The Stimulation To Induce Mothers Study (STIM)

March 19, 2026 updated by: Yale University

The Stimulation To Induce Mothers (STIM) Study: A Parallel Group Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
988

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Hospital
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Active, not recruiting
        • Northwestern Memorial Hospital
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intrapartum nipple stimulation
Participants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor.
Device: 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
Other Names:
  • Medela Symphony pump
Active Comparator: Exogenous oxytocin intravenous infusion
Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor.
Drug: 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
Other Names:
  • Pitocin intravenous infusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Spontaneous vaginal delivery
Time Frame: At 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)
Time Frame: up to 72 hours following delivery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Operative vaginal delivery
Time Frame: At delivery
Delivery with the assistance of forceps or vacuum, and indication
At delivery
Cesarean delivery
Time Frame: At delivery
Delivery by cesarean section
At delivery
Labor induction duration
Time Frame: At delivery
Time interval from randomization to delivery
At delivery
Neonatal Apgar score ≤3 at 5 minutes of life
Time Frame: At 5 minutes after birth
The Neonatal Apgar score is scored from 0 to 10. A 5-minute Apgar score of 0-3 correlates with neonatal mortality in large population studies.
At 5 minutes after birth
Umbilical acidemia
Time Frame: At delivery
Umbilical cord arterial pH <7.0 or base excess >12 mmol/L; or umbilical cord venous pH <7.0 or base excess >12 mmol/L if arterial blood sample not available
At delivery
Composite neonatal severe morbidity measure
Time Frame: up to 28 days following delivery
Intrapartum fetal death or neonatal death; cardiorespiratory support within first 72 hours of life; neonatal encephalopathy; seizures; hypothermic treatment (cooling); sepsis; pneumonia; major birth injury; meconium aspiration syndrome; intracranial hemorrhage or subgaleal hemorrhage; or hypotension requiring pressor support
up to 28 days following delivery
Lactational mastitis
Time Frame: After delivery to 12 weeks postpartum
Subject-reported occurrence of lactational mastitis
After delivery to 12 weeks postpartum
Number of Participants with Postpartum hemorrhage
Time Frame: From delivery to 24 hours postpartum
Cumulative blood loss of ≥1,000 mL within 24 hours after the birth process
From delivery to 24 hours postpartum
Number of Participants with Severe Postpartum hemorrhage
Time Frame: From delivery to 24 hours postpartum
Transfusion; non-elective hysterectomy; use of ≥2 uterotonic medications other than oxytocin; other interventions such as uterine compression sutures, uterine artery ligation or embolization, hypogastric artery ligation, balloon tamponade
From delivery to 24 hours postpartum
Number of participants with suspected infection
Time Frame: 3-7 days postpartum
Suspected intraamniotic infection, intrapartum chorioamnionitis, or postpartum endometritis (defined as maternal fever ≥38° Fahrenheit with planned or initiated administration of therapeutic antibiotics) after randomization and prior to delivery hospitalization discharge
3-7 days postpartum
Number of maternal deaths
Time Frame: immediately prior to up to immediately post delivery
Incidence of maternal death prior to, during, or post delivery
immediately prior to up to immediately post delivery
Maternal Intensive Care Unit admission
Time Frame: 3-7 days postpartum
Any admission to the Intensive Care Unit after delivery and prior to delivery hospitalization discharge
3-7 days postpartum
Neonatal Intensive Care Unit admission
Time Frame: up to 28 days following birth
Any admission to the Neonatal Intensive Care Unit From birth to birth hospitalization discharge or 28 days after birth, whichever is earlier
up to 28 days following birth
Percent newborn weight loss
Time Frame: At 72 hours of life or birth hospitalization discharge, whichever is earlier
Maximal percent newborn weight loss in kilograms(kg)
At 72 hours of life or birth hospitalization discharge, whichever is earlier

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subject-reported pain during childbirth
Time Frame: At intervention start and than again 2 hours after intervention start
Visual analog scale, scored with Likert scale from 0 (no pain) to 10 (worst pain)
At intervention start and than again 2 hours after intervention start
Subject-reported feelings of control during labor and childbirth
Time Frame: 6-96 hours after delivery
Labor Agentry Scale is a 29-item survey designed to assess expectations and experiences of personal control during childbirth (scores range from 29 to 203, with higher scores indicating greater perceived control during childbirth)
6-96 hours after delivery
Subject-reported depression score
Time Frame: 4 to 12 weeks after delivery
Edinburgh Postnatal Depression Scale is a 10-item self report scored from 0 to 30; score >10 warrants additional clinical assessment for depression
4 to 12 weeks after delivery
Subject-reported satisfaction during labor and childbirth
Time Frame: 6-96 hours after delivery
Birth Satisfaction Scale-Revised (BSS-R) is a 10-item self-report valid and reliable measure (scores range from 0 to 40, 0 being the least satisfaction and 40 being the most satisfaction)
6-96 hours after delivery
Subject-reported breastfeeding success
Time Frame: 4 to 12 weeks after delivery
Maternal Breastfeeding Evaluation Scale (MBES) is a 30-item using a 5-point Likert scale with higher scores reflecting more positive breastfeeding experiences.
4 to 12 weeks after delivery
Subject-reported ability to express and/or collect colostrum and/or breastmilk intrapartum
Time Frame: From randomization to hospital discharge, approximately 3-7 days
Participants ability to express and/or collect colostrum and/or breastmilk intrapartum
From randomization to hospital discharge, approximately 3-7 days
Subject-reported perception of milk supply
Time Frame: 2 weeks postpartum
Subject-reported perception of milk supply using the validated Perception of Insufficient Milk Supply (PIMS). PIM is defined as a state in which a mother has or perceives that she has an inadequate supply of breast milk to meet her infant's needs. A perception of insufficient milk supply is associated with early discontinuation of breastfeeding.
2 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bethany Stetson, MD, Northwestern University
  • Principal Investigator: Moeun Son, MD, MSCI, Weill Medical College of Cornell University
  • Principal Investigator: Molly McAdow, MD, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000031338
  • 1R01HD111633-01 (U.S. NIH Grant/Contract)
  • 231888-1 (Other Grant/Funding Number: Cornell University, Joan and Sanford I. Weill Medical College)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will become available after publication and will be available for 5 years.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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