The Stimulation To Induce Mothers Study

NCT05079841 | Recruiting Phase 4 DMC FDA Drug FDA Device

• 3 other identifiers: 20000313381R01HD111633-01231888-1
• Study Type: interventional
• Target: 988
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Spontaneous vaginal delivery

  Spontaneous vaginal delivery will be defined as delivery that occurs without the use of forceps, vacuum, or cesarean

  At delivery

• Breastfeeding as the sole source of nutrition (BSSN)

  Number of participants using breastfeeding as the sole source of nutrition (BSSN) at time of maternal discharge or 72 hours of life (whichever is sooner)

  up to 72 hours following delivery

Secondary Outcomes (14)

• Operative vaginal delivery

  At delivery

• Cesarean delivery

  At delivery

• Labor induction duration

  At delivery

• Number of Participants with Postpartum hemorrhage

  From delivery to 24 hours postpartum

• Number of Participants with Severe Postpartum hemorrhage

  From delivery to 24 hours postpartum

Other Outcomes (7)

• Subject-reported pain during childbirth

  At intervention start and than again 2 hours after intervention start

• Subject-reported satisfaction during labor and childbirth

  6-96 hours after delivery

• Subject-reported feelings of control during labor and childbirth

  6-96 hours after delivery

Study Arms (2)

Intrapartum nipple stimulation

EXPERIMENTAL

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

Device: Electric breast pump

Exogenous oxytocin intravenous infusion

ACTIVE COMPARATOR

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

Drug: Exogenous oxytocin intravenous infusion without nipple stimulation.

Interventions

Electric breast pump 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

Intrapartum nipple stimulation

Exogenous oxytocin intravenous infusion without nipple stimulation. DRUG

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

Also known as: Pitocin intravenous infusion

Exogenous oxytocin intravenous infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

ACTIVE NOT RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39207839 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Molly McAdow, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• Bethany Stetson, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Moeun Son, MD, MSCI

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moeun Son, MD, MSCI

CONTACT

(212) 746-2106; mos7003@med.cornell.edu

Molly McAdow, MD, PhD

CONTACT

molly.mcadow@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 15, 2021
• Study Start: November 15, 2021
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will become available after publication and will be available for 5 years.
• Access Criteria: De-identified data will be shared with academic researchers for secondary analyses or meta-analyses only after approval from the principal investigator and using an IRB-approved mechanism.

Locations

US (3)