Is Nipple Stimulation Effective for Inducing Labor and Acceptable to Patients, Nurses, and Provid… (NCT07588529) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Is Nipple Stimulation Effective for Inducing Labor and Acceptable to Patients, Nurses, and Providers?
United States48 participantsStarted 2026-07
Plain-language summary
In this study the investigators will be testing the use of the Symphony PLUS® breast pump for nipple stimulation. Typically, breast pumps are used to start breast milk production and collect breast milk in patients after delivering their baby. The device uses cup-shaped pieces called flanges that are placed over the patient's nipples and then a gentle vacuum or suction is applied. The mechanical effect of the suction on the nipple is thought to cause the release of a substance called oxytocin in one's body, which encourages labor and contractions to begin. Some reasons why nipple stimulation might be better than other induction of labor methods are that it allows the patient to have more control over their induction process, it uses the patient's own oxytocin instead of synthetic (or factory-produced) oxytocin, and it may shorten the time that it takes to deliver the baby.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
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:
All patients presenting to KUMC labor \& delivery for IOL will be considered for this study.
Maternal
* ≥18 years old and ≤ 50 years old
* ≥37wga and ≤ 42wga
* Intact amniotic membranes
* English speaking Fetal
* Cephalic presentation
Exclusion Criteria:
Maternal
* Inability to give informed consent
* History of cesarean delivery or uterine myomectomy
* History of uterine rupture
* Intrahepatic cholestasis of pregnancy
* Maternal life-threatening conditions
* Active HSV
* Gestational hypertension, Preeclampsia (severe or w/o severe features), HELLP, chronic hypertension on medications
Placental
* Placenta previa, vasa previa
* Suspicion for abnormally adherent placenta
* Chorioamnionitis
* Placental abruption
Fetal
* Multifetal gestation
* category 2 or 3 fetal heart tracing upon presentation (does not include isolated variable deceleration)
* EFW \> 5000 grams in mother with diabetes
* EFW \> 4500 grams in mother without diabetes
* Fetal demise
* Fetal growth restriction \<10th centile
* Any other contraindication for vaginal birth or anticipation of need for NICU for care of baby
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Duration of Labor
Timeframe: From beginning of induction of labor to delivery of the baby (for each patient).