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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05079841
Other study ID # 2000031338
Secondary ID 1R01HD111633-012
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 15, 2021
Est. completion date March 2029

Study information

Verified date January 2024
Source Yale University
Contact Moeun Son, MD, MSCI
Phone (212) 746-2106
Email mos7003@med.cornell.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 988
Est. completion date March 2029
Est. primary completion date November 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Electric breast pump
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
Drug:
Exogenous oxytocin intravenous infusion without nipple stimulation.
Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor as current standard of care

Locations

Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois
United States Yale New Haven Hospital New Haven Connecticut
United States Weill Cornell Medicine New York New York

Sponsors (2)

Lead Sponsor Collaborator
Yale University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Subject-reported pain during childbirth Visual analog scale, scored with Likert scale from 0 (no pain) to 10 (worst pain) At intervention start and than again 2 hours after intervention start
Other Subject-reported satisfaction during labor and childbirth Birth Satisfaction Scale-Revised (BSS-R) is a 10-item self-report valid and reliable measure (scores range from 0 to 40, 0 being the least satisfaction and 40 being the most satisfaction) 6-96 hours after delivery
Other Subject-reported feelings of control during labor and childbirth Labor Agentry Scale is a 29-item survey designed to assess expectations and experiences of personal control during childbirth (scores range from 29 to 203, with higher scores indicating greater perceived control during childbirth) 6-96 hours after delivery
Other Subject-reported depression score Edinburgh Postnatal Depression Scale is a 10-item self report scored from 0 to 30; score >10 warrants additional clinical assessment for depression 4 to 12 weeks after delivery
Other Subject-reported breastfeeding success Maternal Breastfeeding Evaluation Scale (MBES) is a 30-item using a 5-point Likert scale with higher scores reflecting more positive breastfeeding experiences. 4 to 12 weeks after delivery
Other Subject-reported ability to express and/or collect colostrum and/or breastmilk intrapartum Participants ability to express and/or collect colostrum and/or breastmilk intrapartum From randomization to hospital discharge, approximately 3-7 days
Other Subject-reported perception of milk supply Subject-reported perception of milk supply using the validated Perception of Insufficient Milk Supply (PIMS). PIM is defined as a state in which a mother has or perceives that she has an inadequate supply of breast milk to meet her infant's needs. A perception of insufficient milk supply is associated with early discontinuation of breastfeeding. 2 weeks postpartum
Primary Spontaneous vaginal delivery Spontaneous vaginal delivery will be defined as delivery that occurs without the use of forceps, vacuum, or cesarean At delivery
Primary Breastfeeding as the sole source of nutrition (BSSN) Number of participants using breastfeeding as the sole source of nutrition (BSSN) at time of maternal discharge or 72 hours of life (whichever is sooner) up to 72 hours following delivery
Secondary Operative vaginal delivery Delivery with the assistance of forceps or vacuum, and indication At delivery
Secondary Cesarean delivery Delivery by cesarean section At delivery
Secondary Labor induction duration Time interval from randomization to delivery At delivery
Secondary Number of Participants with Postpartum hemorrhage Cumulative blood loss of =1,000 mL within 24 hours after the birth process From delivery to 24 hours postpartum
Secondary Number of Participants with Severe Postpartum hemorrhage Transfusion; non-elective hysterectomy; use of =2 uterotonic medications other than oxytocin; other interventions such as uterine compression sutures, uterine artery ligation or embolization, hypogastric artery ligation, balloon tamponade From delivery to 24 hours postpartum
Secondary Number of participants with suspected infection Suspected intraamniotic infection, intrapartum chorioamnionitis, or postpartum endometritis (defined as maternal fever =38° Fahrenheit with planned or initiated administration of therapeutic antibiotics) after randomization and prior to delivery hospitalization discharge 3-7 days postpartum
Secondary Lactational mastitis Subject-reported occurrence of lactational mastitis After delivery to 12 weeks postpartum
Secondary Number of maternal deaths Incidence of maternal death prior to, during, or post delivery immediately prior to up to immediately post delivery
Secondary Maternal Intensive Care Unit admission Any admission to the Intensive Care Unit after delivery and prior to delivery hospitalization discharge 3-7 days postpartum
Secondary Neonatal Intensive Care Unit admission Any admission to the Neonatal Intensive Care Unit From birth to birth hospitalization discharge or 28 days after birth, whichever is earlier up to 28 days following birth
Secondary 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
Secondary 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
Secondary 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
Secondary Percent newborn weight loss Maximal percent newborn weight loss in kilograms(kg) At 72 hours of life or birth hospitalization discharge, whichever is earlier
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