Stimulation Therapy for Inducing Mothers
Completed · Not applicable
Conditions studied: Induced; Birth, Labor Long, Labor Pain, Breast Pumping, Lactation Induced
In brief
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) Breast stimulation by hand or with an electronic breast pump (intervention) compared to (2) Exogenous oxytocin intravenous infusion (current standard of care, control). The pilot study will be randomized since one of the goals is to evaluate whether the idea of randomization would be acceptable to patients.
Key facts
- Study ID
- NCT04756089
- Run by
- Yale University
- People needed
- 24
- Starts
- 2021-03-13
- Expected to finish
- 2021-06-23
- Last updated by the study team
- 2021-09-05
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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