The Stimulation To Induce Mothers Study (STIM)

Yale University

Status and phase

Enrolling

Phase 4

Conditions

Induction of Labor Affected Fetus / Newborn

Physiologic Effects of Drugs

Labor Pain

Oxytocin

Treatments

Drug: Exogenous oxytocin intravenous infusion without nipple stimulation.

Device: Electric breast pump

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05079841

2000031338

231888-1 (Other Grant/Funding Number)

1R01HD111633-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Primary Objectives

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.
Breastfeeding as the sole source of nutrition at time of maternal hospital discharge

Secondary Objectives (if applicable)

The secondary objectives are as follows:

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.
Determine if women who perform intrapartum nipple stimulation to induce labor have differences in other obstetric and maternal outcomes
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.
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.
Maximal percent newborn weight loss during the birth hospitalization within 72 hours of life
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.
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.

Enrollment

988 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)