The Stimulation To Induce Mothers Study

Launched by YALE UNIVERSITY · Oct 14, 2021

Keywords

ClinConnect Summary

The Stimulation To Induce Mothers Study is a clinical trial designed to compare two methods for helping women who are about to give birth: nipple stimulation and a medication called oxytocin. Specifically, the trial focuses on first-time mothers (nulliparous women) who are near their due date and need assistance to start labor. The researchers want to find out if using nipple stimulation can lead to more successful vaginal births, improve overall satisfaction during labor, reduce pain, and lead to better health outcomes for both mothers and their newborns.

To participate in this trial, women need to be first-time mothers who are at least 36 weeks pregnant and are planning to start labor with oxytocin. They should also be having a single baby and meet certain health criteria. Participants will be randomly assigned to either the nipple stimulation or oxytocin group and will be monitored for various outcomes during their labor and delivery experience. It's essential to know that some women, such as those with specific pregnancy complications or who are not fluent in English or Spanish, may not be eligible to join the study.

Gender

FEMALE

Eligibility criteria

• 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)