Nipple Stimulation vs. Oxytocin Infusion for Inducing Labor

(STIM Trial)

Recruiting at 2 trial locations

Overseen By Molly McAdow, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Yale University

Must be taking: Oxytocin

Disqualifiers: Non-vertex fetus, Multi-fetal gestation, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: From randomization to delivery

988 Participants Needed

Trial Summary

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. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Nipple Stimulation vs. Oxytocin Infusion for Inducing Labor?

Research shows that nipple stimulation can be a safe and effective alternative to oxytocin for inducing labor, as it can shorten the time to active labor and reduce the need for oxytocin. However, it may not always produce the same level of uterine activity as oxytocin, and some women may not respond to it. ^{1 2 3 4 5}

Is nipple stimulation safe for inducing labor compared to oxytocin?

Research suggests that nipple stimulation is generally safe for inducing labor and can be a safe alternative to oxytocin, although it may not always be as effective in producing strong uterine contractions. ^{1 2 3 5 6}

How does nipple stimulation compare to oxytocin infusion for inducing labor?

Nipple stimulation is a non-drug, non-invasive method that can induce labor by naturally increasing uterine activity, often leading to a quicker onset of labor compared to oxytocin infusion. However, oxytocin tends to produce stronger uterine contractions, and some women may not respond to nipple stimulation, requiring a switch to oxytocin. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Molly McAdow, MD, PhD

Principal Investigator

Yale University

Bethany Stetson, MD

Principal Investigator

Northwestern University

Moeun Son, MD, MSCI

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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.

Inclusion Criteria

I am at least 36 weeks pregnant.

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

Ability to give informed consent

Exclusion Criteria

The baby is not positioned head-down in the womb when the study starts.

Prior use of exogenous oxytocin or attempt at nipple stimulation during the current pregnancy

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intrapartum nipple stimulation or exogenous oxytocin infusion to induce labor

From randomization to delivery

In-hospital stay for labor induction and delivery

Postpartum Monitoring

Participants are monitored for breastfeeding success, maternal and neonatal outcomes, and satisfaction scores

3-7 days postpartum

In-hospital monitoring until discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment, including depression scores and breastfeeding success

4 to 12 weeks postpartum

Treatment Details

Interventions

• Exogenous Oxytocin Infusion
• Intrapartum Nipple Stimulation

Trial Overview 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.

Participant Groups

Group I: Intrapartum nipple stimulation Experimental Treatment 1 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 infusion Active Control 1 Intervention

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

Exogenous Oxytocin Infusion is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Pitocin for:

• Induction of labor
• Augmentation of labor
• Postpartum hemorrhage

Approved in European Union as Syntocinon for:

• Induction of labor
• Augmentation of labor
• Postpartum hemorrhage

Approved in Canada as Oxytocin for:

• Induction of labor
• Augmentation of labor
• Postpartum hemorrhage

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Nipple stimulation using an electric breast pump led to a quicker onset of regular uterine activity and a faster progression to active labor compared to oxytocin infusion.

Once active labor began, there were no significant differences in the length of labor or delivery methods between the two groups, indicating that both methods are effective for labor induction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of labor with an electric breast pump. Chayen, B., Tejani, N., Verma, U.[2006]

Nipple stimulation using a breast pump is a safe and effective alternative to oxytocin for augmenting labor, with no significant differences in labor duration or neonatal outcomes like Apgar scores.

While oxytocin resulted in higher uterine activity and faster cervical dilation for those who did not respond to nipple stimulation, it was associated with a higher cesarean section rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nipple stimulation for labor augmentation. Stein, JL., Bardeguez, AD., Verma, UL., et al.[2007]

In a study of 45 term pregnant women, both intermittent nipple stimulation and oxytocin infusion significantly increased uterine activity, but nipple stimulation achieved regular contractions more quickly but at a lower intensity.

The results indicate that nipple stimulation may not be a suitable substitute for oxytocin infusion in contraction stress tests, as 20% of women did not achieve adequate contractions and some experienced uterine hyperstimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of uterine activity induced by nipple stimulation and oxytocin. Mashini, IS., Devoe, LD., McKenzie, JS., et al.[2009]

Nipple stimulation during labor significantly reduced the duration of the latent phase of labor in 222 pregnant women, with a median duration of 3.2 hours compared to 4.8 hours in the control group (p = 0.008).

Women who received nipple stimulation required significantly less oxytocin treatment (p = 0.001), suggesting that this method can be an effective non-pharmacological approach to manage labor progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effect of nipple stimulation during labour on labour progression in term pregnant women. Mousavi, S., Rouhollahi, B., Zakariya, NA., et al.[2022]

Nipple stimulation is a safe method for managing the third stage of labor, providing an alternative to the use of oxytocin.

This approach may offer a non-pharmacological option for facilitating uterine contractions during labor, potentially reducing reliance on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of the third stage of labor with nipple stimulation. Kim, YM., Tejani, N., Chayen, B., et al.[2006]

The nipple stimulation contraction stress test is emerging as a practical and effective alternative to the more expensive and time-consuming oxytocin challenge test for assessing fetal well-being.

Current literature supports the nipple stimulation contraction stress test's predictive value for perinatal outcomes, and clear guidelines are provided for its safe and effective use in antepartum testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nipple stimulation contraction stress test. Marshall, C.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Induction of labor with an electric breast pump. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Nipple stimulation for labor augmentation. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of uterine activity induced by nipple stimulation and oxytocin. [2009]

4. England pubmed.ncbi.nlm.nih.gov

Evaluating the effect of nipple stimulation during labour on labour progression in term pregnant women. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Management of the third stage of labor with nipple stimulation. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

The nipple stimulation contraction stress test. [2019]