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The Stimulation To Induce Mothers Study (STIM)

Primary Purpose

Oxytocin, Labor Pain, Induction of Labor Affected Fetus / Newborn

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Electric breast pump

Exogenous oxytocin intravenous infusion without nipple stimulation.

About this trial

This is an interventional other trial for Oxytocin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

Yale New Haven HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intrapartum nipple stimulation

Exogenous oxytocin intravenous infusion

Arm Description

Participants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor.

Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor.

Outcomes

Primary Outcome Measures

Spontaneous vaginal delivery

Spontaneous vaginal delivery will be defined as delivery that occurs without the use of forceps, vacuum, or cesarean

Secondary Outcome Measures

Operative vaginal delivery

Delivery with the assistance of forceps or vacuum, and indication

Cesarean delivery

Delivery by cesarean section

Labor induction duration

Time interval from randomization to delivery

Postpartum hemorrhage

Cumulative blood loss of ≥1,000 mL within 24 hours after the birth process

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.

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

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

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

Lactational mastitis

Subject-reported occurrence of lactational mastitis

Full Information

NCT ID

NCT05079841

First Posted

September 20, 2021

Last Updated

May 22, 2023

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT05079841

Brief Title

The Stimulation To Induce Mothers Study

Acronym

STIM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 15, 2021 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

988 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intrapartum nipple stimulation

Arm Type

Experimental

Arm Description

Participants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor.

Arm Title

Exogenous oxytocin intravenous infusion

Arm Type

Active Comparator

Arm Description

Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor.

Intervention Type

Device

Intervention Name(s)

Electric breast pump

Other Intervention Name(s)

Medela Symphony pump

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Exogenous oxytocin intravenous infusion without nipple stimulation.

Other Intervention Name(s)

Pitocin intravenous infusion

Intervention Description

Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor

Primary Outcome Measure Information:

Title

Spontaneous vaginal delivery

Description

Spontaneous vaginal delivery will be defined as delivery that occurs without the use of forceps, vacuum, or cesarean

Time Frame

At delivery

Secondary Outcome Measure Information:

Title

Operative vaginal delivery

Description

Delivery with the assistance of forceps or vacuum, and indication

Time Frame

At delivery

Title

Cesarean delivery

Description

Delivery by cesarean section

Time Frame

At delivery

Title

Labor induction duration

Description

Time interval from randomization to delivery

Time Frame

At delivery

Title

Postpartum hemorrhage

Description

Cumulative blood loss of ≥1,000 mL within 24 hours after the birth process

Time Frame

From delivery to 24 hours postpartum

Title

Neonatal Apgar score ≤3 at 5 minutes of life

Description

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.

Time Frame

At 5 minutes after birth

Title

Umbilical acidemia

Description

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

Time Frame

At delivery

Title

Neonatal Intensive Care Unit admission

Description

Any admission to the Neonatal Intensive Care Unit from delivery until birth hospitalization discharge or neonatal death up to 28 days of life

Time Frame

up to 28 days following delivery

Title

Composite neonatal severe morbidity measure

Description

Time Frame

up to 28 days following delivery

Title

Lactational mastitis

Description

Subject-reported occurrence of lactational mastitis

Time Frame

After delivery to 12 weeks postpartum

Other Pre-specified Outcome Measures:

Title

Subject-reported pain during childbirth

Description

Visual analog scale, scored with Likert scale from 0 (no pain) to 10 (worst pain)

Time Frame

At intervention start and than again 2 hours after intervention start

Title

Subject-reported satisfaction during labor and childbirth

Description

Birth Satisfaction Scale-Revised 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)

Time Frame

6-96 hours after delivery

Title

Subject-reported feelings of control during labor and childbirth

Description

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)

Time Frame

6-96 hours after delivery

Title

Subject-reported depression score

Description

Edinburgh Postnatal Depression Scale is a 10-item self report scored from 0 to 30; score >10 warrants additional clinical assessment for depression

Time Frame

4 to 12 weeks after delivery

Title

Subject-reported breastfeeding success

Description

Maternal Breastfeeding Evaluation Scale (MBFES) is a 30-item using a 5-point Likert scale with higher scores reflecting more positive breastfeeding experiences.

Time Frame

4 to 12 weeks after delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Moeun Son, MD, MSCI

Phone

203-785-2671

moeun.son@yale.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Danna Tortal, BA

danna.tortal@yale.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moeun Son, MD, MSCI

Organizational Affiliation

Yale University, Yale School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale New Haven Hospital

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Moeun Son, MD, MSCI

moeun.son@yale.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

Data will become available after publication and will be available for 5 years.

IPD Sharing Access Criteria

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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The Stimulation To Induce Mothers Study

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