A 10-year follow-up study of contraceptive Norplant implants.

OBJECTIVES: To evaluate the long-term efficacy and health problems associated with Norplant implants and re-implants after 5 full years of first implants. METHOD: From 1984 to 1988, 1657 women accepted first implants of Type I and Type II of Norplant, and 394 first acceptors had a re-implant, at a clinic for study. The clinical records and annual follow-up data of acceptors were analyzed. The life-table technique was the main method used. RESULTS: The continuation rates were very high. The cumulative pregnancy rates at 1, 3 and 5 full years of use were 0.0%, 0.1% and 0.7%, respectively. Users with heavier body weight had higher pregnancy rates. The rate of menstrual disturbances peaked at 73% after 3 months and consistently decreased to 20% at 5 years of use. Rates of menstrual disturbances associated with re-implants were much lower. CONCLUSION: Norplant is extremely effective and safe for long-term use.

An analysis of vaginal bleeding patterns in users of Norplant implants.

PIP: A 5-year prospective study of 548 Norplant acceptors at Shanghai (China) Medical University assessed self-reported vaginal bleeding patterns over time. Between the first 90-day reference period and the last such period, spotting decreased from an average of 21.5 to 9.5 days, bleeding declined from an average of 11 to 9.9 days, and heavy bleeding remained relatively constant at 0.5-1.0 days. Overall, the average total of bleeding and spotting days decreased from 33 days in the first 90-day period to 26.7 days in the fourth 90-day period and to 20.2 days in the 20th reference period. Only 0.5-5.4% of women experienced amenorrhea during the various reference periods. Careful counseling of Norplant acceptors about the likelihood of increased vaginal bleeding during the early period of method use is essential to reduce requests for removal.^ieng

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.

Termination of early pregnancy by two regimens of mifepristone with misoprostol and mifepristone with PG05--a multicentre randomized clinical trial in China.

A multicentre randomized open clinical trial was conducted to compare the efficacy and side effects of two regimens of mifepristone with misoprostol, and mifepristone with PG05 for termination of early pregnancy (amenorrhoea < = 49 days). Six-hundred women in early pregnancy, who requested medical abortion were randomly allocated into 3 groups. In group 1 (n = 301), an initial dose of mifepristone 50 mg was given, followed by 25 mg every 12 hours up to a total dose of 150 mg mifepristone, plus a single oral dose of misoprostol 600 micrograms in the morning of the third day. In group 2 (n = 150), the same regimen of mifepristone was given, but dl-15-methyl PGF2 alpha (PG05) 1 mg vaginal suppository was inserted on the third day. In group 3 (n = 149), a single dose of mifepristone 200 mg was given and misoprostol 600 micrograms was used as in group 1. The complete abortion rate were 94.4%, 97.3%, and 94.6% for group 1, 2 and 3, respectively. 3.0, 2.0 and 2.7% of women had incomplete abortion, and 1.7, 0.7 and 2.0% of women in the 3 groups were treatment failures; in the remaining 1% in group 1 and 0.7% in group 3, treatment outcome could not be determined. There were no significant differences among the 3 groups. Lower abdominal pain was the main complaint which was reported by 82% of the subjects after PGs administration. The incidence of diarrhoea in PG05 group (38.7%) was significantly higher than that in the other two groups (21.6 and 20.1%) (P < 0.001), and so was vomiting. It was concluded that misoprostol, as an orally effective prostaglandin, in combination with mifepristone for induced abortion of early pregnancy was as effective as PG05 vaginal suppository. Besides, it has advantages of convenience of use, less side effects, easy storage and transfer, and low cost.

A 5-year evaluation of NORPLANT contraceptive implants in China.

OBJECTIVE: To assess the efficacy, safety, and acceptability of NORPLANT implants when used by Chinese women. METHODS: In a prospective, multicenter clinical trial, 10,718 women selecting NORPLANT implants were monitored semiannually for the first 2 study years and then annually through 5 years. Life table rates of pregnancy and other terminations were calculated, as were incidence rates of serious conditions leading to termination. RESULTS: The 5-year average annual pregnancy rate was 0.3 per 100 and the ectopic pregnancy rate was minimal, 0.09 per 1000 woman-years. Pregnancy rates correlated significantly with weight, but regardless of weight group, annual average pregnancy rates were less than one per 100. Younger women experienced higher pregnancy rates than did older users. Headache, myoma, dizziness, and weight gain led more frequently to termination than did other adverse events apart from menstrual disturbances. Mortality during use was 2.0 per 10,000 years, based on 44,954 years of experience. There were no cardiovascular or cerebrovascular deaths, and no deaths were attributable to NORPLANT use. Seventy-two per 100 initial acceptors used the implants continuously for 5 years. CONCLUSION: NORPLANT implants proved highly effective, safe, and acceptable among Chinese women regardless of province, age, or weight at admission.

Study of Norplant implants in Shanghai: three-year experience.

A clinical follow-up study conducted in Shanghai, China confirmed earlier reports that the Norplant implants, Norplant-1 and Norplant-2, are both highly effective with high continuation rates. The implants, however, tend to cause menstrual disturbance, spotting and bleeding. The mean hemoglobin value, however, did not change and the blood pressure remained stable. The report of 8 cases of thrombocytopenia among 301 Norplant-2 users is a source of concern.

[Termination of pregnancy with 16,16-dimethyl-trans-delta2 PGE1 methyl ester vaginal suppositories: an analysis of 182 cases].

PIP: The results of pregnancy termination with ONO 802 as a vaginal suppository in 182 cases are presented. The drug was tested during the different phases of pregnancy, as well as in abnormal pregnancies (intrauterine fetal death and hydatidiform mole) and normal pregnancy. 1 suppository containing 1 mg of the drug was inserted in the posterior vaginal fornix every 3 hours, with 1 full course consisting of 5 suppositories. Cases which did not terminate spontaneously were administered the same treatment the next day. A success rate of 90.5% was obtained; 91.6% for the 1st trimester, 88.8% for the 2nd, 94.7% for intrauterine fetal death, and 100% for hydatidiform mole and 3rd trimester cases. A dosage of between 1-5 mg was successful in 83.9%. 75% terminated within 24 hours. In the 34 patients who were given 2 suppositories and whose surgical termination followed 6 hours later, the cervix was so soft and dilated that a No. 8 Hegar dilator was easily inserted and blood loss was reduced to an average of 12.5 ml. After termination, vaginal bleeding ceased within 2 weeks and menses resumed in 6 weeks. Few complications and side effects occurred. Of the 8 cases which later became pregnant, 2 have delivered normal fetuses spontaneously. In light of these results, the use of ONO 802 vaginal suppository is 1 of the better methods of pregnancy termiantion. (author's modified)^ieng