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OxytocinPhase 4STIMNCT05079841

The Stimulation To Induce Mothers Study

A Phase 4 study testing Electric breast pump and Exogenous oxytocin intravenous infusion without nipple stimulation. in people with Oxytocin and Labor Pain, run by Yale University at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Electric breast pump and Exogenous oxytocin intravenous infusion without nipple stimulation.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
933 participants
Where
3 sitesUnited States
Study dates
15 Nov 2021to Mar 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 15Show fewer
  • 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)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • Weill Cornell Medicine

    New York, New York, 10065

Other trials in United States

About this study

Official title: 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.

Read the 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.
Being tested
Electric breast pump, Exogenous oxytocin intravenous infusion without nipple stimulation.
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electric breast pumpDevice

    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 without nipple stimulation.Drug

    Also called Pitocin intravenous infusion

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

Study groups in NCT05079841
Study groupRoleWhat they receive
Intrapartum nipple stimulationExperimentalParticipants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor.
Receives: Device: Electric breast pump
Exogenous oxytocin intravenous infusionActive comparatorParticipants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor.
Receives: Drug: Exogenous oxytocin intravenous infusion without nipple stimulation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Spontaneous vaginal delivery

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

    Measured: At delivery

  2. 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)

    Measured: up to 72 hours following delivery

Secondary outcomes (14)

  1. Operative vaginal delivery

    Delivery with the assistance of forceps or vacuum, and indication

    Measured: At delivery

  2. Cesarean delivery

    Delivery by cesarean section

    Measured: At delivery

  3. Labor induction duration

    Time interval from randomization to delivery

    Measured: At delivery

  4. Number of Participants with Postpartum hemorrhage

    Cumulative blood loss of ≥1,000 mL within 24 hours after the birth process

    Measured: From delivery to 24 hours postpartum

  5. Number of Participants with Severe Postpartum hemorrhage

    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

    Measured: From delivery to 24 hours postpartum

  6. Number of participants with suspected infection

    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

    Measured: 3-7 days postpartum

  7. Lactational mastitis

    Subject-reported occurrence of lactational mastitis

    Measured: After delivery to 12 weeks postpartum

  8. Number of maternal deaths

    Incidence of maternal death prior to, during, or post delivery

    Measured: immediately prior to up to immediately post delivery

  9. Maternal Intensive Care Unit admission

    Any admission to the Intensive Care Unit after delivery and prior to delivery hospitalization discharge

    Measured: 3-7 days postpartum

  10. Neonatal Intensive Care Unit admission

    Any admission to the Neonatal Intensive Care Unit From birth to birth hospitalization discharge or 28 days after birth, whichever is earlier

    Measured: up to 28 days following birth

  11. Neonatal Apgar score ≤3 at 5 minutes of life

    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.

    Measured: At 5 minutes after birth

  12. Umbilical acidemia

    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

    Measured: At delivery

  13. Composite neonatal severe morbidity measure

    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

    Measured: up to 28 days following delivery

  14. Percent newborn weight loss

    Maximal percent newborn weight loss in kilograms(kg)

    Measured: At 72 hours of life or birth hospitalization discharge, whichever is earlier

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study start15 Nov 2021
  3. Primary completionNov 2028 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
933 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079841
Sponsor's protocol ID
2000031338
Other IDs
1R01HD111633-01, 231888-1
Acronym
STIM
Status last verified
Aug 2026
First submitted
20 Sep 2021
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 39207839

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Electric breast pump and Exogenous oxytocin intravenous infusion without nipple stimulation. in people with Oxytocin and Labor Pain, run by Yale University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spontaneous vaginal delivery (time frame: At delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05079841, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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