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Home labor prep may cut C-Section rates in First-Time moms

NCT ID NCT05759988

Symptom relief Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
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.
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Paused for now. It may or may not start again.
Ongoing
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 Results may not be published yet.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)
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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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares starting labor induction at home versus in the hospital for first-time mothers carrying a single baby at full term. Participants will have a Foley catheter placed to help soften the cervix, then either go home or stay in the hospital. The goal is to see if the outpatient approach lowers the chance of needing a C-section and reduces health risks for mother and baby.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jun 2027

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 to 60 years

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 * Eligible for induction of labor * Live singleton gestation ≥37 weeks and \<42 weeks * Nulliparous, ≥18 years of age with no previous deliveries \>20 weeks * Cephalic presentation * Intact membranes * Bishop score ≤8 and cervical dilation \<3 cm * English or Spanish speaking (Able to read/understand consent and instructions) * Have reliable transportation to get back to the hospital and have a self-reported safe residence to go home to with the Foley catheter Exclusion Criteria * Known oligohydramnios (DVP \<2cm) * Known moderate-severe polyhydramnios (AFI ≥30 at time of delivery) * Concern regarding fetal status during antenatal testing: At provider discretion, but includes fetal decelerations, biophysical profile ≤6/10 * Vaginal bleeding or concern for/known abruption prior to Foley placement * Chorioamnionitis * Any fetal growth restriction * Preeclampsia with severe features * Severe chronic hypertension * Type 1 diabetes or poorly controlled pre-gestational diabetes * Sickle cell disease * Major fetal anomaly * Women on therapeutic anticoagulation * Decreased fetal movement * HIV Positive (rationale: HIV positive patients require an IV medication at the start of labor induction which cannot be given as an outpatient. There is universal testing of HIV in the 3rd trimester to verify this exclusion criteria) * Maternal cardiac disease requiring telemetry monitoring throughout induction/labor course

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As listed by the trial registrant

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

Induction of labor affected fetus / newborn

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Christiana Care Health Services, Inc.

    RECRUITING

    Newark, Delaware, 19718, United States

  • Intermountain Health Utah Valley Hospital

    RECRUITING

    Provo, Utah, 84604, United States

  • Princeton Medical Center

    RECRUITING

    Plainsboro, New Jersey, 08536, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas at Austin

    RECRUITING

    Austin, Texas, 78712, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

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