Induction of Labor Affected Fetus / Newborn
Conditions
Keywords
Foley balloon catheter, Outpatient cervical ripening
Brief summary
A multicenter pragmatic randomized trial of nulliparous women undergoing a term (≥37 weeks) induction of labor wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing outpatient cervical ripening with a Foley catheter to routine inpatient cervical ripening (Foley +/- other method). With this trial, the investigators aim to test our central hypothesis that outpatient Foley will decrease the primary Cesarean Delivery (CD) rate and risk of maternal/neonatal morbidity compared with inpatient cervical ripening.
Interventions
Outpatient Foley catheter placement for induction of labor
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor will be blinded to the group allocation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Eligible for induction of labor * Live singleton gestation ≥37 weeks and \<42 weeks * Nulliparous, ≥18 years of age with no previous deliveries \>20 weeks * Cephalic presentation * Intact membranes * Bishop score ≤8 and cervical dilation \<3 cm * English or Spanish speaking (Able to read/understand consent and instructions) * Have reliable transportation to get back to the hospital and have a self-reported safe residence to go home to with the Foley catheter
Exclusion criteria
* Known oligohydramnios (DVP \<2cm) * Known moderate-severe polyhydramnios (AFI ≥30 at time of delivery) * Concern regarding fetal status during antenatal testing: At provider discretion, but includes fetal decelerations, biophysical profile ≤6/10 * Vaginal bleeding or concern for/known abruption prior to Foley placement * Chorioamnionitis * Any fetal growth restriction * Preeclampsia with severe features * Severe chronic hypertension * Type 1 diabetes or poorly controlled pre-gestational diabetes * Sickle cell disease * Major fetal anomaly * Women on therapeutic anticoagulation * Decreased fetal movement * HIV Positive (rationale: HIV positive patients require an IV medication at the start of labor induction which cannot be given as an outpatient. There is universal testing of HIV in the 3rd trimester to verify this
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Cesarean Delivery | At delivery | Incidence of cesarean delivery in women randomized to outpatient cervical ripening with the Foley catheter compared to women undergoing routine inpatient cervical ripening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal morbidity incidence | Within 6 weeks of delivery | Defined as a composite endpoint consisting of at least one occurrence of the following outcomes: postpartum hemorrhage, blood transfusion, endometritis, wound/laceration breakdown or infection, venous thromboembolis and hospital readmission with 6 weeks |
| Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R) | From time of delivery to discharge from hospital, up to 6 weeks from delivery | Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction |
| Neonatal morbidity incidence | Within 6 weeks of delivery | Defined as a composite endpoint consisting of at least one incidence of the following outcomes: acidemia, respiratory failure/insufficiency, hypoxic-ischemic encephalopathy, treatment for hypoglycemia or suspected sepsis |
| Maternal patient perception of control | From time of delivery to discharge from hospital, up to 6 weeks from delivery | Measured by the Labour Agentry Scale (LAS), as 29-item questionnaire with higher values reflecting a higher measure of perceived personal control |
| Maternal overall length of stay | From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery | Measured by hours from admission to postpartum discharge |
| Maternal postpartum length of stay | From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery | Measured by hours from delivery to postpartum discharge |
| Neonatal length of stay | From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery | Length of stay from birth to discharge, measured in hours |
| NICU admission | From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery | Admission to neonatal intensive care unit |
| NICU stay greater than 48 hours | From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery | Admission to the NICU for more than 48 hours |
| Perceived stress scale-10 questions | From time of delivery to discharge from hospital, up to 6 weeks from delivery | A validated 10 question scale evaluating perceived stress |
Countries
United States
Contacts
CONTACTLisa Levine, MD, MSCE
CONTACTMeaghan McCabe, MPH
PRINCIPAL_INVESTIGATORLisa Levine, MD, MSCE
University of Pennsylvaina
PRINCIPAL_INVESTIGATORAlison Cahill, MD, MSCI
University of Texas at Austin
Outcome results
None listed