Clinical trial NCT05079841: The Stimulation To Induce Mothers Study
Official title: The Stimulation To Induce Mothers (STIM) Study: A Parallel Group Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Oxytocin
Labor Pain
Induction of Labor Affected Fetus / Newborn
Physiologic Effects of Drugs
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-10-15
Enrollment: 988
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Spontaneous vaginal delivery
timeFrame: At delivery
measure: Breastfeeding as the sole source of nutrition (BSSN)
timeFrame: up to 72 hours following delivery
Secondary outcomes:
measure: Operative vaginal delivery
timeFrame: At delivery
measure: Cesarean delivery
timeFrame: At delivery
measure: Labor induction duration
timeFrame: At delivery
measure: Number of Participants with Postpartum hemorrhage
timeFrame: From delivery to 24 hours postpartum
measure: Number of Participants with Severe Postpartum hemorrhage
timeFrame: From delivery to 24 hours postpartum
measure: Number of participants with suspected infection
timeFrame: 3-7 days postpartum
measure: Lactational mastitis
timeFrame: After delivery to 12 weeks postpartum
measure: Number of maternal deaths
timeFrame: immediately prior to up to immediately post delivery
measure: Maternal Intensive Care Unit admission
timeFrame: 3-7 days postpartum
measure: Neonatal Intensive Care Unit admission
timeFrame: up to 28 days following birth
measure: Neonatal Apgar score ≤3 at 5 minutes of life
timeFrame: At 5 minutes after birth
measure: Umbilical acidemia
timeFrame: At delivery
measure: Composite neonatal severe morbidity measure
timeFrame: up to 28 days following delivery
measure: Percent newborn weight loss
timeFrame: At 72 hours of life or birth hospitalization discharge, whichever is earlier
Other outcomes:
measure: Subject-reported pain during childbirth
timeFrame: At intervention start and than again 2 hours after intervention start
measure: Subject-reported satisfaction during labor and childbirth
timeFrame: 6-96 hours after delivery
measure: Subject-reported feelings of control during labor and childbirth
timeFrame: 6-96 hours after delivery
measure: Subject-reported depression score
timeFrame: 4 to 12 weeks after delivery
measure: Subject-reported breastfeeding success
timeFrame: 4 to 12 weeks after delivery
measure: Subject-reported ability to express and/or collect colostrum and/or breastmilk intrapartum
timeFrame: From randomization to hospital discharge, approximately 3-7 days
measure: Subject-reported perception of milk supply
timeFrame: 2 weeks postpartum
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Yale University
name: Molly McAdow, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Bethany Stetson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Moeun Son, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References: