The Stimulation To Induce Mothers Study

Description

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.

Conditions

Oxytocin, Labor Pain, Induction of Labor Affected Fetus / Newborn, Physiologic Effects of Drugs

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Study Overview

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Study Details

Study overview

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.

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

The Stimulation To Induce Mothers Study

Condition
Oxytocin
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Hospital, New Haven, Connecticut, United States, 06510

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

New York

Weill Cornell Medicine, New York, New York, United States, 10065

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Yale University,

Molly McAdow, MD, PRINCIPAL_INVESTIGATOR, Yale University

Bethany Stetson, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Moeun Son, MD, MSCI, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2029-03