Misoprostol for Labor Induction in Obese Pregnant Women
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Maryland, Baltimore
Disqualifiers: Cesarean history, Placenta previa, HIV, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI \>40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the drug Misoprostol for labor induction in obese pregnant women?
Research shows that Misoprostol is effective for inducing labor, with studies indicating it can lead to vaginal delivery within 24 hours more effectively than some other methods. In obese pregnant women, it has been found to be an efficient labor induction agent with good maternal outcomes and low complications.
12345Is Misoprostol safe for inducing labor in obese pregnant women?
Misoprostol (Cytotec) has been used for inducing labor, but it is not FDA-approved for this purpose due to its potential risks, including reports of maternal and fetal deaths. However, studies suggest that when used appropriately, the absolute risks are low, and it can be effective with good maternal outcomes and low complications in high-risk pregnancies.
23678How does the drug Misoprostol differ from other treatments for labor induction in obese pregnant women?
Misoprostol is unique because it can be administered vaginally or orally, with vaginal administration showing faster results in inducing labor compared to oral use. It is more effective than oxytocin or prostaglandin E2 in achieving vaginal delivery within 24 hours, and it has a lower cesarean delivery rate compared to oxytocin alone.
234910Eligibility Criteria
This trial is for morbidly obese pregnant women with a BMI of 40 or higher. They must be between 34 and 42 weeks along, over 18 years old, carrying one baby in the head-down position, and have less than five contractions per ten minutes. Women who don't speak English or Spanish or have other health conditions that could interfere are not eligible.Inclusion Criteria
I speak English or Spanish.
Contractions < 5 per 10 minutes
I am morbidly obese with a BMI of 40 or higher.
+4 more
Exclusion Criteria
History of cesarean delivery
Fetal growth restriction with abnormal umbilical artery Doppler indices
Contractions >5 per 10 minutes
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either 25 mcg or 50 mcg vaginal misoprostol every 4 hours for induction of labor
Until delivery
Follow-up
Participants are monitored for safety and effectiveness after delivery
4 weeks
Participant Groups
The study is testing two different doses of Misoprostol (25 mcg vs. 50 mcg) to see which is more effective at starting labor in morbidly obese women to potentially reduce the need for cesarean delivery by improving rates of vaginal birth.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention - 50 mcg vaginal misoprostolExperimental Treatment1 Intervention
Participants will receive 50 mcg vaginal misoprostol every 4 hours.
Group II: Control - 25 mcg vaginal misoprostolActive Control1 Intervention
Participants will receive 25 mcg vaginal misoprostol every 4 hours.
Misoprostol is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Cytotec for:
- Abortion
- Cervical Ripening
- Gynecological Conditions
- Duodenal Ulcer
- NSAID-Induced Ulcer Prophylaxis
- Stomach Ulcer
- Labor Induction
- Postpartum Bleeding
🇪🇺 Approved in European Union as Misoprostol for:
- Abortion
- Cervical Ripening
- Gynecological Conditions
- Duodenal Ulcer
- NSAID-Induced Ulcer Prophylaxis
- Stomach Ulcer
- Labor Induction
- Postpartum Bleeding
🇨🇦 Approved in Canada as Misoprostol for:
- Abortion
- Cervical Ripening
- Gynecological Conditions
- Duodenal Ulcer
- NSAID-Induced Ulcer Prophylaxis
- Stomach Ulcer
- Labor Induction
- Postpartum Bleeding
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Maryland Medical CenterBaltimore, MD
Loading ...
Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
References
Induction of labor with an unfavorable cervix: how does BMI affect success? (‡). [2022]Obesity places women and their babies at risk for obstetric and perinatal morbidity including induction of labor and cesarean delivery. We sought to evaluate the impact of body mass index (BMI) on successful induction of labor using misoprostol at our institution. The primary outcome was time to delivery. Secondary outcomes were number of doses of misoprostol, duration of oxytocin and cesarean delivery.
Induction of labor: the misoprostol controversy. [2019]Misoprostol (Cytotec) is safe and effective for induction of labor, although it is not approved by the Food and Drug Administration (FDA) for use in pregnancy. In August 2000, the manufacturer of misoprostol warned against its use in pregnancy because of its abortifacient properties and cited reports of maternal and fetal deaths when misoprostol was used to induce labor, fueling the misoprostol controversy. More than 45 randomized trials including more than 5400 women have found vaginal misoprostol to be more effective than oxytocin or vaginal prostaglandin E2 at effecting vaginal delivery within 24 hours. Cesarean delivery rates with vaginal misoprostol are lower than with oxytocin alone, but similar to prostaglandin E2. There have been no significant differences in the frequency of serious adverse maternal or neonatal outcomes with low-dose misoprostol compared with oxytocin or prostaglandin E2; however, the relative risk of rare adverse outcomes with misoprostol is unknown. The data suggest that absolute risks are low when misoprostol is used appropriately. We recommend 25 mcg vaginally every 4 to 6 hours for carefully selected patients in closely monitored settings. Whether misoprostol will prove to be the most cost-effective agent for inducing labor in women with an unfavorable cervix remains to be determined.
Is Misoprostol Vaginal Insert Safe for the Induction of Labor in High-Risk Pregnancy Obese Women? [2021]Induction of labor (IOL) is an event that occurs in up to 25% of pregnancies. In Europe, the misoprostol vaginal insert (MVI-Misodel®) was approved for labor induction in 2013. Studies on the outcomes and safety of IOL in obese pregnant women are scarce; no data are available on MVI IOL in high-risk pregnancy obese women (HRPO-late-term, hypertension, diabetes). As the obesity rates are growing steadily in pregnant women, we aimed to evaluate the failure rate for induction and the safety of a 200 μg MVI in obese (body mass index (BMI) >30 kg/m2) HRPO compared to that for obese non-high-risk pregnancies (non-HRPO). For this purpose, we conducted a cross-sectional study in "Filantropia" Clinical Hospital, Bucharest, Romania, from June 2017-the date of the initiation of the MVI IOL protocol in our clinic-to September 2019. The primary outcomes were the failure rate, measured by cesarean section (CS) ratio, and secondarily, the safety profile of MVI, analyzed by one-way ANOVA. Out of a total of 11,096 registered live births, IOL was performed on 206 obese patients. Of these, 74 obese pregnant women had their labor induced with MVI (HRPO, n = 57, and non-HRPO, n = 17). The average maternal age was 29.9 ± 4.8 years (19-44 years). Across the groups, the rate of CS was 29.8% (n = 17) in the HRPO group compared to 23.5% (n = 4) in the non-HRPO group (p = non significant). In the vaginally birth subgroups, the median time from drug administration to delivery was shorter in the HRPO group compared to the non-HRPO group (16.9 ± 6.0 h 95% confidence interval (CI) 15.0-18.8 vs. 19.4 ± 9.2 h 95% CI 13.8-25.0, p = 0.03). No significant differences were found regarding the maternal outcomes among the studied groups; in terms of perinatal outcomes of safety, 5.4% (n = 4) of the cases of vaginal delivery for HRPO were associated with neonatal intensive care unit (NICU) admissions. The MVI seems to be an efficient labor induction agent in high-risk pregnancy obese women with good maternal outcomes and low perinatologic complications.
Women's body mass index and oral administration of Misoprostol for induction of labor - A retrospective cohort study. [2022]Pregnant women who are obese are at greater risk of pregnancy complications, including preeclampsia, gestational diabetes, and macrosomia, leading to an increased likelihood of induced labor. Little is known about pregnant women with obesity and the dose of Misoprostol needed for induction of labor (IOL). To investigate whether the cumulative dose of Misoprostol needed for induction of labor (IOL) is associated with women's body mass index (BMI), we conducted a retrospective study of the use of oral Misoprostol for IOL at the Department of Obstetrics and Gynecology, Aarhus University Hospital - a tertiary referral delivery unit with 4800 deliveries a year. Data on IOL among 1637 women with singleton pregnancies was collected in the period January 1st, 2014, to October 4th, 2017. Low-risk women were induced in an outpatient setting. Primary outcomes were Misoprostol dose, time between start of induction (first dose of Angusta®) and completed delivery, and mode of delivery. Secondary outcomes were neonatal data as Apgar score and pH of the umbilical artery. In this study, we found the total dose of Misoprostol needed for induction increased significantly with increasing BMI (p
Labor outcomes of obese patients undergoing induction of labor with misoprostol compared to dinoprostone. [2018]The aim of the article is to evaluate and compare labor outcomes in obese patients undergoing induction of labor (IOL) with misoprostol and dinoprostone.
The freedom to birth-the use of cytotec to induce labor: a non-evidence-based intervention. [2021]The off-label use of Cytotec (misoprostol) to induce labor has increased over the past few decades. The increase in medical interventions in childbirth, many of which are not based on scientific evidence, and the rise in maternal and infant morbidity and in maternal and infant mortality cannot continue to go unrecognized. This column serves as a teaching tool for childbirth educators and provides an example of two unnecessary, potentially avoidable deaths that occurred during a birth with questionable medical interventions.
ACOG committe opinion. New U.S. Food and Drug Administration labeling on Cytotec (misoprostol) use and pregnancy. Number 283, May 2003. [2019]On April 17, 2002, the U.S. Food and Drug Administration approved a new label for the use of Cytotec (misprostol) during pregnancy. The new labeling does not contain claims regarding the efficacy and/or safety of Cytotec when it is used for cervical ripening for the induction of labor nor does it stipulate doses or dosing intervals. Therefore, the Committee on Obstetric Practice reminds Fellows that this agent should be used as previously recommended.
ACOG Committee Opinion. Number 283, May 2003. New U.S. Food and Drug Administration labeling on Cytotec (misoprostol) use and pregnancy. [2019]On April 17, 2002, the U.S. Food and Drug Administration approved a new label for the use of Cytotec (misoprostol) during pregnancy. The new labeling does not contain claims regarding the efficacy and/or safety of Cytotec when it is used for cervical ripening for the induction of labor nor does it stipulate doses or dosing intervals. Therefore, the Committee on Obstetric Practice reminds Fellows that this agent should be used as previously recommended.
Is vaginal misoprostol more effective than oral misoprostol for cervical ripening in obese women? [2021]Objective: To determine if vaginal misoprostol is more effective than oral misoprostol for cervical ripening in obese women.Study design: A retrospective cohort study of obese women undergoing induction of labor from Jan 2013 to Dec 2016 with singleton, viable pregnancies beyond 37 completed weeks of gestational age. Women with an initial Bishop score of 7 or less, with a cervical dilatation of less than 2 cm, who received either vaginal or oral misoprostol as a cervical ripening agent, were included. Primary outcome was interval from the start of induction to the attainment of 3 cm cervical dilatation. Secondary outcomes included the interval from the start of induction to delivery and the rate of cesarean delivery (CD).Result: Of women who met the inclusion criteria, 966 (75.5%) women received oral misoprostol and 314 (24.5%) received vaginal misoprostol. The mean time-interval from the start of induction to attainment of 3-cm dilatation was shorter in the vaginal group (10.5 ± 10.4 h) compared to the oral group (17.2 ± 11.5 h), (p < .0001). Significantly shorter times to delivery were also noted in the vaginal group (17.4 h for vaginal vs. 24.8 h for oral, p < .0001). In the subgroup analysis of nulliparous women, shorter time intervals from the start of induction to attainment of 3-cm dilatation, as well as to delivery, were noted in the vaginal misoprostol group (p < .0001 for both). Multiple linear regression model confirmed route of misoprostol administration as an independent variable in predicting the outcomes (time from start of induction to 3 cm as well as to delivery). Significant findings amongst neonatal outcomes included lower umbilical artery pH and higher rates of neonatal jaundice in the oral misoprostol group.Conclusion: In a population of obese women undergoing induction of labor, vaginal administration of misoprostol was associated shorter time intervals from the start of induction to the attainment of 3 cm of dilatation, as well as to delivery, without increasing the rate of cesarean deliveries or the incidence of adverse maternal and neonatal outcomes.
[Induction of labor by misoprostol, an analog of PGE1. A prospective study of 200 cases]. [2013]We carried out a prospective study of 200 pregnant women who required induction of labor at full term, at the Lalla Meryem maternity unit of the Ibn Rochd University Hospital, Casablanca, between January 1st 1996 and June 30th 1997. The aim of this study was to evaluate the efficacy, tolerance and acceptance of misoprostol (Cytotec) as a drug for inducing labor in unfavorable conditions (Bishop