The Stimulation To Induce Mothers Study

Study Overview
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Brief Summary
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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 (Primary Aim), 2) Determine the effect of intrapartum nipple stimulation on the rate of adverse maternal and neonatal outcomes (Secondary Aim #1), 3) Determine the impact of intrapartum nipple stimulation on patient-centered outcomes (Secondary Aim #2) and 4) In a sub-cohort of women who are enrolled in the trial, to measure the change in oxytocin concentration from baseline to time at which patient achieves a regular contraction pattern, and to measure correlation between salivary and serum oxytocin concentrations in patients undergoing induction of labor via intrapartum nipple stimulation versus continuous exogenous oxytocin infusion. The investigators estimate that randomizing a total of 562 women will provide adequate statistical power to detect meaningful differences in the primary outcome.

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

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

Intervention / Treatment
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* Device: Electric breast pump
* Drug: Exogenous oxytocin intravenous infusion without nipple stimulation.


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrapartum nipple stimulation<br>Participants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor. | Device: Electric breast pump<br>* Participants randomized to the intrapartum nipple stimulation will use electric breast pump or nipple stimulate by hand (if preferred) (intervention) to induce labor for at least 2 hours<br>* Other names: Medela Symphony pump;|
| Active Comparator: Exogenous oxytocin intravenous infusion<br>Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor. | Drug: Exogenous oxytocin intravenous infusion without nipple stimulation.<br>* Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor<br>* Other names: Pitocin intravenous infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous vaginal delivery | Spontaneous vaginal delivery will be defined as delivery that occurs without the use of forceps, vacuum, or cesarean | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative vaginal delivery | Delivery with the assistance of forceps or vacuum, and indication | At delivery | 
| Cesarean delivery | Delivery by cesarean section | At delivery | 
| Labor induction duration | Time interval from randomization to delivery | At delivery | 
| Postpartum hemorrhage | Cumulative blood loss of ≥1,000 mL within 24 hours after the birth process | From delivery to 24 hours postpartum | 
| Neonatal Apgar score ≤3 at 5 minutes of life | The Neonatal Apgar score is scored from 0 to 10. A 5-minute Apgar score of 0-3 correlates with neonatal mortality in large population studies. | At 5 minutes after birth | 
| Umbilical acidemia | Umbilical cord arterial pH <7.0 or base excess >12 mmol/L; or umbilical cord venous pH <7.0 or base excess >12 mmol/L if arterial blood sample not available | At delivery | 
| Neonatal Intensive Care Unit admission | Any admission to the Neonatal Intensive Care Unit from delivery until birth hospitalization discharge or neonatal death up to 28 days of life | up to 28 days following delivery | 
| Composite neonatal severe morbidity measure | Intrapartum fetal death or neonatal death; cardiorespiratory support within first 72 hours of life; neonatal encephalopathy; seizures; hypothermic treatment (cooling); sepsis; pneumonia; major birth injury; meconium aspiration syndrome; intracranial hemorrhage or subgaleal hemorrhage; or hypotension requiring pressor support | up to 28 days following delivery | 
| Lactational mastitis | Subject-reported occurrence of lactational mastitis | After delivery to 12 weeks postpartum |