Misoprostol for Inducing Labor in Obese Pregnant Women

(MD30 RCT Trial)

Overseen By Elizabeth Davis

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Texas at Austin

Disqualifiers: Multiple gestations, Prior cesarean, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: Until delivery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a higher dose of vaginal misoprostol can shorten the time to delivery in obese women undergoing induction. Misoprostol helps prepare the cervix for labor. Participants will be divided into two groups: one receiving 50 micrograms and the other 25 micrograms every four hours. Women who are at least 36 weeks pregnant, have a BMI of 30 or higher, and plan to undergo cervical ripening may be suitable for this study. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

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 doctor.

What is the safety track record for Misoprostol?

Research shows that using a low dose of vaginal misoprostol, such as 25 micrograms, is generally safe and effective for inducing labor in full-term pregnancies. Studies have found that this dose is well-tolerated by women who have not previously had a C-section. However, misoprostol can pose risks, especially at higher doses or in certain situations. These risks include uterine rupture, where the womb tears, and other potential complications during pregnancy.

It is important to note that the FDA has not approved misoprostol specifically for labor induction, meaning its safety for this purpose has not been officially reviewed and accepted. Prospective trial participants should consult medical professionals for advice tailored to their individual health needs. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because they explore different dosing regimens of vaginal misoprostol for cervical ripening in women with a BMI greater than 30. Misoprostol is already used in this context, but this trial tests whether a higher dose of 50 micrograms is more effective than the standard 25 micrograms. By comparing these doses, researchers hope to determine the optimal amount that balances efficacy and safety, potentially improving outcomes for women undergoing labor induction.

What evidence suggests that this trial's treatments could be effective for reducing the time from induction start to delivery in obese women?

Research has shown that vaginal misoprostol effectively initiates labor. In this trial, participants will receive either a 50 microgram dose or a 25 microgram dose of vaginal misoprostol through randomization. Studies have found that a 50 microgram dose most likely results in a vaginal birth within 24 hours, thereby speeding up labor. However, higher doses can cause the uterus to contract too often, a condition known as uterine hyperstimulation. A 25 microgram dose is also effective, though it may take slightly longer. Both doses reduce the need for a cesarean section compared to some other treatments. ^{6 7 8 9 10}

Who Is on the Research Team?

Lorie Harper, MD, MSCI

Principal Investigator

Division Chief, Maternal-Fetal Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

You are pregnant with one baby.

Gestational age >= 36 weeks

Cervical dilation <= 3cm

Exclusion Criteria

Contraindication to vaginal delivery (placenta previa, vasa previa, prior classical cesarean, non-vertex presentation, etc.)

Non-reassuring fetal heart tracing

Evidence of clinical chorioamnionitis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 25 mcg or 50 mcg of vaginal misoprostol every 4 hours for cervical ripening

Until delivery

Continuous monitoring during labor and delivery

Follow-up

Participants and their infants are monitored for safety and effectiveness until discharge

Up to 5 days post-delivery

Daily assessments postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Misoprostol

How Is the Trial Designed?

Group I: 50 Micrograms Vaginal Misoprostol (Intervention) Experimental Treatment 1 Intervention

Subjects in this arm will be randomized to the 50 micrograms of vaginal misoprostol (intervention) group, they will be admitted to labor and delivery and undergo placement of 50 micrograms of intravaginal misoprostol every 4 hours for cervical ripening.

Group II: 25 Micrograms Vaginal Misoprostol (Control) Active Control 1 Intervention

Subjects in this arm will be randomized to the 25 micrograms of vaginal misoprostol (control) group, they will be admitted to labor and delivery and undergo placement of 25 micrograms of intravaginal misoprostol every 4 hours for cervical ripening.

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 Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Published Research Related to This Trial

In a study involving five patients with severe delivery-induced hemorrhage due to uterine atony unresponsive to syntocinon, rectal administration of one misoprostol tablet effectively stopped the bleeding in less than 5 minutes for all patients.

No immediate side effects were observed, suggesting that misoprostol may be a safe and rapid intervention for managing severe hemorrhage in this context, warranting further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rectal administration of misoprostol for delivery induced hemorrhage. Preliminary study]. Shojai, R., Piéchon, L., d'Ercole, C., et al.[2013]

Vaginal misoprostol is effective for cervical ripening and labor induction, significantly reducing the failure to achieve vaginal delivery within 24 hours compared to placebo, with a relative risk of 0.51 based on 121 trials.

While misoprostol is more effective than conventional methods, it is associated with a higher risk of uterine hyperstimulation, particularly at doses above 25 mcg every four hours, indicating a need for careful dosing and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal misoprostol for cervical ripening and induction of labour. Hofmeyr, GJ., Gülmezoglu, AM., Pileggi, C.[2023]

From 2004 to 2016, only 166 adverse events related to baby personal care products were reported to the FDA, with most cases involving skin reactions like rashes, and nearly half of these incidents required a healthcare visit.

The study highlights the need for pediatric dermatologists to actively report adverse events and encourage consumers to do the same, as current reporting is low and may not fully capture the safety concerns associated with these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants. Cornell, E., Kwa, M., Paller, AS., et al.[2018]

The 22nd French pharmacovigilance meeting revealed 315 notifications of severe adverse effects linked to non-specific 'immunostimulants', with 68% of cases considered likely attributable to the drugs, including three fatalities.

The meeting highlighted that many adverse effects, both known and rare, continue to occur with various medications, emphasizing the need for better documentation and monitoring of drug safety, as well as the potential for immediate market withdrawal of drugs with poor risk-benefit ratios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Highlights of the 22nd French pharmacovigilance meeting. [2007]

Between 2010 and 2016, 164 safety advisories regarding cardiac-related adverse events were issued by regulators in Australia, Canada, the UK, and the US, highlighting the prevalence of risks associated with 61 different drugs, primarily involving cardiac arrhythmias and coronary artery disorders.

While monitoring patients was the most common recommendation in these advisories, only 41.2% provided detailed guidance on how to conduct this monitoring, indicating a need for more consistent and comprehensive information for healthcare professionals and consumers regarding rare but serious medication harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. Hooimeyer, A., Bhasale, A., Perry, L., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7061246/

Vaginal misoprostol for cervical ripening and induction of labour Vaginal misoprostol in doses above 25 mcg four‐hourly was more effective than conventional methods of labour induction, but with more uterine hyperstimulation.

2. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-023-01007-8

Comparison of the effect of oral and vaginal misoprostol on ... According to the results of this study, vaginal use of misoprostol can induce labor faster and puts childbirth ahead by an average of 24 min (0 ...

3. ajog.org ajog.org/article/S0002-9378(23)00081-9/fulltext

Methods for the induction of labor: efficacy and safety Misoprostol administered vaginally at doses of 50 μg has the highest probability of achieving vaginal delivery within 24 hours.

4. reports.mountsinai.org reports.mountsinai.org/article/obgyn2024-_7_cervical

Low-Dose Vaginal Misoprostol in Cervical Ripening Is ... Across the methods studied, the researchers found that 25 μg of vaginal misoprostol was most effective in reducing the time from intervention to delivery.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211523008060

Effect of misoprostol versus oxytocin on delivery outcomes ... Meta-analysis revealed that vaginal misoprostol administration, compared with oxytocin, resulted in a significant reduction in the rate of cesarean.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK539873/

Misoprostol - StatPearls - NCBI Bookshelf - NIH Misoprostol use in pregnant women has been associated with premature birth, congenital abnormalities, and abortion. · A risk of uterine rupture ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/019268s051lbl.pdf

Cytotec® misoprostol tablets WARNINGS ... CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE. PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, PREMATURE BIRTH. OR UTERINE RUPTURE. UTERINE RUPTURE HAS BEEN ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16752263/

Effectiveness and safety of a new vaginal misoprostol ... Conclusion: The results showed that the 25-microg vaginal tablets of misoprostol were as effective and safe for cervical ripening and labor induction as the ...

9. nature.com nature.com/articles/s41598-025-86422-z

A disproportionality analysis of FDA adverse event ... Oral misoprostol was a safe choice for term prelabor rupture of the membranes (TPROM) induction, and the occurrence of adverse reactions could ...

10. aafp.org aafp.org/pubs/afp/issues/2006/0201/p511.html

Vaginal Misoprostol for Cervical Ripening in Term Pregnancy Low-dose (25 mcg) intravaginal misoprostol appears to be safe and effective for cervical ripening in term pregnancy for patients without a history of cesarean ...