CompletedNot Applicable

Stimulation Therapy for Inducing Mothers

United States24 participantsStarted 2021-03-13

Plain-language 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) 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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)

What they're measuring

Recruitment (enrollment) rate

Timeframe: 3 months

Adherence rate

Timeframe: 3 months

Cross-over frequencies

Timeframe: 3 months

Trial details

NCT IDNCT04756089

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-23

View on ClinicalTrials.gov More Induced; Birth trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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)