5 mg 15-methyl prostaglandin F 2α methyl ester were administered at 3-hour intervals to 310 patients. Abortion of the fetus occurred within 24 hours in 274 patients (88.4%) and within 30 hours in 285 patients (91.9%). The mean induction-abortion interval was 14.2 hours. Abortion was complete in 49.9 per cent of the cases. The most common side effects were vomiting and diarrhoea. The mean frequency of vomiting and diarrhoea was 2.8 episodes per patient for both types of side effects, while temperature elevation above 38 °C occurred in 11.7 per cent of the cases. Repeated vaginal administration of 15-methyl PGF 2α methyl ester is an effective, noninvasive method for termination of second trimester pregnancy. Further development of suppositories should achieve a longer action combined with a decrease in gastrointestinal side effects.