Medications to Induce Labor for Childbirth

(BLOOM Trial)

Recruiting at 2 trial locations

Overseen By Allison Perelman, MD

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: BMI < 30

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: From start of induction until delivery

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two common methods to induce labor in individuals with a high BMI (body mass index) of 30 or more. Researchers aim to determine whether misoprostol (also known as Cytotec) or pitocin (also known as Oxytocin, Syntocinon, or Viatocinon), both used with a foley catheter (a small tube inserted to help open the cervix), is more effective for inducing labor. Participants will receive either pitocin alone or a combination of misoprostol and pitocin. This trial may suit those who are pregnant, planning to be induced, and have a BMI of 30 or higher. As a Phase 3 trial, it represents the final step before FDA approval, offering a chance to contribute to important research on labor induction methods.

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.

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

Research shows that misoprostol is generally safe for starting labor. Studies indicate it doesn't significantly harm newborns and can even reduce the need for a C-section. It has been tested in various situations and found effective. However, some studies noted a higher chance of stopping labor induction with misoprostol.

Pitocin, also known as oxytocin, has FDA approval to assist with labor. It is widely used and helps many women have vaginal births. However, if labor takes too long, there is a risk of increased bleeding. Overall, previous research has shown that both misoprostol and pitocin are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for inducing labor because they explore different approaches with Misoprostol and Pitocin. Unlike using Pitocin alone, which is a synthetic form of oxytocin traditionally used to stimulate contractions, the combination with Misoprostol offers a fresh angle. Misoprostol is a prostaglandin that helps ripen the cervix and initiate labor, potentially making the process more efficient when used together with Pitocin. This dual approach could lead to faster and more effective labor induction, offering new possibilities for expectant mothers.

What evidence suggests that this trial's treatments could be effective for inducing labor in patients with obesity?

This trial will compare different methods for inducing labor. Research has shown that a combination of misoprostol and a Foley catheter, which participants in one arm of this trial may receive, effectively starts labor and can significantly shorten the time to birth. Misoprostol initiates labor faster than other methods.

In another arm of this trial, participants will receive Pitocin, a synthetic form of the hormone oxytocin, which is also effective on its own. Studies found that 95% of women who used Pitocin had a natural vaginal delivery. Pitocin works especially well when the cervix is slightly open and the mother has a lower body mass index. Both treatments can successfully induce labor, but their effectiveness may vary based on individual circumstances. ^{2 4 6 7 8}

Who Is on the Research Team?

Angela Bianco, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Nicola F Tavella, MPH

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for pregnant individuals with a BMI of 30 or higher who are going to the hospital to start labor. It's not for those with a BMI under 30.

Inclusion Criteria

I am pregnant, have a BMI of 30 or more, and am going to be induced.

Exclusion Criteria

I am pregnant, going into labor, and my BMI is under 30.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to receive either misoprostol or pitocin, in combination with a foley catheter, to induce labor

From start of induction until delivery

Follow-up

Participants are monitored for delivery outcomes, including whether delivery was vaginal or cesarean

At delivery

What Are the Treatments Tested in This Trial?

Interventions

• Misoprostol
• Pitocin

Trial Overview The study is testing if using Misoprostol and Pitocin together, along with a foley catheter, is better at starting labor compared to just Pitocin and the catheter in patients considered obese.

How Is the Trial Designed?

Group I: Pitocin only Active Control 1 Intervention

Patient receives pitocin and foley catheter for initial induction of labor, followed by more pitocin later on.

Group II: Misoprostol and Pitocin Active Control 2 Interventions

Patient receives misoprostol and foley catheter for initial induction of labor, followed by pitocin later on.

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?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Bronx Care Health System

Collaborator

Trials

1

Recruited

300+

Published Research Related to This Trial

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]

In a study of 77 pregnant women, titrated oral misoprostol was found to be highly effective for labor induction, with 93.5% achieving vaginal delivery within 24 hours and an average delivery time of 9.7 hours after induction.

The method demonstrated safety, as there were no cases of uterine hyperstimulation or induction failure, although 9.1% experienced uterine tachysystole, indicating that the dosage can be tailored to individual responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of labor induction with titrated oral misoprostol. Cheng, SY., Chen, TC.[2013]

In a study of 276 patients, intravaginal Cytotec resulted in a shorter average time from induction to vaginal delivery (approximately 22 hours) compared to Oxytocin (approximately 25 hours).

Both Cytotec and Oxytocin showed similar rates of abdominal delivery, indicating that Cytotec is as effective as Oxytocin for labor induction without significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cytotec: an effective drug for the induction of labor]. Milchev, N., Kuzmanov, B., Terzhumanov, R.[2013]

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]

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]

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]

Mechanical and biochemical methods for inducing labor have been widely used in obstetrics, with new uterotonic agents like mifepristone and misoprostol offering convenient oral administration options.

These newer agents can be managed in outpatient settings, potentially improving accessibility and patient comfort during the labor induction process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of labor. Reichler, A., Romem, Y., Divon, MY.[2004]

Vaginally administered misoprostol is as effective as dinoprostone for cervical ripening and labor induction, with similar mean time intervals to delivery and need for oxytocin augmentation in a study of 200 patients.

However, misoprostol was associated with a significantly lower incidence of tachysystole (7.1% vs. 18.4% for dinoprostone), indicating a potentially safer profile regarding uterine contractions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of intermittent vaginal administration of misoprostol with continuous dinoprostone for cervical ripening and labor induction. Wing, DA., Ortiz-Omphroy, G., Paul, RH.[2019]

In a study of 38 women with an unfavorable cervix, intravaginal misoprostol was found to significantly improve cervical readiness for labor compared to the standard treatment with PGE2 and oxytocin, with a median change in Bishop score of 4 versus 1 (P < 0.001).

Misoprostol also led to a higher rate of delivery within 36 hours (88% vs. 47%, P = 0.01), although it was associated with a higher incidence of tachysystole (8 cases vs. 0 in the control group, P < 0.01), indicating a need for monitoring for this side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Misoprostol as a labor induction agent. Magtibay, PM., Ramin, KD., Harris, DY., et al.[2013]

In a study of 200 patients requiring labor induction, oral misoprostol was found to be equally effective as the combination of a Foley catheter and oxytocin for inducing labor in multiparous women.

However, in nulliparous women, misoprostol resulted in significantly lower rates of delivery within 24 hours and longer median induction-to-delivery times, indicating it may be less effective for first-time mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized comparison of oral misoprostol versus Foley catheter and oxytocin for induction of labor at term. Abramovici, D., Goldwasser, S., Mabie, BC., et al.[2019]

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]

In low-income countries, up to 50% of hospital deliveries involve the use of oxytocin and misoprostol for labor induction and augmentation, highlighting their widespread application.

However, there are potential risks associated with these medications, including stillbirth, neonatal resuscitation needs, and uterine rupture, indicating a critical need for improved guidelines and community awareness regarding their safe use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to avoid iatrogenic morbidity and mortality while increasing availability of oxytocin and misoprostol for PPH prevention? Lovold, A., Stanton, C., Armbruster, D.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5433665/

Outcome of misoprostol and oxytocin in induction of labour The main aim of this study is to find out the maternal and foetal outcomes after induction of labour with misoprostol and oxytocin beyond 37 weeks of gestation.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538944/

Misoprostol for Cervical Ripening and Induction of Labour This review aims to review the clinical effectiveness, cost-effectiveness, and evidence-based guidelines regarding the use of misoprostol for cervical ripening ...

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

Methods for the induction of labor: efficacy and safety A meta-analysis of the first 8 trials found that labor induction with vaginal misoprostol significantly reduced the incidence of cesarean ...

4. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07592-2

Efficacy and safety of misoprostol versus oxytocin for labor ... The findings of our meta-analysis suggested that misoprostol was associated with significantly shorter induction to delivery interval and ...

5. aafp.org aafp.org/pubs/afp/issues/2022/0200/p177.html

Cervical Ripening and Induction of Labor Combining a balloon catheter with misoprostol is a common practice and has been shown to decrease time to delivery in a small study.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5591556/

Safety and effectiveness of oral misoprostol for induction ... The oral misoprostol regimen for IOL described in the present study is safe, effective and logistically feasible to administer in a resource-limited setting.

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

A retrospective cohort study of delivery outcomes after use of ... Outpatient misoprostol was associated with increased adjusted odds of canceling an induction due to labor (odds ratio [OR] 2.47; 95% confidence ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12051426/

Comparison of the Safety and Effectiveness of Labor ... Both dosing regimens of oral misoprostol were effective for labor induction, but the 50 μg dose was associated with a shorter induction‐to‐delivery time.