The Stimulation To Induce Mothers Study

Phase 4

Recruiting

• Conditions: Oxytocin; Labor Pain; Physiologic Effects of Drugs; Induction of Labor Affected Fetus / Newborn
• Interventions: Device: Electric breast pump; Drug: Exogenous oxytocin intravenous infusion without nipple stimulation.

• Registration Number: NCT05079841
• Lead Sponsor: Yale University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-15
• Study Start: 2021-11-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2028-11
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 988

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrapartum nipple stimulation	Electric breast pump	Participants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor.
Exogenous oxytocin intravenous infusion	Exogenous oxytocin intravenous infusion without nipple stimulation.	Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor.

Primary Outcome Measures

Name	Time	Method
Spontaneous vaginal delivery	At delivery	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)	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)

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States