Trial · Interventional

Active, not recruitingPhase 4Registry data

The Stimulation To Induce Mothers Study

Short name STIM

NCTNCT05079841Other id2000031338Other id1R01HD111633-01Other id231888-1

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Active, not recruiting
Phase: Phase 4
Enrollment: 933 participants (actual)
Sponsor: Yale University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 15 Nov 2021
Primary completion: Nov 2028 (estimated)
Completion: Mar 2029 (estimated)
First posted: 15 Oct 2021
Last update posted: 17 Aug 2026
Conditions: Oxytocin · Labor Pain · Induction of Labor Affected Fetus / Newborn · Physiologic Effects of Drugs

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20222024202620282030

Ph 4
STIM
NCT05079841
15 Nov 2021 to est. Mar 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Electric breast pumpDevice
Exogenous oxytocin intravenous infusion without nipple stimulation.Drug

Arms2

Experimental
Intrapartum nipple stimulation
Participants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor.
Active comparator
Exogenous oxytocin intravenous infusion
Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor.

Primary outcomes2

Outcomes the sponsor listed as primary.

Spontaneous vaginal delivery
Time frame · At delivery
Registry description
Spontaneous vaginal delivery will be defined as delivery that occurs without the use of forceps, vacuum, or cesarean
Breastfeeding as the sole source of nutrition (BSSN)
Time frame · up to 72 hours following delivery
Registry description
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)

Secondary outcomes(14)

Operative vaginal delivery
Time frame · At delivery
Registry description
Delivery with the assistance of forceps or vacuum, and indication
Cesarean delivery
Time frame · At delivery
Registry description
Delivery by cesarean section
Labor induction duration
Time frame · At delivery
Registry description
Time interval from randomization to delivery
Number of Participants with Postpartum hemorrhage
Time frame · From delivery to 24 hours postpartum
Registry description
Cumulative blood loss of ≥1,000 mL within 24 hours after the birth process
Number of Participants with Severe Postpartum hemorrhage
Time frame · From delivery to 24 hours postpartum
Registry description
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
Number of participants with suspected infection
Time frame · 3-7 days postpartum
Registry description
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
Lactational mastitis
Time frame · After delivery to 12 weeks postpartum
Registry description
Subject-reported occurrence of lactational mastitis
Number of maternal deaths
Time frame · immediately prior to up to immediately post delivery
Registry description
Incidence of maternal death prior to, during, or post delivery
Maternal Intensive Care Unit admission
Time frame · 3-7 days postpartum
Registry description
Any admission to the Intensive Care Unit after delivery and prior to delivery hospitalization discharge
Neonatal Intensive Care Unit admission
Time frame · up to 28 days following birth
Registry description
Any admission to the Neonatal Intensive Care Unit From birth to birth hospitalization discharge or 28 days after birth, whichever is earlier
Neonatal Apgar score ≤3 at 5 minutes of life
Time frame · At 5 minutes after birth
Registry description
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.
Umbilical acidemia
Time frame · At delivery
Registry description
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
Composite neonatal severe morbidity measure
Time frame · up to 28 days following delivery
Registry description
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
Percent newborn weight loss
Time frame · At 72 hours of life or birth hospitalization discharge, whichever is earlier
Registry description
Maximal percent newborn weight loss in kilograms(kg)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2024

Stimulation Therapy to Induce Mothers: Protocol for a Multicenter Randomized Controlled Trial.

Tortal et al. 2024JMIR research protocolscited by 2

PMID 39207839PMC11393510DOI 10.2196/63463PUB-39207839

CC BY

Download PDF

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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)

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