204 Participants Needed

Labor Guide for Pregnancy

(PEAICE Trial)

WH
Overseen ByWomen's Health Research Unit Department of Ob/Gyn
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Oregon Health and Science University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how an evidence-based labor guide influences a mother's sense of control during labor. It compares two groups: one using the guide and another receiving standard in-person counseling about labor options. Women expecting their first baby, who are at least 36 weeks pregnant, and planning an induced labor (initiating labor with medical assistance) may be suitable candidates. The trial is not suitable for pregnancies involving multiple babies or other complications. As an unphased trial, it offers a unique opportunity to contribute to enhancing labor experiences for future mothers.

Do I have to stop taking my current medications for the 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.

What prior data suggests that this labor guide is safe for use during pregnancy?

Research has shown that using a well-tested labor guide is generally safe for expecting mothers. Reviews of different methods to start labor, such as oxytocin, indicate they are usually well-tolerated and safe. Oxytocin has proven effective, leading to good outcomes for both mothers and babies.

Studies on methods like vaginal misoprostol have found they can reduce the likelihood of needing a cesarean section. These methods are not only effective but also carry a low risk of major complications.

Overall, these guides are based on safe and effective practices, suggesting they are likely to be well-tolerated with minimal side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the Evidence-Based Labor Guide because it offers a structured, data-driven approach to labor management, unlike traditional methods that rely on standard in-person counseling. This guide provides personalized, evidence-based recommendations at the time of admission for labor induction, potentially enhancing decision-making for both patients and healthcare providers. By focusing on real-time, individualized guidance, this approach aims to improve outcomes and empower expectant mothers with more control over their birth experience.

What evidence suggests that this labor guide is effective for improving perceived control in labor?

Research has shown that guides based on solid evidence can greatly improve the labor experience. In this trial, participants in the experimental group will receive an evidence-based labor guide, which studies indicate can increase the likelihood of a vaginal birth. For example, 82% of women had a successful vaginal delivery after labor was induced using methods similar to those in these guides. Additionally, well-tested methods, such as balloon catheters, ensure both safety and effectiveness. These guides offer clear and practical information, helping women feel more in control and confident during labor.12456

Who Is on the Research Team?

FC

Fei Cai, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for first-time mothers with a single baby, who speak English and are at least 36 weeks pregnant. They must be willing to sign consent and be delivering at OHSU while undergoing labor induction for medical or elective reasons.

Inclusion Criteria

I speak English.
I have never given birth.
I am pregnant with one baby.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either an evidence-based labor guide or standard in-person counseling at the time of admission for scheduled induction of labor

Admission to delivery
1 visit (in-person)

Follow-up

Participants are surveyed about their labor experience and chart review is conducted to collect data on obstetric interventions and outcomes

1-7 days following delivery

What Are the Treatments Tested in This Trial?

Interventions

  • Evidence-Based Labor Guide
Trial Overview The study compares the effects of an evidence-based labor guide given upon admission for scheduled labor induction versus standard in-person counseling. It's designed to see if the guide helps women feel more in control during childbirth.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental GroupExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials
1,024
Recruited
7,420,000+

Citations

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 ...
Evidence on: Inducing for Due DatesIn the expectant management group, 74% of the participants went into labor spontaneously before their planned induction and 26% were induced. Interestingly, the ...
Methods for the induction of labor: efficacy and safetyA meta-analysis of the first 8 trials found that labor induction with vaginal misoprostol significantly reduced the incidence of cesarean ...
Safety and effectiveness of different modes of labor induction ...The results showed that 82% of women achieved SVD after labor induction, highlighting the overall effectiveness of these methods in promoting ...
How labor induction methods have evolved throughout ...High-quality evidence shows that balloon catheters are one of the most effective and safest methods, especially in the outpatient setting or when concerned ...
6.evidencebasedbirth.comevidencebasedbirth.com/arrive/
The ARRIVE Trial and Elective Induction at 39 WeeksImpact on newborn outcomes​​ The ARRIVE trial researchers found that electively inducing labor at 39 weeks had no impact on the primary composite ...
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