Status:
COMPLETED
Stimulation Therapy for Inducing Mothers
Lead Sponsor:
Yale University
Conditions:
Induced; Birth
Labor Long
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This is a pilot feasibility and acceptability study of a randomized clinical trial of pregnant women at 36 weeks of gestation and greater randomized to one of two arms at Yale New Haven Hospital: (1) ...
Detailed Description
Almost four million women give birth each year in the United States with more than 27% of them undergoing induction of labor. Generally, labor induction is indicated when the benefits of expeditious d...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age 18 years and older
- Gestational age 36 weeks and greater at randomization
- Vertex-presenting singleton gestation, or presenting gestation (a.k.a. Fetus A) is vertex-presenting in a multiple gestation
- Undergoing induction of labor
- Planned to undergo initiation of exogenous oxytocin infusion by their maternity care provider
- Absence of tachysystole (defined as more than 5 contractions in 10 minutes averaged over 30 minutes), recurrent variable or late fetal decelerations, and bradycardia in the prior 30 minutes before randomization
Exclusion
- Unable to understand English
- Planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes infection, uncontrolled HIV infection, previous transmural myomectomy)
- Fetal demise
- Major fetal anomaly suspected prenatally (defined as a fetal anomaly with anticipated neonatal intensive care unit admission)
- Suspected fetal growth restriction (EFW \<10th percentile)
- Suspected alloimmunization
- Unexplained active vaginal bleeding
- History of mastectomy, breast lumpectomy, or contraindication to use of electronic breast pump
- Known allergic reactions to components of the electronic breast pump or to synthetic oxytocin intravenous solution
- Impairment of upper extremity motor function (e.g., quadriplegia)
- Significantly impaired consciousness or executive function (e.g., intubated or sedated)
Key Trial Info
Start Date :
March 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04756089
Start Date
March 13 2021
End Date
June 23 2021
Last Update
September 5 2021
Active Locations (1)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510