RECRUITING

The Stimulation To Induce Mothers Study

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Conditions

OxytocinLabor PainInduction of Labor Affected Fetus / NewbornPhysiologic Effects of Drugs

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-11-15
Study Completion:2029-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05079841

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Nulliparous
  2. * Gestational age 36 0/7 weeks and greater at enrollment
  3. * Singleton gestation
  4. * Planned to undergo initiation of exogenous oxytocin infusion by their maternity care provider
  5. * Spontaneous rupture of membranes or if membranes intact, modified Bishop score ≥5 and cervix dilated \<6 cm within one hour of enrollment
  6. * Ability to give informed consent
  1. * Unable to understand English or Spanish
  2. * Prior use of exogenous oxytocin or attempt at nipple stimulation during the current pregnancy
  3. * 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
  4. * Non-vertex presenting fetus at time of enrollment
  5. * Planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes infection, previous transmural myomectomy)
  6. * Multi-fetal gestation (e.g., twins, triplets, and higher-order multiples)
  7. * Intrauterine fetal death
  8. * Major fetal anomaly suspected prenatally (defined as a fetal anomaly with anticipated neonatal intensive care unit admission)
  9. * Suspected alloimmunization (given the increased likelihood for anticipated neonatal intensive care unit admission)
  10. * 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)
  11. * HIV infection (nipple stimulation is not encouraged given the recommendation for these mothers not to breastfeed)
  12. * Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality
  13. * History of mastectomy or other contraindication to use of electronic breast pump
  14. * Known allergic reactions to components of the electronic breast pump or to synthetic oxytocin intravenous solution
  15. * Significantly impaired consciousness or executive function (e.g., intubated or sedated)

Contacts and Locations

Study Contact

Moeun Son, MD, MSCI
CONTACT
(212) 746-2106
mos7003@med.cornell.edu
Jessica Leventhal, DNP
CONTACT
845-527-4979
jessica.leventhal@yale.edu

Principal Investigator

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 Locations (Sites)

Yale New Haven Hospital
New Haven, Connecticut, 06510
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Weill Cornell Medicine
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-15
Study Completion Date2029-03

Study Record Updates

Study Start Date2021-11-15
Study Completion Date2029-03

Terms related to this study

Additional Relevant MeSH Terms

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