Patient Empowerment and Agency Through Intrapartum Counseling and Education (PEAICE)

August 1, 2025 updated by: Fei Cai, Oregon Health and Science University

PEAICE: Patient Empowerment and Agency Through Intrapartum Counseling and Education: a Randomized Controlled Study

A single-blind randomized controlled trial to study the effects of a labor guide on perceived control in labor. The experimental arm will receive an evidence-based labor guide at the time of admission for scheduled induction of labor. The control arm will receive the standard of care in-person counseling regarding options for labor interventions

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants will be randomized to receive an evidence-based labor guide at the time of admission for scheduled induction of labor, or the standard of care. Following delivery, patients will be surveyed about their labor experience. Chart review will be done to collect data on obstetric interventions and outcomes and neonatal outcomes.

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Women's Health Research Unit Department of OB/Gyn
  • Phone Number: 503-494-3666
  • Email: whru@ohsu.edu

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Fei Cai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Nulliparous
  • Singleton pregnancy
  • English-speaking
  • Undergoing induction of labor for a medical or elective indication
  • Reached at least 36 weeks 0 days gestation
  • Willing and able to sign a consent form
  • Delivering at OHSU

Exclusion Criteria:

  • Undergoing induction termination
  • Fetal complications such as multiple gestation, major fetal anomalies, fetal demise
  • Decisionally-impaired adults
  • Minors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Participants will receive an evidence-based labor guide at the time of admission for scheduled induction of labor
Other: evidence-based labor guide
Participants will be provided with written education about potential complications and interventions. Information will be provided at the time of admission for labor induction.
No Intervention: Control Group
Participants will receive the standard of care in-person counseling regarding options for labor interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Labor Agentry Scale-10 (LAS-10)
Time Frame: 1-7 days following delivery
A validated questionnaire that measures patient-perceived control during labor
1-7 days following delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Labor Interventions
Time Frame: During labor
Whether patients received labor interventions including Pitocin, misoprostol, cook balloon, intra-uterine pressure catheter, manual rotation
During labor
Maternal hyper/hypotension
Time Frame: During induction of labor
Whether the patient experience hypertension or hypotension
During induction of labor
Intrapartum blood loss
Time Frame: Labor and delivery
The amount of blood loss a patient experienced during delivery
Labor and delivery
Cesarean section
Time Frame: Delivery
Whether a patient requires a cesarean delivery
Delivery
Time to delivery
Time Frame: Admission for induction to delivery
The duration from admission for induction to delivery
Admission for induction to delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Fei Cai, MD, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OHSU IRB 28141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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