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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to induce labor: nipple stimulation and oxytocin infusion. The researchers aim to determine if nipple stimulation can lead to more natural births, improved childbirth experiences, and healthier outcomes for both mother and baby. Women may qualify if they are having their first baby, are at least 36 weeks pregnant with one baby, and have been advised to start labor with oxytocin. Participants will either use a breast pump or hand stimulation to induce labor or receive oxytocin (a hormone) through an IV. As a Phase 4 trial, this research seeks to understand how these FDA-approved treatments can benefit more patients.

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 is the safety track record for these treatments?

Research has shown that stimulating the nipples during labor is a promising method to initiate labor. One study found that it did not lead to more infections than other methods, with infection rates remaining below 9%. This indicates that many women tolerate it well.

The FDA has approved oxytocin, a hormone, to help start labor and control bleeding after childbirth. It has been widely used and is effective, especially when combined with breaking the water. Studies have shown it does not increase risks for mothers or babies during labor.

Both treatments in this trial have strong safety records. Prospective participants should know that evidence supports their safety in humans. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about comparing nipple stimulation to oxytocin infusion for inducing labor because it could offer a more natural and less invasive option. Unlike the standard oxytocin infusion, which requires an IV and close monitoring, nipple stimulation can be done using an electric breast pump or by hand, potentially making it more accessible and comfortable for some expectant mothers. Additionally, this method could reduce the need for medication and its associated side effects, providing a gentler alternative for inducing labor.

What evidence suggests that this trial's treatments could be effective for inducing labor?

This trial will compare two methods for inducing labor: intrapartum nipple stimulation and exogenous oxytocin infusion. Research has shown that stimulating the nipples during labor can help start contractions. One study found it took about 16.4 hours from the start of nipple stimulation to delivery. This method has been used successfully in the past to encourage labor. Participants in this trial may be randomized to receive nipple stimulation as a natural option. Conversely, using oxytocin, a common medication, effectively induces labor, with strong evidence supporting its use in medical settings. Participants in this trial may also be randomized to receive oxytocin infusion. Both methods aim to start labor, but nipple stimulation might offer a more natural option. ^{6 7 8 9 10}

Who Is on the Research Team?

Bethany Stetson, MD

Principal Investigator

Northwestern University

Molly McAdow, MD, PhD

Principal Investigator

Yale University

Moeun Son, MD, MSCI

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933322000155

Intrapartum nipple stimulation therapy for labor induction RESULTS. A total of 620 women underwent labor induction from March 13, 2021 to June 23, 2021. Of 557 potentially eligible women, 53 were approached ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35042047/

Intrapartum nipple stimulation therapy for labor induction Results: A total of 620 women underwent labor induction from March 13, 2021 to June 23, 2021. Of 557 potentially eligible women, 53 were ...

3. ajogmfm.org ajogmfm.org/article/S2589-9333(22)00015-5/abstract

Intrapartum nipple stimulation therapy for labor induction The median times from intervention start to delivery were 16.4 (interquartile range, 0.6–28.2) hours for women assigned to nipple stimulation ...

4. researchprotocols.org researchprotocols.org/2024/1/e63463/

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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04756089

NCT04756089 | Stimulation Therapy for Inducing Mothers Breast stimulation was historically used successfully for inducing contractions for the purposes of contraction stress testing. A Cochrane review was performed ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK507848/

Oxytocin - StatPearls - NCBI Bookshelf - NIH Oxytocin is FDA-approved for use in the antepartum and postpartum periods to facilitate labor and control postpartum hemorrhage.

7. ajog.org ajog.org/article/S0002-9378(23)00081-9/fulltext

Methods for the induction of labor: efficacy and safety Oxytocin is more effective than expectant management in inducing labor, and the efficacy of oxytocin is enhanced when combined with amniotomy.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8363560/

Review of Evidence-Based Methods for Successful Labor ... This article provides a review of the current research evidence on labor induction methods, including cervical ripening techniques and contraction stimulation ...

9. ajog.org ajog.org/article/S0002-9378(23)00439-8/fulltext

Oxytocin: physiology, pharmacology, and clinical ... They found that active labor management with the early use of oxytocin reduced the length of labor by approximately 2 hours (−2.20 hours; 95% CI ...

10. sarawickham.com sarawickham.com/research-updates/oxytocin-and-birth-the-latest-evidence/

Oxytocin and birth: the latest evidence A systematic review has confirmed that, when exogenous (or 'made outside the body') oxytocin is given in labour, neither mums nor babies will experience the ...