Comparison of misoprostol and manual vacuum aspiration for the treatment of incomplete abortion.

OBJECTIVE: To compare the safety, efficacy, and acceptability of misoprostol versus manual vacuum aspiration (MVA) for treatment of incomplete abortion in Maputo, Mozambique. METHODS: A total of 270 women with clinically diagnosed incomplete abortions of up to 12 weeks of gestation were randomized to either 600 mug oral misoprostol or MVA. Women were followed-up seven days later to evaluate whether the abortion was complete. RESULTS: Success was high for both MVA and misoprostol groups (100% vs 91%, P=0.002). Women in the MVA arm reported fewer side effects but higher pain scores. Women who received misoprostol were significantly more likely to be "very satisfied" with the treatment and willing to choose the method again. CONCLUSION: Although oral misoprostol was less effective than MVA in this study, it was more acceptable to women. Misoprostol is well-suited for use in low-resource settings, and should be promoted as an option for the treatment of incomplete abortion.

Improving emergency obstetric care in Mozambique: the story of Sofala.

OBJECTIVE: The 5-year project in the province of Sofala was designed to improve access, quality and utilization of emergency obstetric care (EmOC) by strengthening rural hospitals and health centers and ultimately the health system's capacity to respond to emergencies more quickly and effectively. METHODS: Implementation consisted of attention to infrastructure, human resource development, transportation and communication systems, and management. Specific management aspects that were targeted for improvement included: supportive supervision, logistics for supplies, equipment and drugs, record keeping, monitoring and evaluation, and quality improvement techniques such as maternal death audits. RESULTS: Access to EmOC improved with an increase in the number of fully functional EmOC facilities from 4 to 18. The number of women with obstetric complications who were admitted for treatment in participating facilities tripled, and the proportion of those women dying declined by half. CONCLUSIONS: Close collaboration and partnership with the provincial health directorate make the sustainability of many results likely while the replication of much of the Sofala model to other provinces is promising for the national strategy to reduce maternal mortality.

Application of vaginal misoprostol before cervical dilatation to facilitate first-trimester pregnancy interruption.

OBJECTIVE: To study the capacity of vaginal misoprostol to soften the cervix and facilitate cervical dilatation in women undergoing first-trimester pregnancy interruption. METHODS: We performed a double-blind, placebo-controlled study in 100 women opting for voluntary pregnancy interruption. The subjects were randomly allocated to two treatment groups, receiving either 200 micrograms misoprostol or placebo in the posterior vaginal fornix 6 hours before cervical dilatation. We noted the number of women with vaginal bleeding, with chorionic tissue in the vagina, or with no resistance to a Hegar 8 dilator, and recorded the total time in minutes for pregnancy interruption. RESULTS: Vaginal bleeding from the cervix occurred in 70% of the misoprostol group and in 8% of the placebo group (odds ratio 26.83; 95% confidence interval [CI] 9.73-74.00). Almost one-fourth (22%) of the misoprostol-treated women had chorionic tissue in the vagina, compared to one woman (2%) in the placebo group (odds ratio 13.82; 95% CI 2.59-73.61). Cervical dilatation was achieved in 74 and 10% of the misoprostol- and placebo-treated women, respectively (odds ratio 25.62; 95% CI 9.61-68.28). The time required for pregnancy interruption was significantly shorter with misoprostol (P < .004). CONCLUSION: Misoprostol is significantly more effective in facilitating cervical dilatation than is placebo. The average intervention time for pregnancy interruption was reduced by 35%.

Evaluation of the effectiveness of vaginal misoprostol to induce first trimester abortion.

Two doses, 200 and 400 micrograms, of misoprostol, administered vaginally every 12 hours, up to four times, were tested in 101 and 133 healthy women, respectively, for interruption of pregnancies with 35 through 77 days of amenorrhea. The proportion of women who aborted increased with longer duration of treatment and was significantly higher with 400 than with 200 micrograms (66 versus 46 percent at 48 hours). Significance was maintained after controlling by age, body weight, parity, previous abortion and gestational age. Abortions were classified as incomplete or complete, according to the presence or not of embryonic tissue in the uterine cavity, diagnosed by vaginal sonography. Vacuum aspiration was carried out in all cases not classified as complete abortion 48 hours after the initiation of treatment, or earlier in case of persistent bleeding or woman's request. The possibility of increasing effectiveness by using higher dose, shorter intervals or longer duration of treatment is discussed.

Low-dose vaginal misoprostol for induction of labor with a live fetus.

OBJECTIVE: To test the effectiveness and safety of low-dose vaginal misoprostol for induction of labor with a live fetus. METHODS: Labor was induced in 666 pregnant women with a live fetus in the cephalic position, who had no medical complications and no history of uterine surgery. One-fourth of a 200-micrograms tablet of misoprostol (50 micrograms) was placed in the posterior vaginal fornix every 12 h for a maximum of four doses or until active labor commenced. Time from induction to delivery, side effects and neonatal outcome were evaluated. RESULTS: Labor was successfully induced in all cases. The mean time from induction to delivery was 10.4 h. The cesarean section rate was 7.8%. There were eight perinatal deaths, six of which occurred in low birth weight fetuses. There was one case of abruptio placenta, which was less than that expected in the study population. CONCLUSION: Vaginal misoprostol, in very low doses, was a remarkably efficient and safe method for induction of labor with a live fetus.

Reducing maternal mortality in Mozambique: challenges, failures, successes and lessons learned.

The aim of this paper is to describe different approaches to make emergency obstetric care (EmOC) accessible to women in Mozambique. The definitions of basic (BEmOC) and comprehensive EmOC (CEmOC), proposed by the UN agencies, were adopted by FIGO and by the Mozambican Ministry of Health as a general strategy to reduce maternal mortality. Four projects are presented: (1) José Macamo and (2) Mavalane Hospitals in Maputo city, (3) Manhiça District in Maputo Province and (4) Sofala Province. José Macamo was staffed by physicians 24 h a day; other hospitals by non-physicians trained in surgical and anesthesiology techniques, as well as nurse-midwives. José Macamo Hospital provided CEmOC to the city of Maputo and the southern area of Maputo Province. In 2001, this hospital attended 32% of deliveries and 38% of cesarean sections in the city, up from 14 and 2.5%, respectively, in 1998. The Mavalane Hospital failed to provide CEmOC; however, the number of deliveries per year almost doubled. The Manhiça hospital carried out 31% of the District's C-sections in 2001, up from 9% in 1998. In Sofala Province, one additional CEmOC and four BEmOCs were installed and case fatality rates decreased. In conclusion, the strategy for ensuring provision of EmOC is feasible even in countries with minimal resources and a scarcity of physicians, such as Mozambique.

Labor induction by vaginal misoprostol in grand multiparous women.

BACKGROUND: Grand multiparous women in poor and under-privileged settings run a high risk of uterine rupture at labor induction. The purpose was to elucidate whether vaginal misoprostol medication is a safe and cost-effective alternative induction method in grand multiparous women, in whom, under prevailing circumstances, induction by oxytocin is associated with high risk of adverse maternal outcome of pregnancy. METHOD: One hundred and sixty-five grand multiparous parturient women with five or more previous deliveries were divided into two groups. The first group (n=134) had the fetus alive and the second (n=31) had late intrauterine fetal death. Both groups were subject to induction of labor by use of vaginal misoprostol in a dose of 50 microg (live fetus) and 100 microg (intrauterine fetal death). No additional oxytocin was utilised. RESULTS: Labor induction by vaginal misoprostol was successful in grand multiparous women. The proportion of women requiring a Cesarean section was 6.0%, which is less than one third of the average Cesarean section rate in the setting studied. Women with fetus alive had significantly shorter application-to-expulsion interval (AEI) than women with fetal death (10.1 versus 15.4 hours; p=0.039). Significantly shorter AEI was recorded in women with prelabor rupture of membranes (9.1 hours) than in women with intact membranes (12.9 hours) (p=0.01). With Bishop's score > or = 5 and < 5 AEI was 8.7 hours and 14.4 hours, respectively (p=0.001). No significantly adverse neonatal or maternal outcomes of pregnancy were registered and it was specifically noted that no uterine rupture occurred among the 165 grand multiparous women induced. CONCLUSIONS: Induction of under-privileged grand multiparous women with live fetus or with fetal death can be performed safely and cost-effectively by vaginal misoprostol.

Vaginal misoprostol as an alternative to oxytocin for induction of labor in women with late fetal death.

BACKGROUND: Induction of labor in women with late fetal death is often difficult in settings with scarce resources. The purpose of this study was to assess the value of vaginal misoprostol for induction of labor in women with such fetal death. METHODS: In Maputo 156 women with late fetal death were allotted in a non-randomised way to either vaginal misoprostol or intravenous infusion of oxytocin. Treatment outcomes were compared as to cost-effectiveness and safety. In the misoprostol group none received more than 800 micrograms. Oxytocin infusion followed an established routine. Statistical analyses were performed by EPI Info software. RESULTS: In cases with Bishop's score < 6 the induction-to-delivery interval averaged 14.8 hours in the misoprostol group and 31.0 hours in the oxytocin group (p = 0.001). The corresponding values for women with Bishop's score > or = 6 were 6.6 and 8.7 hours, respectively (p = 0.4). Women with intact membranes had an induction-to-delivery interval of 13.8 hours in the misoprostol group and 26.9 hours in the oxytocin group (p = 0.002). The corresponding values in women with ruptured membranes were 7.8 and 10.5 hours, respectively (p = 0.6). Successful induction was achieved in 81% of misoprostol-treated women at a dose of 100 micrograms or less. CONCLUSIONS: Vaginal misoprostol is a safe, low-cost drug particularly suitable in women of high average parity having late, fetal death.

Induction of labor with intravaginal misoprostol in intrauterine fetal death.

OBJECTIVE: Our purpose was to evaluate the effectiveness and safety of intravaginal misoprostol for the induction of labor in intrauterine fetal death. STUDY DESIGN: Seventy-two women at 18 to 40 weeks of pregnancy with intrauterine fetal death, without abdominal scars, were treated with 100 micrograms of intravaginal misoprostol. The dose was repeated every 12 hours until effective uterine contractions and cervical dilatation were obtained, for up to 48 hours. RESULTS: The mean time from induction to delivery was 12.6 hours, and only six patients (8%) required between 24 and 48 hours, at the end of which all patients had been delivered. Only the Bishop's score was significantly associated with time from first dose to expulsion. No surgical procedure was required. Hypercontractility, sweating, fever, diarrhea, or other gastrointestinal effects were not detected. There was no need for analgesics. CONCLUSIONS: Intravaginal misoprostol at the dose of 100 micrograms every 12 hours appears to be a safe, effective, practical, and inexpensive new method for induction of labor in intrauterine fetal death.

PIP: Physicians at the Maputo Central Hospital in Mozambique inserted at least 100 mcg misoprostol into the vaginas of 72 women with intrauterine fetal death at 18-40 weeks pregnancy to induce labor. They inserted another dose every 12 hours up to 48 hours if a patient had not begun labor. The mean time between induction of labor to delivery stood at 12.6 hours. 92% delivered within 24 hours. All had delivered by 48 hours. The time between 1st dose and expulsion was significantly lower for women with a Bishop's score of more than 5 than for those with a score of 5 and lower (7.6 vs. 13.7 hours; p = .028). Bishop's score was the only variable associated with time to expulsion. (It is used to estimate the prospects of labor by evaluating the extent of cervical dilatation, effacement, station of the head, consistency of the cervix, and cervical position in relation to the vaginal axis.) No one died, needed surgery either before or after delivery, or suffered side effects. The physicians noted that this regimen greatly reduced costs, staff workload, and time. These findings suggest that intravaginal misoprostol at a dose of 100 mcg/12 hours is a safe, effective, practical, and inexpensive new way to induce labor in cases of intrauterine fetal death.

Pregnancy interruption by vaginal misoprostol.

A total of 132 pregnant women with average gestational age of 14.2 weeks (range 11-22 weeks) undergoing legal abortion volunteered for a trial utilizing vaginal administration of misoprostol. In 106 women a dose of 800 micrograms was utilized, whilst in 26 women 1,200-1,600 micrograms were given. Nonsurgical expulsion of the fetus was successful in 117 cases (88.6%). Four cases had to be excluded for various social reasons. A total of 11 did not achieve fetal expulsion within 56 h after application of misoprostol. These cases (11/132; 8.3%) were considered failures. Previous reports in the literature of toxicity trials on animals reporting no fetotoxic nor teratogenic effects of misoprostol at doses up to 10,000 micrograms/kg body weight seem to be of no validity in the human since we could demonstrate that almost 80% of pregnancies were interrupted at a dose of 10-15 micrograms/kg body weight. The conclusion is that vaginal administration of this prostaglandin analogue, not requiring cool temperature for storage, is remarkably effective in achieving safe interruption of pregnancy without any significant complications.

The effectiveness of intravaginal misoprostol (Cytotec) in inducing abortion after eleven weeks of pregnancy.

At Maputo Central Hospital in Mozambique, intravaginal misoprostol, a PGE2 methyl-analogue, was used by 169 women whose request for interruption of pregnancy had been approved. The drug was used by women who had completed between 12 and 23 weeks of gestation. The initial dose was 800 micrograms, repeated 24 hours later if abortion had not occurred or was not in progress. The treatment was considered a failure when abortion was not advanced by 48 hours after the initial dose, and curettage was performed in all but one of such cases. During the course of the study, the dosage was successively reduced to 600, 400, and 200 micrograms. Abortion was successfully induced in 154 women (91.1 percent); there were 10 failures (5.9 percent), and five women (3.0 percent) dropped out of the study. The mean time from initial dose to abortion was 14.3 hours. No significant association of success rate and time from dosage to expulsion was found with age, parity, previous abortion, or gestational age. Preventive vacuum aspiration of the uterine cavity was carried out on all subjects.

A comparative study of vaginal misoprostol and intravenous oxytocin for induction of labour.

Fifty-two women who had labour induced by intravenous oxytocin were compared with 404 women in whom labour was induced by vaginal misoprostol (50-150 micrograms). The induction-to-delivery intervals in the oxytocin and misoprostol groups, respectively, had the following durations. With Bishop's score < 6, 24.3 vs. 14.4 h (p = 0.002), with Bishop's score > or = 6, 10.5 vs. 7.6 h (p = 0.02), with ruptured membranes, 8.8 vs. 8.5 h (p = 0.83), and with intact membranes, 19.6 vs. 13.1 h (p = 0.005). The Caesarean delivery rate was 17.3% in the oxytocin group and 8.7% in the misoprostol group (p = 0.09). Maternal complications were few and drug side effects rare. It is concluded that vaginal misoprostol is a valuable and cost-effective alternative to intravenous oxytocin infusion for induction of labour.

Uterine evacuation by vaginal misoprostol after second trimester pregnancy interruption.

BACKGROUND: The purpose was to study the capacity of vaginal misoprostol in combination with methylergometrine to achieve complete evacuation of the uterus without ensuing surgical evacuation of the uterine cavity. METHODS: We performed this trial on 228 women seeking pregnancy interruption. Vaginal misoprostol was given in a dosage of 800 micrograms in early second trimester. All women received concomitant treatment with peroral methlyergometrine from the moment of misoprostol application every 8 hours until uterine evacuation. Follow-up was continued until the first menstruation after interruption. RESULTS: Complete uterine evacuation was achieved in 173/228 cases (76%) [group 1]. The remaining 55 women [group 2] underwent manual evacuation of placental remnants trapped in the cervix. In seven of these women a conventional curettage was carried out due either to ultrasound evidence of placental remnants or due to uterine bleeding. The interval between misoprostol application and fetal expulsion averaged 14.9 hours (s.d. 9.6) in group 1 and 21.0 hours (s.d. 14.5) in group 2 (p=0.006). CONCLUSIONS: Misoprostol, in combination with methylergometrine, is a remarkably efficient drug in achieving uterine evacuation also in the absence of surgical evacuation of the uterine cavity. The present study provides justification for a more expectant attitude after vaginal misoprostol treatment for pregnancy interruption. The avoidance of close to 80% of otherwise conventional curettages would seem to represent a major advantage, particularly in settings where manpower and material resources are scarce.