Misoprostol for Labor Induction in Obese Pregnant Women

Overseen By Rosa Drummond, MD

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Maryland, Baltimore

Disqualifiers: Cesarean history, Placenta previa, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Until delivery

162 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{2 3 6 7 8}

How 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. ^{2 3 4 9 10}

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.

Eligibility 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

Contractions < 5 per 10 minutes

I am morbidly obese with a BMI of 40 or higher.

I am pregnant with one baby in the head-down position.

Exclusion Criteria

History of cesarean delivery

Fetal growth restriction with abnormal umbilical artery Doppler indices

Contractions >5 per 10 minutes

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

Treatment Details

Interventions

• Misoprostol

Trial Overview 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.

Participant Groups

Group I: Intervention - 50 mcg vaginal misoprostol Experimental Treatment 1 Intervention

Participants will receive 50 mcg vaginal misoprostol every 4 hours.

Group II: Control - 25 mcg vaginal misoprostol Active Control 1 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

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Findings from Research

In a study of 329 women undergoing labor induction with misoprostol, higher body mass index (BMI) was associated with a significantly longer time to delivery and an increased need for more doses of misoprostol.

Women with higher BMIs also experienced longer durations of oxytocin administration and had a higher risk of cesarean delivery, indicating that obesity can complicate the induction process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of labor with an unfavorable cervix: how does BMI affect success? (‡). Lassiter, JR., Holliday, N., Lewis, DF., et al.[2022]

Misoprostol is shown to be safe and effective for inducing labor, outperforming oxytocin and vaginal prostaglandin E2 in achieving vaginal delivery within 24 hours, based on over 45 randomized trials involving more than 5400 women.

While there are no significant differences in serious adverse outcomes between low-dose misoprostol and other methods, its use should be carefully monitored, and the recommended dosage is 25 mcg vaginally every 4 to 6 hours for selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of labor: the misoprostol controversy. Goldberg, AB., Wing, DA.[2019]

In a study of 206 obese pregnant women, the misoprostol vaginal insert (MVI) was found to be an effective labor induction agent, showing a cesarean section rate of 29.8% in high-risk pregnancies, which is comparable to 23.5% in non-high-risk pregnancies, indicating similar safety profiles.

The time from drug administration to delivery was significantly shorter in high-risk pregnancies (16.9 hours) compared to non-high-risk pregnancies (19.4 hours), suggesting that MVI may facilitate quicker labor induction in obese women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Misoprostol Vaginal Insert Safe for the Induction of Labor in High-Risk Pregnancy Obese Women? Varlas, VN., Bostan, G., Nasui, BA., et al.[2021]

In a study of 1637 pregnant women, it was found that the cumulative dose of Misoprostol required for labor induction significantly increased with higher body mass index (BMI), indicating that obese women may need more medication for effective induction.

Despite the increased dose and longer time to delivery associated with higher BMI, 76% of women with obesity successfully achieved vaginal delivery, and there were no significant differences in neonatal outcomes or maternal mortality rates across BMI classes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's body mass index and oral administration of Misoprostol for induction of labor - A retrospective cohort study. Helmig, RB., Brogaard, L., Hvidman, L.[2022]

In a study of 564 obese women undergoing induction of labor, misoprostol was found to be more effective than dinoprostone, achieving a higher successful cervical ripening rate (78.1% vs. 66.7%) and a lower cesarean delivery rate (39.1% vs. 51.3%).

Both medications had similar rates of peripartum complications and neonatal outcomes, indicating that while misoprostol is more effective, it does not increase risks for mothers or babies compared to dinoprostone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Labor outcomes of obese patients undergoing induction of labor with misoprostol compared to dinoprostone. Suidan, RS., Rondon, KC., Apuzzio, JJ., et al.[2018]

The off-label use of Cytotec (misoprostol) for inducing labor has become more common, raising concerns about the safety and evidence behind such medical interventions during childbirth.

The article highlights two cases of unnecessary maternal and infant deaths linked to questionable medical practices, emphasizing the need for evidence-based approaches in childbirth to reduce morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The freedom to birth-the use of cytotec to induce labor: a non-evidence-based intervention. Oden, M., Certificate, D.[2021]

The FDA approved a new label for Cytotec (misoprostol) on April 17, 2002, but it does not provide claims about its efficacy or safety for cervical ripening during labor induction.

The Committee on Obstetric Practice advises that Cytotec should continue to be used according to previous recommendations, as the new labeling does not specify dosing or intervals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACOG committe opinion. New U.S. Food and Drug Administration labeling on Cytotec (misoprostol) use and pregnancy. Number 283, May 2003. [2019]

The FDA approved a new label for Cytotec (misoprostol) on April 17, 2002, but it does not provide claims about its efficacy or safety for cervical ripening during labor induction.

Healthcare providers are advised to continue using Cytotec according to previous recommendations, as the new labeling does not specify dosing or intervals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACOG Committee Opinion. Number 283, May 2003. New U.S. Food and Drug Administration labeling on Cytotec (misoprostol) use and pregnancy. [2019]

In a study of 1,280 obese women undergoing labor induction, vaginal misoprostol was found to be significantly more effective than oral misoprostol, resulting in shorter times to reach 3 cm cervical dilation (10.5 hours vs. 17.2 hours) and to delivery (17.4 hours vs. 24.8 hours).

The use of vaginal misoprostol did not increase the rate of cesarean deliveries or adverse maternal and neonatal outcomes, suggesting it is a safe and effective option for cervical ripening in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is vaginal misoprostol more effective than oral misoprostol for cervical ripening in obese women? Soni, S., Pappas, K., Lesser, ML., et al.[2021]

In a study of 200 pregnant women, misoprostol was found to be highly effective for inducing labor in unfavorable conditions, with a failure rate of only 5% and a mean delivery time of 13.3 hours after administration.

The use of misoprostol was well tolerated, with a low incidence of uterine hyperstimulation (3.5%) and a cesarean section rate of 22%, indicating it is a safe option for labor induction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Induction of labor by misoprostol, an analog of PGE1. A prospective study of 200 cases]. Chraibi, T., Aboulfalah, A., Bisbis, W., et al.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Induction of labor with an unfavorable cervix: how does BMI affect success? (‡). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Induction of labor: the misoprostol controversy. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Is Misoprostol Vaginal Insert Safe for the Induction of Labor in High-Risk Pregnancy Obese Women? [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Women's body mass index and oral administration of Misoprostol for induction of labor - A retrospective cohort study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Labor outcomes of obese patients undergoing induction of labor with misoprostol compared to dinoprostone. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

The freedom to birth-the use of cytotec to induce labor: a non-evidence-based intervention. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

ACOG committe opinion. New U.S. Food and Drug Administration labeling on Cytotec (misoprostol) use and pregnancy. Number 283, May 2003. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

ACOG Committee Opinion. Number 283, May 2003. New U.S. Food and Drug Administration labeling on Cytotec (misoprostol) use and pregnancy. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Is vaginal misoprostol more effective than oral misoprostol for cervical ripening in obese women? [2021]

10. France pubmed.ncbi.nlm.nih.gov

[Induction of labor by misoprostol, an analog of PGE1. A prospective study of 200 cases]. [2013]