Patient Empowerment and Agency Through Intrapartum Counseling and Education

NCT ID: NCT06787521

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomization will be done using REDCap.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental Group

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

Group Type EXPERIMENTAL

evidence-based labor guide

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Fei Cai

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fei Cai, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Women's Health Research Unit Department of Ob/Gyn

Role: CONTACT

503-494-3666

Facility Contacts

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Fei Cai, MD

Role: primary

(503) 418-4200

Other Identifiers

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OHSU IRB 28141

Identifier Type: -

Identifier Source: org_study_id

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