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Breast pump vs. pitocin: a natural way to induce labor?

NCT ID NCT05079841

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This study compares using an electric breast pump (or hand stimulation) to standard oxytocin infusion for inducing labor in nearly 1,000 first-time mothers. The goal is to see if nipple stimulation leads to more spontaneous vaginal deliveries and better experiences for moms and babies. Researchers will also measure oxytocin levels in a smaller group to understand how the body responds.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
electric breast pump (nipple stimulation)
What this could lead to
If it works, this could offer a drug-free, more natural way to start labor for first-time mothers, potentially reducing the need for medical interventions like Pitocin.
What could go wrong
This is a Phase 4 study, but it's still early to know if nipple stimulation is as effective or safe as standard oxytocin. Results may not apply to all women, and there is a risk that labor may not progress as needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

933 people

The number who actually took part.

Started

Nov 2021

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Labor Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

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