What side effects are associated with this type of intervention?

Intrapartum nipple stimulation, which naturally releases oxytocin, is a non-pharmacological method that can enhance labor contractions. Common pharmacological treatments for labor pain include oxytocin infusion and epidural analgesia. Oxytocin infusion can cause uterine hyperstimulation, potentially leading to fetal distress and an increased risk of cesarean delivery. Epidural analgesia is effective for pain relief but may result in maternal hypotension, prolonged labor, increased need for instrumental delivery, and maternal fever. Each method has its own set of risks and benefits that should be considered.

What prior FDA approvals exist?

The FDA has approved various pharmacological treatments for labor pain, including the use of synthetic oxytocin (Pitocin) to induce or augment labor by stimulating uterine contractions. Epidural analgesia, which involves the administration of anesthetics and opioids into the epidural space, is another common FDA-approved method for managing labor pain. While intrapartum nipple stimulation, which promotes the natural release of oxytocin, is being studied for its potential benefits in labor induction and pain management, it is not yet an FDA-approved method. Non-pharmacological approaches such as this are gaining interest for their potential to improve patient-centered outcomes without the use of synthetic drugs.

What other types of research exist?

Promising alternatives to intrapartum nipple stimulation for labor pain management in 2024 include electrical breast stimulation, transcutaneous electrical nerve stimulation (TENS), and transcranial magnetic stimulation (TMS). These methods are non-invasive and have shown potential in clinical trials for managing pain and stimulating uterine contractions.

← Back to Search

Hormone Therapy

Nipple Stimulation vs. Oxytocin Infusion for Inducing Labor (STIM Trial)

Q: What is the mechanism of action of this treatment?

Intrapartum nipple stimulation works by naturally increasing the release of oxytocin, a hormone that enhances uterine contractions and can facilitate labor progression, potentially leading to a higher rate of spontaneous vaginal delivery. This method is significant for labor pain patients as it may improve childbirth satisfaction and reduce the need for medical interventions. Pharmacological analgesia, such as the use of tramal, works by blocking pain signals in the nervous system, providing effective pain relief but with potential side effects. Acupuncture analgesia involves the insertion of fine needles into specific points on the body to release endorphins and other natural pain-relieving substances, offering a non-pharmacological option for pain management. Understanding these mechanisms helps patients and healthcare providers choose the most appropriate and effective pain management strategy during labor.

Phase 4

Recruiting

Led By Moeun Son, MD, MSCI

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gestational age 36 0/7 weeks and greater at enrollment

Spontaneous rupture of membranes or if membranes intact, modified Bishop score ≥5 and cervix dilated <6 cm within one hour of enrollment

Must not have

HIV infection

History of mastectomy or other contraindication to use of electronic breast pump

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after delivery to 12 weeks postpartum

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares nipple stimulation and a common medical intervention to start labor in first-time mothers. It aims to see if nipple stimulation can lead to better childbirth experiences and outcomes by boosting natural hormone levels.

Who is the study for?

This trial is for first-time mothers (nulliparous) who are at least 36 weeks pregnant, planning to start labor with oxytocin, and can consent. They must have a single baby in the correct position and not be in another study that affects labor or birth outcomes. Women with certain health conditions, previous nipple stimulation attempts, or planned cesarean deliveries cannot join.

What is being tested?

The study compares two methods of inducing labor: using an electric breast pump to naturally stimulate labor versus giving synthetic oxytocin through an IV without nipple stimulation. The goal is to see which method leads to more natural births and better outcomes for mother and baby.

What are the potential side effects?

Potential side effects from using the electric breast pump may include discomfort or soreness at the site of use. Synthetic oxytocin infusion might cause increased contractions leading to changes in fetal heart rate or other complications requiring medical attention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am at least 36 weeks pregnant.

Select...

My water has broken or I have a Bishop score ≥5 with cervix dilated <6 cm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am HIV positive.

Select...

I cannot use an electronic breast pump due to a mastectomy or other reasons.

Select...

I cannot understand English or Spanish.

Select...

I have severe difficulty thinking or staying awake.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately prior to up to immediately post delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately prior to up to immediately post delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately prior to up to immediately post delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Breastfeeding as the sole source of nutrition (BSSN)

Spontaneous vaginal delivery

Secondary study objectives

Cesarean delivery

Composite neonatal severe morbidity measure

Labor induction duration

+11 more

Other study objectives

Subject-reported ability to express and/or collect colostrum and/or breastmilk intrapartum

Subject-reported breastfeeding success

Subject-reported depression score

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intrapartum nipple stimulationExperimental Treatment1 Intervention

Participants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor.

Group II: Exogenous oxytocin intravenous infusionActive Control1 Intervention

Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intrapartum nipple stimulation works by naturally increasing the release of oxytocin, a hormone that enhances uterine contractions and can facilitate labor progression, potentially leading to a higher rate of spontaneous vaginal delivery. This method is significant for labor pain patients as it may improve childbirth satisfaction and reduce the need for medical interventions. Pharmacological analgesia, such as the use of tramal, works by blocking pain signals in the nervous system, providing effective pain relief but with potential side effects. Acupuncture analgesia involves the insertion of fine needles into specific points on the body to release endorphins and other natural pain-relieving substances, offering a non-pharmacological option for pain management. Understanding these mechanisms helps patients and healthcare providers choose the most appropriate and effective pain management strategy during labor.

[The effect of tramal and acupuncture analgesia on labor pain and the psychoemotional status of the parturient].