Pregnancy Related
Conditions
Keywords
Intrapartum, Labor Agency
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.
Interventions
OTHERevidence-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.
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
1:1 randomization will be done using REDCap.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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 * Minors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Labor Agentry Scale-10 (LAS-10) | 1-7 days following delivery | A validated questionnaire that measures patient-perceived control during labor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFei Cai, MD
Oregon Health and Science University
Outcome results
None listed