Safety, efficacy, and acceptability of medical abortion in China, Cuba, and India: a comparative trial of mifepristone-misoprostol versus surgical abortion.

OBJECTIVE: We investigated safety, efficacy, and acceptability of an oral regimen of medical abortion compared with surgical abortion in three developing countries. STUDY DESIGN: Women (n = 1373) with amenorrhea < or = 56 days chose either surgical abortion (as provided routinely) or 600 mg of mifepristone followed after 48 hours by 400 micrograms of misoprostol. This is the appropriate design for studying safety, efficacy, and acceptability among women selecting medical abortion over available surgical services. RESULTS: The medical regimen had more side effects, particularly bleeding, than did surgical abortion but very few serious side effects. Failure rates for medical abortion, although low, exceeded those for surgical abortion: 8.6% versus 0.4% (China), 16.0% versus 4.0% (Cuba), and 5.2% versus 0% (India). Nearly half of failures among medical clients were not true drug failures, however, but surgical interventions not medically necessary (acceptability failures or misdiagnoses). Women were satisfied with either method, but more preferred medical abortion. CONCLUSION: Medical abortion can be safe, efficacious, and acceptable in developing countries.

PIP: A multi-center comparative study of medical compared to surgical abortion confirmed that medical abortion can be safe, effective, and acceptable in developing countries. A total of 1373 women from medical centers in China, Cuba, and India with pregnancies of 56 days' gestation or less were given the choice of surgical abortion or 600 mg of mifepristone followed after 48 hours by 400 mcg of misoprostol. Since the majority selected medical abortion, researchers in China and Cuba assigned some of these women to the surgical group to equalize the size of the two groups. The surgical abortion failure rates in China, Cuba, and India were 0.4%, 4%, and 0%, respectively, while the failure rates for medical abortion were 8.6%, 16.0%, and 5.2%, respectively. In all sites, both medical failures (an adverse effect resulting in a medically indicated surgical intervention) and acceptability failures (failure to complete the entire regimen) contributed substantially to the gross failure rates for medical abortion. Medical abortion failure rates increased with gestational age. Although cramping, nausea, and vomiting were more frequent among women in the medical abortion group and bleeding was heavier, general assessments of well-being reported at exit interviews did not differ between the two treatment groups at any site. Regardless of abortion method, the majority of women were either satisfied or highly satisfied with the procedure. In all countries, a higher number of medical than surgical abortion patients indicated they would opt again for the same procedure. Neither the bleeding pattern nor the higher failure rate associated with medical abortion justify withholding this option from women in developing countries.

Cervical dilatation in late first trimester termination by prostaglandin, hylase and isogel.

Pre-operative dilatation of the cervix was attempted in 223 cases prior to vacuum aspiration in patients seeking late first trimester termination beyond ten weeks. 15 Me PGF2a was used in the form of vaginal suppositories, intramuscular and intracervical injections. Dilatation of cervix of 10 mm or more was achieved within 4 hours in 86% cases with intra-cervical injections. Gastro-intestinal disturbances caused by intra-muscular injections could be avoided by intra-cervical injections, as the amount of prostaglandin required was only 100 ugm, but the success rate was significantly lower. The success with multiple dose suppositories was 80%. There was no significant difference in the success with 1.5 mgm or 1.0 mgm dosage, but the side effects were significantly higher with 1.5 mgm suppositories. Intra-cervical Hylase did not dilate the cervix but successfully softened it within 5 minutes to make metallic dilatation simple. The hygroscopic Isogel tents achieved dilatation of 10 mm or more in 73% of the patients in 12 hours. The tents as well as intra-cervical prostaglandin injection had the disadvantage of requiring an additional theatre procedure prior to suction curettage.

PIP: Preoperative dilatation of the cervix was attempted in 223 cases prior to vacuum aspiration in patients seeking late first trimester termination beyond 10 weeks. 15 Me PGF2alpha was used in the form of vaginal suppositiories, intramuscular and intracervical injections. Dilatation of cervix of 10 mm or more was achieved within 4 hours in 86% cases with intracervical injections. Gastrointestinal disturbances caused by intramuscular injections could be avoided by intracervical injections, as the amount of (PG) prostaglandin required was only 100 ugm, but the success rate was significantly lower. The success with multiple dose suppositories was 80%. There was no significant difference in the success with 1.5 mgm or 1.0 mgm dosage, but the side effects were significantly higher with 1.5 mgm suppositories. Intracervical Hylase did not dilate the cervix but successfully softened it within 5 minutes to make metallic dilatation simple. The hygroscopic Isogel tents achieved dilatation of 10 mm or more in 73% of the patients in 12 hours. The tents as well as intracervical PG injection had the disadvantage of requiring an additional theater procedure prior to suction curettage.

Flurbiprofen in the treatment of primary dysmenorrhoea.

1 In a double-blind crossover study, flurbiprofen produced marked relief of pain which was significantly more than with aspirin and placebo in patients suffering from primary dysmenorrhoea. In contrast, there was no significant difference between the relief of pain obtained with aspirin and placebo. 2 The clinician's overall assessment of efficacy also indicated that flurbiprofen produced better response as compared to aspirin and placebo in these patients with dysmenorrhoea. 3 Both flurbiprofen and aspirin did not produce any apparent adverse effects on blood loss during the menstrual period. 4 In conclusion, the analgesic effect of flurbiprofen seen in this trial establishes the therapeutic usefulness of the drug in the treatment of primary dysmenorrhoea.

Place of laparoscopy in pelvic inflammatory disease.

PIP: 577 laparoscopic examinations were performed in women presenting with sterility, chronic abdominal pain, primary or secondary amenorrhea, and irregular menstrual periods. 125 cases of chronic pelvic inflammatory disease (PID) of both the tuberculous and nonspecific varieties were detected through this procedure. 59 of the 125 cases were diagnosed as tuberculous. Investigations prior to laparoscopy had yielded significant results in only 12 cases. 87 of the 125 cases had no abnormal clinical findings, and only 18 of the 37 tubo-ovarian masses were diagnosed by bimanual examination. These results indicate that laparoscopy is an invaluable tool for the diagnosis of PID. It can reveal peritubal adhesions, tubercles on the tubes, small tubo-ovarian masses, and hydrosalpinx cases that cannot be detected clinically. It is considered a more suitable tool than culdoscopy, which less frequently notes adhesions to the fallopian tubes and pathological conditions in the upper pelvis. Laparoscopy can play an especially valuable role in India as a prelude to tuboplasty, given the high incidence of pelvic tuberculosis. Of the 316 cases of primary sterility examined in this study, 51 had genital tuberculosis and 39 had nonspecific PID. Laparoscopy can also be useful in disproving cases wrongly labelled as chronic pelvic disease. 15 women in this study who reported chronic lower abdominal pain had normal findings, and only 13 cases of PID were confirmed among the 33 cases preoperatively diagnosed as PID. A significant number of PID cases are attributed to operative procedures such as hysterosalpingography and ventrisuspension that are repeated unnecessarily and without proper sepsis. Thus, the possibility of a flare-up of infection during laparoscopy, especially due to hydroperturbation, should be considered. Women in this study who were found to have PID were given postoperative antibiotics. No significant postoperative complications were observed.^ieng

Tubal factors in sterility: a laparoscopic study of 697 cases of sterility.

PIP: Of 697 cases of sterility, 491 had primary sterility and 206 secondary. The subjects' uterus, tubes, ovaries, pouch of Douglas and the pelvis were visualized. 26.4% had chronic pelvic inflammatory disease with tubal damage responsible for infertility. 17.5% had complete bilateral blocked tubes. 3% had partial block with delayed spill of the dye. 10% had pelvic tuberculosis. 12.8% of the primary sterility cases and 4.3% of the secondary cases had tuberculosis. Cases with frank tubercles and caseation were diagnosed as tuberculosis. Only 31% of the cases with pelvic pathology would have been diagnosed with clinical examination alone. Laparoscopy is preferable when chronic pelvic infection, especially tuberculosis, is suspected.^ieng

Coagulation studies in women on combination type of oral contraceptives.

PIP: In view of the controversy stemming from reports indicating young women who take combined types of oral contraceptives are at greater risk of venous thrombosis and cerebral or coronary thrombosis, a clinical investigation of blood coagulation changes among 41 oral contraceptive users and 25 controls was undertaken at the K.E.M. Hospital in Bombay, India. The 25 controls (Group A) were women who planned to begin using oral contraceptives but had not yet begun use. 16 of the 41 oral contraceptive users had been taking combined pills for 1 l/2 - 5 years (Group B) and the other 35 for more than 5 years (Group C). Coagulation parameters investigated were 1) prothrombin time; 2) partial thromboplastin time; 3) serum fibrinogen; 4) euglobulin clot lysis time; 5) platelet count; 6) platelet adhesiveness; and 7) platelet aggregation. Significant changes occurred in partial thromboplastin time, platelet count, platlet aggregation, and prothrombin time. Group B had a higher rise in prothrombin time than Group A and a rise in platelet aggregation and in partial thromboplastin time compared to Group A. Platelet counts were higher for both groups of oral contraceptive users than for the controls.^ieng

A study of psycho-social factors of out-of-wedlock pregnancies.

PIP: The study was conducted to find out a relationship between various psychosocial factors which may be a part of the milieu causing girls to become pregnant out of wedlock. 500 girls between the ages of 14-27 years were studied during a period of 1 year. It was revealed that though their physical and mental environment may be one of the causes of their problem, premarital sex is becoming a way of life with youngsters. The teenagers in India have no knowledge about sex and inadequate knowledge about birth control and the capacity to think about the responsibility ensuing thereof is completely lacking. They were not aware of their own biological role in the pregnancy they had come to terminate. Non-recurrence of this situation can be achieved to some extent through a well organized rehabilitation program in centers conducting medical termination of pregnancy as they need social, economic, and mental rehabilitation. There is an urgent and immediate need for sound and proper sex education for all young people and special contraceptive centers must be organized for unmarried people, where they can come without hesitation for advice regarding contraceptive measures. It is important that full confidentiality be maintained.^ieng

Mid trimester abortion by one shot administration of prostaglandin.

PIP: 268 cases in which mid trimester abortion in the 2nd trimester of pregnancy was performed by injecting prostaglandins by intra-amniotic route were studied. Details are presented of 1 study in which 100 cases had prostaglandin injected intraamniotically in 1 shot. 50 cases received 50 mg of PGF2a and 40 received 2.5 mg of 15 Methyl PGF2a, an analogue more potent and longer acting. The majority of the patients were primigravida, most of these being unmarried mothers. The average gestation period in both groups was between 17-18 weeks. The average induction onset interval was considerably shorter in PGF2a group, but its abortion time was just about 1 hour less than that of the methyl analogue. The average incidence of vomiting is about 2-folds and that of loose motionsis almost 5 times in the 15 Methyl group. 81% of the patients were followed up, and 86% of this group stopped bleeding within 10 days and the remaining within 20 days. There has not been a single incidence of post abortal infection. The disadvantages associated with the original intravenous administration of prostaglandin have been overcome by using the intra-amniotic routes. 1 of the greatest advantages of 1 shot intra-amniotic PGF2a 50 mg was a low incidence of incomplete abortion. Only 12% of cases in this group had retained placenta compared to 40-50% in the other groups.^ieng

Cervico-vaginal injuries in cases of second trimester termination of pregnancy.

Midtrimester abortions were induced in 796 women by Hypertonic Saline and Prostaglandins. Intra-amniotic and Extra-amniotic routes were used for saline and Intra-amniotic, Extra-amniotic andaline and Intra-amniotic, Extra-amniotic and Intra-muscular routes were used for Prostaglandins. Seven patients had cervico-vaginal injuries. All were young nulliparous patients. None of them developed any signs and symptoms of shock. Five out of the seven injuries were posteriorly situated. The etio-pathology and preventive measures of such injuries are discussed here.