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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which dose of Misoprostol, a medicine used to induce labor, is more effective for very overweight pregnant women (those with a BMI over 40). Researchers aim to increase the chances of vaginal delivery and reduce the need for C-sections, which can lead to more complications. The trial compares two doses: 25 mcg and 50 mcg, administered every 4 hours. Women who are morbidly obese, pregnant with one baby, and not yet experiencing frequent contractions might be suitable candidates for this study. As an Early Phase 1 trial, this research focuses on understanding how Misoprostol works in people, offering participants a chance to contribute to groundbreaking insights.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Misoprostol is generally well-tolerated for inducing labor in pregnant women who are obese. Studies have found that both oral and vaginal administration of Misoprostol can effectively induce labor in women with obesity and other conditions like high blood pressure or diabetes.

Safety information for vaginal Misoprostol suggests it might shorten the time to delivery, which can be beneficial for initiating labor. However, limited safety data exists for its use in high-risk pregnancies, especially in obese women.

This treatment is in the earliest phase of clinical trials, so researchers are still collecting safety information in humans. While Misoprostol is commonly used to induce labor, ongoing research is crucial to confirm its safety and effectiveness, particularly for women with a BMI over 40. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using misoprostol for labor induction in obese pregnant women because it offers a potentially more effective approach compared to current methods like oxytocin or cervical ripening balloons. Misoprostol works by directly stimulating uterine contractions and softening the cervix, which may lead to a more efficient induction process. This trial explores two dosages: 50 mcg and 25 mcg administered vaginally every four hours, allowing researchers to evaluate not only the effectiveness but also the safety and optimal dosing for this specific population. This could lead to a more tailored and effective induction process, addressing the unique needs of obese pregnant women.

What evidence suggests that Misoprostol might be an effective treatment for labor induction in obese pregnant women?

Research has shown that misoprostol effectively initiates labor, particularly in women with obesity. One study found that vaginal use of misoprostol can shorten the time to birth. Another study demonstrated that misoprostol helps the cervix soften and open, potentially reducing the need for a cesarean section. In this trial, participants will receive either a 50 mcg dose or a 25 mcg dose of vaginal misoprostol. For women with obesity, higher doses like 50 mcg may expedite the process from labor onset to delivery compared to lower doses. Misoprostol also proves effective for women with conditions such as high blood pressure or diabetes. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

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

Cervical dilation >5 cm

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34503935/

Women's body mass index and oral administration of ... In this study, we found the total dose of Misoprostol needed for induction increased significantly with increasing BMI (p < 0.005).

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24915563/

Labor outcomes of obese patients undergoing induction ... Conclusion: In obese women undergoing IOL, misoprostol leads to a higher successful cervical ripening rate and a lower CD rate than dinoprostone, with a similar ...

3. journals.lww.com journals.lww.com/greenjournal/abstract/2016/05001/vaginal_versus_oral_administration_of_misoprostol.336.aspx

Vaginal Versus Oral Administration of Misoprostol for Labor ... CONCLUSION: In labor induction among obese women, vaginal administration of misoprostol may be associated with decreased time to delivery.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937824000747

Optimal misoprostol dosing among patients with a body ... This study aimed to determine if 50 μg compared with 25 μg of vaginal misoprostol reduced the time from induction start to delivery among patients with obesity.

5. tandfonline.com tandfonline.com/doi/full/10.1080/14767058.2024.2327573

Full article: Efficacy and safety of oral and vaginal ... Conclusion. Misoprostol administration, both orally and vaginally, proves effective for labor induction in obese pregnant women with hypertension or diabetes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8070889/

Is Misoprostol Vaginal Insert Safe for the Induction of Labor ... 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 ...

7. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.70373

A retrospective cohort study of delivery outcomes after use of ... Rather, we found that it increased the likelihood of spontaneous labor and was associated with higher birth weight and greater gestational age.