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New treatment option for Oxytocin
Official title The Stimulation To Induce Mothers Study
ClinicalTrials.gov ID: NCT05079841
What this study is testing
What is Exogenous oxytocin intravenous infusion without nipple stimulation.?
Exogenous oxytocin intravenous infusion without nipple stimulation. is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for oxytocin.
Also referred to as Pitocin intravenous infusion.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Multi-fetal gestation (e.g., twins, triplets, and higher-order multiples)
See the full eligibility 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
- 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 treatment 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)
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Chicago, Illinois, United States
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Chicago, Illinois, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.