The Stimulation To Induce Mothers Study

ConditionsOxytocin Labor Pain Induction of Labor Affected Fetus / Newborn Physiologic Effects of Drugs

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age18+

SponsorYale University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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
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

Treatment groups

988 Participants

are divided into 2 treatment groups

Group A: Intrapartum nipple stimulationExperimental treatment 1 intervention

Group B: Exogenous oxytocin intravenous infusionActive comparator 1 intervention

Trial outcomes

Primary outcomes

Spontaneous vaginal delivery

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

Time frame

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)

Time frame

up to 72 hours following delivery

Secondary outcomes

Operative vaginal delivery

Delivery with the assistance of forceps or vacuum, and indication

Time frame

At delivery

Cesarean delivery

Delivery by cesarean section

Time frame

At delivery

Labor induction duration

Time interval from randomization to delivery

Time frame

At delivery

Number of Participants with Postpartum hemorrhage

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

Time frame

From delivery to 24 hours postpartum

Other outcomes

Subject-reported pain during childbirth

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

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)

Time frame

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)

Time frame

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

Time frame

4 to 12 weeks after delivery