Misoprostol Dosing in BMI Greater Than 30

(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

180 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if a higher dose of a labor-inducing medication can speed up delivery in obese women. Obese women often face longer and more complicated labors. The medication helps prepare the cervix for labor, potentially making delivery faster.

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 data supports the effectiveness of the drug Misoprostol (Cytotec)?

Research shows that Misoprostol is effective in treating severe bleeding after childbirth and in managing early pregnancy failures, such as incomplete abortions. It helps the uterus contract, which can stop bleeding and help clear the uterus. ^{1 2 3 4 5}

What safety data exists for Misoprostol (Cytotec) regarding its general safety in humans?

The available research does not provide specific safety data for Misoprostol (Cytotec) in humans, but it highlights the importance of monitoring for adverse drug reactions and the role of pharmacovigilance programs in identifying potential risks associated with medications. ^{6 7 8 9 10}

How is the drug Misoprostol unique compared to other treatments for its condition?

Misoprostol is unique because it is a prostaglandin E1 analogue that is used off-label for various gynecological purposes, such as inducing labor and managing miscarriages, due to its low cost and high efficacy. Unlike other treatments, it can be administered orally, vaginally, or rectally, making it versatile in its application. ^{1 11 12 13 14}

Research Team

Lorie Harper, MD, MSCI

Principal Investigator

Division Chief, Maternal-Fetal Medicine

Eligibility Criteria

Inclusion Criteria

You are pregnant with one baby.

Age 18 years or older

Gestational age >= 36 weeks

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

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

Treatment Details

Interventions

• Misoprostol

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Rectal administration of misoprostol for delivery induced hemorrhage. Preliminary study]. [2013]

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

Medical treatment with misoprostol for early failure of pregnancies after assisted reproductive technology: a promising treatment option. [2013]

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

Clinical indicators for success of misoprostol treatment after early pregnancy failure. [2019]

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

Two regimens of misoprostol for treatment of incomplete abortion. [2013]

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

Comparative study between single dose 600 microg and repeated dose of oral misoprostol for treatment of incomplete abortion. [2013]

6. Colombia pubmed.ncbi.nlm.nih.gov

[Adverse drug reactions in neonates hospitalized in neonatal intensive care units in Barranquilla, Colombia]. [2018]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The role of the New Zealand Intensive Medicines Monitoring Programme in identification of previously unrecognised signals of adverse drug reactions. [2019]

8. United States 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. [2018]

9. France pubmed.ncbi.nlm.nih.gov

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

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

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. [2023]

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

Instability of misoprostol tablets stored outside the blister: a potential serious concern for clinical outcome in medical abortion. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Vaginal misoprostol for cervical ripening and induction of labour. [2023]

13. Bulgaria pubmed.ncbi.nlm.nih.gov

[Misoprostol and induction of labour]. [2013]

14. England pubmed.ncbi.nlm.nih.gov

Vaginal misoprostol for cervical ripening and induction of labour. [2020]