Patient Empowerment and Agency Through Intrapartum Counseling and Education

NCT06787521 | Recruiting

• 1 other identifier: OHSU IRB 28141
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Related

Keywords

Intrapartum; Labor Agency

Outcome Measures

Primary Outcomes (1)

• Labor Agentry Scale-10 (LAS-10)

  A validated questionnaire that measures patient-perceived control during labor

  1-7 days following delivery

Secondary Outcomes (5)

• Labor Interventions

  During labor

• Maternal hyper/hypotension

  During induction of labor

• Intrapartum blood loss

  Labor and delivery

• Cesarean section

  Delivery

• Time to delivery

  Admission for induction to delivery

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants will receive an evidence-based labor guide at the time of admission for scheduled induction of labor

Other: evidence-based labor guide

Control Group

NO INTERVENTION

Participants will receive the standard of care in-person counseling regarding options for labor interventions.

Interventions

evidence-based labor guide OTHER

Participants will be provided with written education about potential complications and interventions. Information will be provided at the time of admission for labor induction.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Study Officials

• Fei Cai, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Women's Health Research Unit Department of Ob/Gyn

CONTACT

503-494-3666; whru@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1:1 randomization will be done using REDCap.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)