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%.
In a multicentre trial 139 women between 15 and 20 weeks of gestation were treated with 2.5 mg intraamniotic administration of 15(S)15 methyl PGF2α (Prostin 15M, Upjohn) for termination of pregnancy. Following treatment 97% of the primigravida and 94.5% of multigravida aborted. The induction abortion interval (Mean ± S.E.M.) in the primigravida was 22.8 ± 1.1 hours, while in the multigravida it was 18.3 ± 1.0 hours. The mean number of episodes of vomiting was 1.4 and 0.9 in primigravidae and multigravidae, respectively. The mean number of episodes of diarrhoea was 0.7 in both groups. Of the primigravidae 10.9% and of the multigravidae 21.7% had incomplete abortions. No injuries to the genital tract were reported.
The efficacy of 15(S)15 methyl PGF2α (Prostin 15M, Upjohn) was tested in controlling the bleeding during third stage of labour in women delivered at term. Prostin 15M was given in a dose of 125 µg by intramuscular route at the delivery of the anterior shoulder of the fetus. Prostin 15M significantly reduced the duration of third stage and blood loss to about a third of those who did not receive any oxytocic. The blood loss during 2 hours following delivery was also markedly reduced with Prostin 15M treatment.
The adjunctive use of laminaria tent along with intramuscular 15(S)15 methyl PGF 2 α (Prostin 15M, Upjohn) was studied for induction of second trimester abortion. Three hundred and two patients from eight centres were recruited for the study. Ninety‐two were primigravidae and 210 were multigravidae. One to three laminaria tents were inserted overnight and they were removed before the start of treatment with 250 µ g Prostin 15M administered intramuscularly every two hours till abortion. Of primigravida 81.5% and of the multigravidae 79.5% aborted within 24 hours of treatment. The induction abortion interval in the primigravida was 11.2 hours and in multigravidae it was 12.0 hours. The overall incomplete abortion rate was 31.0%. The pimigravidae had higher mean number of episodes of vomiting (2.5) and diarrhea (2.9) than the multigravidae (1.7 and 1.5, respectively). No other complications or injuries to genital tract were reported.
In a multicentre trial (3 centres) the safety and efficacy of an intramuscular injection of 125 µ g of 15(S)15 methyl PGF 2 α (Prostin 15M, Upjohn) was compared with methylergometrine for prophylactic control of bleeding during the third stage of labour. Three hundred patients were recruited for the study — 150 to each treatment group. The duration of the third stage was shorter in the patients (4.4 minutes) treated with Prostin 15M compared to the methylergometrine group (8.6 minutes). Similarly the blood loss during the third stage was reduced by 50% of that observed in the methylergometrine group (72 ml vs 145 ml). Prostin 15M, when used prophylactically was better than methylergometrine in controlling the blood loss during the third stage of labour.
A multicentre trial was carried out to find out the safety and efficacy of 15(S)15 methyl PGF2α (Prostin 15M, Upjohn) for induction of menses in early pregnancy (up to 49 days). Two hundred and eighty‐four cases were recruited for the study. All patients received two doses of 0.5 mg (2.0 ml) Prostin 15M by the intramuscular route and antiemetic and antidiarrhoeal medication prior to the administration of the prostaglandin analogue. The overall success rate (complete abortion) at two weeks evaluation visit was 87.7%. The success rate was 92% up to 42 days and 100% up to 35 days of the last menstrual period. The side effects were mainly gastrointestinal and majority of the patients had less than three episodes of vomiting or diarrhoea. The duration of bleeding was prolonged (up to 7 days) with Prostin 15M treatment. Intramuscular Prostin 15M seems to be effective in inducing menses in early pregnancy especially if the duration of amenorrhea is up to 35 days.
The effect of single intramuscular injection of 15(S)15 methyl PGF2α . (Prostin 15M, Upjohn) on cervical dilatation was tried in women during first trimester pregnancy. Prostin 15M was given at a dose of 250 µg. Three hours later the cervical dilatation and uterine consistency were assessed and recorded, prior to vacuum aspiration. The control group consisted of women who did not receive any drugs for cervical dilatation. The mean cervical dilatation in Prostin 15M group was 9.7 ± 2.3 (S.D.) mm compared to 3.4 ± 1.5 (S.D.) mm in the control group. This difference was statistically significant (p <0.01). Vomiting was experienced by 18.6% and diarrhea by 20.9% of the patients. There was no significant difference in the blood loss between the Prostin 15M group and the control group.
A multicentre trial of Prostin 15M in second trimester abortion in 322 patients of whom 115 were primigravidae was conducted during the period of six months. Intramuscular injection of Prostin 15M 250 µg was given two hourly till one centimeter dilatation of the cervix, followed by three hourly injections till abortion. The mean dose of Prostin 15M was 2.3 mg for primigravidae and 2.0 mg for the multigravidae. The mean induction abortion interval was 18.5 hours in primigravidae and 17 hours in multigravidae. Two hundred and seventy‐six patients (85.7%) aborted with the treatment. There were 26 failures in primigravidae (22.6%) and 20 failures in the multigravidae (9.6%). Side effects of vomiting and diarrhoea were 3.0 and 4.1 episodes, respectively. In 53 cases where prophylactic antidiarrhoeal drug loperamide and antiemetic emidoxyn were given, the incidence of diarrhoea and vomiting was reduced to 1.6 and 1.7, respectively. There were no serious complications. In 50 cases the blood loss, as measured by alkaline hematin method was 25.4 ml (mean).
Les β 1 glycoproteines sont mesurees a differentes semaines de la gestation chez des femmes a grossesse normale et chez des femmes a grossesse pathologique. Les auteurs, concluent que la mesure des β 1 glycoproteines peut etre un parametre valable pour controler la fonction placentaire
In a trial of 71 women, 15(S) 15 methyl PGF2α 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.
Immunosuppressive properties of human chorionic gonadotropin (HCG), pregnancy specific B1-glycoprotein (SP-1), human alpha foetoprotein (AFP), and human placental lactogen (HPL) in mitogen-stimulated lymphocyte transformation were studied. A pregnancy serum containing high serum levels of these specific proteins was prepared from a number of pregnancy sera. The inhibitory effect of pregnancy sera on lymphocyte response to mitogen was examined after sequential removal of each of the proteins from the pregnancy serum by affinity chromatography. Greatest decrease in the suppression was observed when human chorionic gonadotropin (HCG) alone or human chorionic gonadotropin in combination with all other three specific proteins was removed from the pregnancy serum. Pregnancy specific B1-glycoprotein (SP-1) also significantly decreased the inhibitory effect of pregnancy serum. But the other two specific proteins (AFP and HPL) had minimal effect on the decrease an immunosuppression by pregnancy serum. However, even after removal of all the four pregnancy specific proteins from the pregnancy serum, complete return to normal values for lymphocyte transformation by mitogen was not observed, which indicates the presence of some other suppressive factor(s) in the pregnancy serum.
Five fractions of human seminal plasma were isolated on Sephadex G-100 column. The in vitro effect of whole human seminal plasma and its fractions on the lymphocyte transformation induced by phytomitogen was studied. A significant inhibition of lymphocyte response to mitogen was observed with whole seminal plasma fractions I and III at a concentration of 100-200 micrograms/ml. However fraction II stimulates the in vitro human lymphocyte transformation induced by phytomitogen at a concentration of 200 micrograms/ml. Maximum amount of inhibition by whole seminal plasma and its fractions I and III was achieved by preexposure of lymphocytes to these antigens. Pre-exposure of lymphocytes to these antigens, followed by washing, does not result in suppression of lymphocyte response to mitogen. These observations suggest that the antigens of the whole seminal plasma or of fractions I, III, and II act by simple competition with mitogen for the receptor sites on the lymphocyte membrane. Therefore, the human seminal plasma may play an immunoregulatory role against the auto- or isosensitization towards spermatozoal antigens.