Your session is about to expire
← Back to Search
Hormone Therapy
Nipple Stimulation vs. Oxytocin Infusion for Inducing Labor (STIM Trial)
Phase 4
Recruiting
Led By Bethany Stetson, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Gestational age 36 0/7 weeks and greater at enrollment
Spontaneous rupture of membranes or if membranes intact, modified Bishop score ≥5 and cervix dilated <6 cm within one hour of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at delivery
Awards & highlights
STIM Trial Summary
This trial will compare the effects of intrapartum nipple stimulation versus exogenous oxytocin infusion for nulliparous women undergoing induction of labor near term. The primary hypothesis is that intrapartum nipple stimulation to induce labor increases spontaneous vaginal delivery.
Who is the study for?
This trial is for first-time mothers (nulliparous) who are at least 36 weeks pregnant, planning to start labor with oxytocin, and can consent. They must have a single baby in the correct position and not be in another study that affects labor or birth outcomes. Women with certain health conditions, previous nipple stimulation attempts, or planned cesarean deliveries cannot join.Check my eligibility
What is being tested?
The study compares two methods of inducing labor: using an electric breast pump to naturally stimulate labor versus giving synthetic oxytocin through an IV without nipple stimulation. The goal is to see which method leads to more natural births and better outcomes for mother and baby.See study design
What are the potential side effects?
Potential side effects from using the electric breast pump may include discomfort or soreness at the site of use. Synthetic oxytocin infusion might cause increased contractions leading to changes in fetal heart rate or other complications requiring medical attention.
STIM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 36 weeks pregnant.
Select...
My water has broken or I have a Bishop score ≥5 with cervix dilated <6 cm.
STIM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-96 hours after delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-96 hours after delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Breastfeeding as the sole source of nutrition (BSSN)
Spontaneous vaginal delivery
Secondary outcome measures
Cesarean delivery
Composite neonatal severe morbidity measure
Labor induction duration
+11 moreOther outcome measures
Subject-reported ability to express and/or collect colostrum and/or breastmilk intrapartum
Subject-reported breastfeeding success
Subject-reported depression score
+4 moreSTIM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intrapartum nipple stimulationExperimental Treatment1 Intervention
Participants randomized to the intrapartum nipple stimulation will use electric breast pump or stimulate by hand (intervention) to induce labor.
Group II: Exogenous oxytocin intravenous infusionActive Control1 Intervention
Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor.
Find a Location
Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,671,594 Total Patients Enrolled
Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,737,333 Total Patients Enrolled
2 Trials studying Labor Pain
117 Patients Enrolled for Labor Pain
Bethany Stetson, MDPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The baby is not positioned head-down in the womb when the study starts.I cannot use an electronic breast pump due to a mastectomy or other reasons.I am at least 36 weeks pregnant.You have had allergic reactions to parts of the electronic breast pump or to synthetic oxytocin given through a vein.I cannot understand English or Spanish.I am HIV positive.Suspected allergic reaction to blood transfusions.You have experienced certain abnormal changes in your baby's heart rate in the 30 minutes before joining the study.A serious problem with the baby is suspected before birth.My water has broken or I have a Bishop score ≥5 with cervix dilated <6 cm.You are pregnant with more than one baby (twins, triplets, etc.).The baby has passed away in the womb.You have a severe condition affecting the growth of an unborn baby or have abnormal umbilical artery tests.You are planning to start receiving oxytocin through an IV from your doctor during labor.I have severe difficulty thinking or staying awake.You have never given birth to a child.You are pregnant with only one baby.
Research Study Groups:
This trial has the following groups:- Group 1: Intrapartum nipple stimulation
- Group 2: Exogenous oxytocin intravenous infusion
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Electric breast pump met all safety criteria established by the FDA?
"Our team estimates the safety of electric breast pumps to be a 3, as Phase 4 trials denote that this method has already been approved."
Answered by AI
Is enrollment in the trial still accepting participants?
"As per clinicaltrials.gov, this trial is still accepting patients for participation. It was first advertised on November 15th 2021 and more recently updated on January 24th 2022."
Answered by AI
In what instances does a healthcare provider commonly recommend an electric breast pump?
"Electric breast pumps can assist with managing hemorrhaging, childbirth, and uterine contraction."
Answered by AI
How many subjects are enrolled in this trial?
"Affirmative. According to the clinicaltrials.gov website, this research trial is open for recruitment and began on November 15th 2021 before being updated most recently on January 24th 2022. It requires 562 participants from a single medical centre."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger