Misoprostol vs Oxytocin for Induction of Labor

(PROMMO Trial)

Overseen By Jacquelyn Adams, MD

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: University of Wisconsin, Madison

Must not be taking: Anticoagulants

Disqualifiers: Intra-amniotic infection, Previous cesarean, others

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

Compensation: Varies

Number of Visits: 6

Duration: Up to 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine the best method to induce labor for women whose water has broken early and whose cervix is not yet ready for labor. It compares two methods: administering oxytocin through an IV and taking misoprostol orally. Women who may qualify for this trial are those near or at full term, whose water has broken, and whose cervix is not fully prepared for birth. As an Early Phase 1 trial, this research seeks to understand how these treatments work in people, offering participants an opportunity to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulants (blood thinners), you should not have taken them within 24 hours of delivery.

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

Studies have shown that intravenous oxytocin effectively and safely initiates labor, leading to positive outcomes for both mothers and babies. Research indicates that oxytocin facilitates vaginal delivery within 24 hours, making it a reliable option for labor induction.

Research also suggests that oral misoprostol is a safe method for starting labor. Most women who used it experienced vaginal deliveries, with favorable results for both mother and baby. The 50 microgram dose effectively reduces the time from labor initiation to delivery.

Previous studies have demonstrated the safety of both treatments, with no major concerns about serious side effects when used to start labor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using oral misoprostol for inducing labor because, unlike the standard intravenous oxytocin, which requires hospital equipment and monitoring, misoprostol can be taken orally, offering more flexibility. Misoprostol also provides a different approach by potentially allowing labor to progress with fewer medical interventions due to its oral administration. This could lead to a more accessible and potentially less invasive option for labor induction compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for labor induction?

This trial will compare the effectiveness of intravenous oxytocin and oral misoprostol for inducing labor. Studies have shown that administering oxytocin through an IV helps women deliver vaginally within 24 hours, significantly increasing the chances compared to waiting without treatment. Research also indicates that oxytocin reduces the risk of heavy bleeding after birth. Meanwhile, oral misoprostol effectively initiates labor, performing as well as the vaginal form of the drug, and leads to shorter times from labor onset to delivery. Both treatments have strong evidence supporting their ability to effectively start labor. ^{1 3 6 7 8}

Who Is on the Research Team?

Jacquelyn Adams, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

The PROMMO Trial is for pregnant women over 18 with a single baby, between 34 and less than 42 weeks along, who have had their water break before labor starts and an unfavorable cervix for delivery. Women must not have had a previous C-section, bleeding disorders like von Willebrand's or hemophilia, recent anticoagulants use, or infection concerns.

Inclusion Criteria

Early Term to late term pregnancy (>37 weeks and 0 days and <42 weeks and 0 days)

Confirmed rupture of membranes by either sterile speculum exam or AmniSure

I am in my late preterm pregnancy stage (34-36 weeks).

Exclusion Criteria

The pregnancy cannot be accurately dated.

There is a worry about an infection inside the womb.

I received blood thinners within a day after giving birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral misoprostol or intravenous oxytocin for labor induction

Up to 72 hours

In-hospital stay for labor and delivery

Immediate Postpartum

Monitoring for postpartum hemorrhage and initial maternal and neonatal health assessments

Up to 24 hours

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction after delivery

6 weeks

Postpartum day one visit, follow-up at 6 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Intravenous Oxytocin
• Misoprostol Oral Product

Trial Overview This study compares two ways to start labor when the water breaks early: swallowing Misoprostol pills versus getting Oxytocin through an IV. It aims to find out which method works best for women with a low Bishop score indicating the cervix isn't ready for birth.

How Is the Trial Designed?

Group I: intravenous oxytocin Active Control 1 Intervention

At time of delivery, participants randomly assigned to intravenous oxytocin, will be administered the drug per standard of labor and delivery titrations.

Group II: oral misoprostol Active Control 1 Intervention

At time of delivery, participants randomly assigned to either oral misoprostol will receive 50 mcg of Misoprostol every 4 hours up to 6 doses, OR until simplified Bishop score \>6 (whichever is achieved first).

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4164045/

Intravenous oxytocin alone for cervical ripening and induction ... Intravenous oxytocin reduced the failure to achieve vaginal delivery within 24 hours when compared with expectant management (8.4% versus 54%, risk ratio (RR) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8363560/

Review of Evidence-Based Methods for Successful Labor ... This article provides a review of the current research evidence on labor induction methods, including cervical ripening techniques and contraction stimulation ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933325000916

High- vs low-dose oxytocin protocols for labor induction: a ... Induction with high-dose oxytocin was associated with a lower frequency of postpartum hemorrhage, compared with a low-dose protocol (7.6% vs 9.9%, RR 0.78, 95% ...

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

Methods for the induction of labor: efficacy and safety The authors found that patients receiving oxytocin were less likely not to deliver vaginally within 24 hours than those receiving expectant ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00957593

NCT00957593 | Induction of Labor With Oxytocin: When ... The primary outcome will be the rate of cesarean delivery between the groups. Secondary outcomes to be evaluated will include duration of the labor, fetal heart ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11792443/

Safety and effectiveness of different modes of labor ... Oxytocin was the most effective and safest method for labor induction within 24 h, resulting in favorable maternal and neonatal outcomes.

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

Efficacy and safety of misoprostol versus oxytocin for labor ... Overall, the use of misoprostol for labor induction appears to be safe for neonatal outcomes, with no significant differences in key metrics ...

8. ahrq.gov ahrq.gov/patient-safety/settings/labor-delivery/perinatal-care/modules/strategies/medication/tool-safe-oxytocin.html

Safe Medication Administration: Oxytocin Purpose of the tool: This tool describes the key perinatal safety elements with examples for the safe administration of oxytocin during labor.