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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD111633-01 | U.S. NIH Grant/Contract | View source | |
| 231888-1 | Other Grant/Funding Number | Cornell University, Joan and Sanford I. Weill Medical College |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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, 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.
Primary Objectives
Secondary Objectives (if applicable)
The secondary objectives are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrapartum nipple stimulation | Experimental | Participants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor. |
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| Exogenous oxytocin intravenous infusion | Active Comparator | Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electric breast pump | Device | 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Subject-reported satisfaction during labor and childbirth |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moeun Son, MD, MSCI | Contact | (212) 746-2106 | mos7003@med.cornell.edu | |
| Molly McAdow, MD, PhD | Contact | molly.mcadow@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Molly McAdow, MD, PhD | Yale University | Principal Investigator |
| Bethany Stetson, MD | Northwestern University | Principal Investigator |
| Moeun Son, MD, MSCI |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 06510 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39207839 | Derived | Tortal D, Shabanova V, Taylor S, Xu X, McAdow M, Stetson B, McCollum S, Sanchez E, Adjakple A, Leventhal J, Son M. Stimulation Therapy to Induce Mothers: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 29;13:e63463. doi: 10.2196/63463. |
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De-identified data will be shared with academic researchers for secondary analyses or meta-analyses only after approval from the principal investigator and using an IRB-approved mechanism.
Data will become available after publication and will be available for 5 years.
De-identified data will be shared with academic researchers for secondary analyses or meta-analyses only after approval from the principal investigator and using an IRB-approved mechanism.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 11, 2025 | Mar 18, 2026 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 21, 2025 | Mar 16, 2026 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Exogenous oxytocin intravenous infusion without nipple stimulation. | Drug | Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor as current standard of care |
|
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| At delivery |
| Labor induction duration | Time interval from randomization to delivery | At delivery |
| 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 |
| 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 |
| 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 |
| Lactational mastitis | Subject-reported occurrence of lactational mastitis | After delivery to 12 weeks postpartum |
| Number of maternal deaths | Incidence of maternal death prior to, during, or post delivery | immediately prior to up to immediately post delivery |
| Maternal Intensive Care Unit admission | Any admission to the Intensive Care Unit after delivery and prior to delivery hospitalization discharge | 3-7 days postpartum |
| 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 |
| 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 |
| 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 |
| Percent newborn weight loss | Maximal percent newborn weight loss in kilograms(kg) | At 72 hours of life or birth hospitalization discharge, whichever is earlier |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Weill Medical College of Cornell University |
| Principal Investigator |
| Northwestern Memorial Hospital |
| Active, not recruiting |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |