Patient Empowerment and Agency Through Intrapartum Counseling and Education

Not Applicable

Not yet recruiting

• Conditions: Pregnancy Related

• Registration Number: NCT06787521
• Lead Sponsor: Oregon Health and Science University

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

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 Timeline

• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-22
• Status Verified: 2025-03
• Study Start: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 204

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Labor Agentry Scale-10 (LAS-10)	1-7 days following delivery	A validated questionnaire that measures patient-perceived control during labor

Secondary Outcome Measures

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