PEAICE: Patient Empowerment and Agency Through Intrapartum Counseling and Education: a Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Labor Agentry Scale-10 (LAS-10)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental Group
Participants will receive an evidence-based labor guide at the time of admission for scheduled induction of labor
Intervention: evidence-based labor guide (Other)
Control Group
Participants will receive the standard of care in-person counseling regarding options for labor interventions.
Outcomes
Primary Outcomes
Labor Agentry Scale-10 (LAS-10)
Time Frame: 1-7 days following delivery
A validated questionnaire that measures patient-perceived control during labor
Secondary Outcomes
- Time to delivery(Admission for induction to delivery)
- Labor Interventions(During labor)
- Maternal hyper/hypotension(During induction of labor)
- Intrapartum blood loss(Labor and delivery)
- Cesarean section(Delivery)
Investigators
Fei Cai
Principal Investigator
Oregon Health and Science University