Nipple Stimulation for Induction of Labour
(NSAIL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether using an electric breast pump for nipple stimulation can naturally initiate labor. The pump may trigger the release of oxytocin, a hormone that encourages contractions, potentially offering more control and shortening labor time compared to traditional methods like medications. Participants will either use the breast pump for labor induction or follow standard medical procedures. This trial suits those who are pregnant, at least 37 weeks along, and planning to deliver vaginally without major complications such as high blood pressure or a history of cesarean delivery. As an unphased trial, it provides a unique opportunity to explore a natural method for labor induction, potentially benefiting future pregnancies.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have chronic hypertension and are on medications, you would not be eligible for this study.
What prior data suggests that the electric breast pump for nipple stimulation is safe for inducing labor?
Research has shown that using a breast pump to stimulate the nipples is generally safe for initiating labor. Studies have found that this method does not increase infection rates compared to other methods. Most women, about 92%, report satisfaction with this process. The breast pump method works well, particularly for women with low-risk pregnancies, by using the body's natural hormone, oxytocin, to start contractions. This approach may be a good choice for those seeking more control over how their labor begins.12345
Why are researchers excited about this trial?
Unlike the standard induction of labor methods, which typically involve medications like misoprostol and synthetic oxytocin, this trial explores nipple stimulation as a natural way to kickstart labor. Researchers are excited because it could offer a non-invasive, drug-free alternative that might reduce the need for medications that come with side effects. The use of an electric breast pump for nipple stimulation is a unique approach, potentially making labor induction more comfortable and less medicalized for expecting mothers.
What evidence suggests that using an electric breast pump for nipple stimulation is effective for inducing labor?
This trial will compare nipple stimulation using a breast pump with standard induction methods for labor. Studies have shown that using a breast pump to stimulate the nipples can help start labor in some women. Research suggests this method can be effective, especially for those who have had a previous C-section. One study found that women who used nipple stimulation went into labor faster than with other methods. This technique triggers the release of oxytocin, a hormone that causes contractions. Many women have reported satisfaction with using this method to start labor. Overall, it appears to be a safe and effective way to help induce labor naturally.15678
Who Is on the Research Team?
Brian Brost, MD
Principal Investigator
Vice Chair of Education and Innovation in the Department of Obstetrics and Gynecology at the University of Kansas School of Medicine
Rachel DiTeresi, MD
Principal Investigator
Clerkship Director for Obstetrics and Gynecology Department at KUMC
Are You a Good Fit for This Trial?
This trial is for pregnant women aged 18-50, at full term (37-42 weeks), with intact amniotic membranes and a baby positioned head-down. Participants must speak English and be admitted for labor induction.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo induction of labor with or without nipple stimulation using the Symphony PLUS® breast pump
Follow-up
Participants are monitored for safety and effectiveness after delivery, including survey completion
What Are the Treatments Tested in This Trial?
Interventions
- Electric breast pump for nipple stimulation
Trial Overview
The study tests if using an electric breast pump to stimulate the nipples can help start labor naturally, compared to standard methods of inducing labor. The device encourages the body’s own oxytocin release to trigger contractions.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients randomized to the experimental group will undergo standard IOL protocol with the addition of nipple stimulation. At the time when the labor and delivery team deems a patient suitable for Pitocin initiation, patients will begin using a Symphony PLUS® breast pump for nipple stimulation. The breast pump will be turned on and placed on one breast (around the nipple) for 15 minutes, alternating breasts every 15 minutes. The default pump vacuum settings will be utilized. Contraction pattern and pump settings will be assessed every 30 minutes and adjusted if needed to maintain uterine contractions at a rate between 3 and 5 contractions per 10 minutes averaged over 30 minutes. Patients will perform nipple stimulation for no greater and no less than 2 hours. They will then resume normal care.
Patients randomized to the control group will follow standard induction of labor protocol, which may include, but is not limited to, misoprostol, Foley catheter, and synthetic oxytocin (Pitocin). In other words, their induction will be the same as if they were not enrolled in the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor
Citations
Breast stimulation for cervical ripening and induction of labour
Breast stimulation appears beneficial in relation to the number of women not in labour after 72 hours, and reduced postpartum haemorrhage rates.
Breast stimulation vs low dose oxytocin for labor ...
Tweetable Statement: Breast-stimulation by electrical-pump might be an effective labor-augmentation method for women with a previous cesarean delivery.
Stimulation Therapy to Induce Mothers
This study aims to examine whether inpatient nipple stimulation therapy is an efficacious labor induction method that increases the likelihood of spontaneous ...
4.
evidencebasedbirth.com
evidencebasedbirth.com/ebb-125-evidence-on-acupressure-acupuncture-and-breast-stimulation/EBB 125 - Evidence on Acupressure, Acupuncture and ...
92% of women in the breast stimulation group stated that they were satisfied with that induction method. Rebecca Dekker: In summary, the breast ...
5.
ctv.veeva.com
ctv.veeva.com/study/is-nipple-stimulation-effective-for-inducing-labor-and-acceptable-to-patients-nurses-and-providersIs Nipple Stimulation Effective for Inducing Labor and ...
In this study the investigators will be testing the use of the Symphony PLUS® breast pump for nipple stimulation. Typically, breast pumps ...
Intrapartum nipple stimulation therapy for labor induction
We aimed to assess whether conducting a large randomized controlled trial comparing intrapartum nipple stimulation therapy with oxytocin infusion is feasible ...
Breast Pump Usage is a Safe and Efficacious Method ...
Conclusion: Breast pump stimulation is an effective method to induce labor in pregnant women with risk factors for uterine rupture. Keywords: Labor Induction; ...
Breast Pump to Induce Labor: Does It Work, Safety, and More
Inducing labor through nipple simulation is generally considered safe if you have a low-risk, healthy pregnancy. But it's only safe to try at- ...
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