The Stimulation To Induce Mothers Study

NCT ID: NCT05079841

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 988 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2029-03-31

Brief Summary

The investigators propose a parallel group randomized clinical trial of intrapartum nipple stimulation versus exogenous oxytocin infusion for nulliparous women undergoing induction of labor near term. The central hypothesis is that intrapartum nipple stimulation to induce labor increases spontaneous vaginal delivery, improves patient-centered outcomes such as childbirth satisfaction, labor agentry, and pain scores, and reduces adverse neonatal and maternal outcomes in nulliparous women. The investigators will pursue the following specific aims: 1) Assess the effectiveness of intrapartum nipple stimulation on the rate of spontaneous vaginal delivery in nulliparous women, 2) Breastfeeding as the sole source of nutrition at time of maternal hospital discharge (Primary Aims); 3) Maximal percent newborn weight loss during the birth hospitalization within 72 hours of life, 4) Determine the effect of intrapartum nipple stimulation on the rate of adverse maternal and neonatal outcomes, 5) Determine the impact of intrapartum nipple stimulation on patient-centered outcomes and 6) In a sub-cohort of women who are enrolled in the trial, investigators will measure the change in oxytocin concentration from baseline to time at which patient achieves a regular contraction pattern.

Detailed Description

Primary Objectives

1. To determine whether intrapartum nipple stimulation therapy with or without synthetic oxytocin changes the likelihood of achieving a spontaneous vaginal delivery compared to receipt of synthetic oxytocin infusion without nipple stimulation to induce labor.

2. Breastfeeding as the sole source of nutrition at time of maternal hospital discharge

Secondary Objectives (if applicable)

The secondary objectives are as follows:

1. Determine whether intrapartum nipple stimulation therapy with or without synthetic oxytocin changes the likelihood of achieving a spontaneous vaginal delivery compared to receipt of synthetic oxytocin infusion without nipple stimulation to induce labor.

2. Determine if women who perform intrapartum nipple stimulation to induce labor have differences in other obstetric and maternal outcomes

3. Determine if women who perform intrapartum nipple stimulation report differences in pain scores during labor, labor agentry and satisfaction scores, postpartum depression scores, and breastfeeding success compared to women who receive only intrapartum exogenous oxytocin infusion.

4. Determine if women who perform intrapartum nipple stimulation to induce labor have similar fetal and neonatal outcomes compared to women who receive only intrapartum exogenous oxytocin infusion.

5. Maximal percent newborn weight loss during the birth hospitalization within 72 hours of life

6. At Yale, to measure the change in oxytocin concentration from baseline over the course of labor induction in patients undergoing induction of labor via intrapartum nipple stimulation versus continuous exogenous oxytocin infusion.

7. At Yale, to measure circulating plasma and urine concentrations of proteins, microRNA, and small molecules using unbiased "omics" approaches, comparing patients undergoing induction of labor via intrapartum nipple stimulation versus continuous exogenous oxytocin infusion, un-ripened/unlabored control patients, and patients in spontaneous labor.

Conditions

Oxytocin; Labor Pain; Induction of Labor Affected Fetus / Newborn; Physiologic Effects of Drugs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intrapartum nipple stimulation

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

Group Type: EXPERIMENTAL

Electric breast pump

Intervention Type: DEVICE

Participants randomized to the intrapartum nipple stimulation will use electric breast pump or nipple stimulate by hand (if preferred) (intervention) to induce labor for at least 2 hours

Exogenous oxytocin intravenous infusion

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

Group Type: ACTIVE_COMPARATOR

Exogenous oxytocin intravenous infusion without nipple stimulation.

Intervention Type: DRUG

Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor as current standard of care

Interventions

Electric breast pump

Participants randomized to the intrapartum nipple stimulation will use electric breast pump or nipple stimulate by hand (if preferred) (intervention) to induce labor for at least 2 hours

Intervention Type: DEVICE

Exogenous oxytocin intravenous infusion without nipple stimulation.

Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor as current standard of care

Intervention Type: DRUG

Other Intervention Names

Pitocin intravenous infusion

Eligibility Criteria

Inclusion Criteria

• Nulliparous
• Gestational age 36 0/7 weeks and greater at enrollment
• Singleton gestation
• Planned to undergo initiation of exogenous oxytocin infusion by their maternity care provider
• Spontaneous rupture of membranes or if membranes intact, modified Bishop score ≥5 and cervix dilated <6 cm within one hour of enrollment
• Ability to give informed consent

Exclusion Criteria

• Unable to understand English or Spanish
• Prior use of exogenous oxytocin or attempt at nipple stimulation during the current pregnancy
• Presence of tachysystole (defined as more than 5 contractions in 10 minutes averaged over 30 minutes), recurrent variable or late fetal decelerations, and bradycardia in the prior 30 minutes before enrollment
• Non-vertex presenting fetus at time of enrollment
• Planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes infection, previous transmural myomectomy)
• Multi-fetal gestation (e.g., twins, triplets, and higher-order multiples)
• Intrauterine fetal death
• Major fetal anomaly suspected prenatally (defined as a fetal anomaly with anticipated neonatal intensive care unit admission)
• Suspected alloimmunization (given the increased likelihood for anticipated neonatal intensive care unit admission)
• Known severe fetal growth restriction (estimated fetal weight <3rd percentile) or abnormal umbilical artery Doppler studies (given the increased likelihood for anticipated neonatal intensive care unit admission)
• HIV infection (nipple stimulation is not encouraged given the recommendation for these mothers not to breastfeed)
• Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality
• History of mastectomy or other contraindication to use of electronic breast pump
• Known allergic reactions to components of the electronic breast pump or to synthetic oxytocin intravenous solution
• Significantly impaired consciousness or executive function (e.g., intubated or sedated)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Molly McAdow, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Bethany Stetson, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Moeun Son, MD, MSCI

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status: RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status: ACTIVE_NOT_RECRUITING

Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Moeun Son, MD, MSCI

Role: CONTACT

mos7003@med.cornell.edu

(212) 746-2106

Molly McAdow, MD, PhD

Role: CONTACT

molly.mcadow@yale.edu

References

Tortal D, Shabanova V, Taylor S, Xu X, McAdow M, Stetson B, McCollum S, Sanchez E, Adjakple A, Leventhal J, Son M. Stimulation Therapy to Induce Mothers: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 29;13:e63463. doi: 10.2196/63463.

Reference Type: DERIVED

PMID: 39207839 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01HD111633-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

231888-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2000031338

Identifier Type: -

Identifier Source: org_study_id