Labor InductionNCT04573517
Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor
A study testing Amniotomy and Foley balloon in people with Labor Induction and Early Amniotomy, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Induction, Early Amniotomy
- What is being tested?
- Amniotomy and Foley balloon
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 22 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18
- Singleton pregnancy
- Term gestation (37 weeks gestation)
- Cephalic presentation
- Undergoing labor induction with transcervical Foley balloon
Who cannot join
- Previous uterine surgery
- Prelabor rupture of membranes
- Severe pre-eclampsia, HELLP, or eclampsia
- HIV, HCV, or HBV
- Heart disease
- Fever (≥38 0C) at admission
Show all 12Show fewer
- Category II or III fetal heart rate tracing prior to randomization
- Polyhydramnios
- Fetal growth restriction <3%
- EFW > 4200 g
- Fetal demise or major congenital anomaly
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77550
About this study
Official title: Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor: a Randomized Clinical Trial
Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, however, that reports an increase in cesarean deliveries with early amniotomy. Due to the small number of studies evaluating this topic, as well as the conflicting results, more research is needed. Additionally, the method of cervical ripening prior to amniotomy should be accounted for, as it may have an impact on the overall labor course. The purpose of this study is to evaluate the impact of early versus delayed amniotomy on time of delivery time from induction to the active phase of labor, as well on total time to delivery and maternal and neonatal outcomes in women undergoing cervical ripening with the Foley balloon.
Read the detailed description
This will be an unblinded randomized clinical trial. The investigators will recruit 174 pregnant women undergoing induction of labor. Recruitment will occur on the Labor and Delivery unit at the time of induction, after the decision has been made to place a Foley balloon for cervical ripening. Enrolled subjects will be randomized to early or delayed amniotomy.
Subjects randomized to early amniotomy will undergo amniotomy within 2 hours of Foley balloon removal. Subjects randomized to delayed amniotomy will undergo amniotomy at least 4 hours after Foley balloon removal.
- Conditions
- Labor Induction, Early Amniotomy
- Being tested
- Amniotomy, Foley balloon
- Keywords
- Foley balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmniotomyProcedure or surgery
Artificial rupture of amniotic membranes
Foley balloonDevice
Also called Foley catheter, Foley bulb
The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Early amniotomy | Experimental | Subjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon. Receives: Procedure: Amniotomy; Device: Foley balloon |
| Delayed amniotomy | Active comparator | Subjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon. Receives: Procedure: Amniotomy; Device: Foley balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Active Phase of Labor
Total time from initiation of labor induction to reaching 6 cm cervical dilation
Measured: At delivery
Secondary outcomes (6)
Time to Delivery
Total time from initiation of labor induction to delivery
Measured: At delivery
Vaginal Delivery Rate
Rate of vaginal delivery within 24, 36, and 48 hours
Measured: At delivery
Cesarean Section Rate
Rate of cesarean section and indications
Measured: At delivery
Maternal Infection Composite
Includes isolated maternal fever, chorioamnionitis, endometritis, wound infection
Measured: From admission to discharge, up to 2 weeks
Umbilical Cord Prolapse
Rates of umbilical cord prolapse
Measured: At delivery
Neonatal Outcome Composite
Neonatal outcome composite including NICU admission, respiratory support, hypoxic ischemic encephalopathy, seizures, sepsis, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, hypotension requiring pressors, and perinatal death.
Measured: From admission to discharge, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start15 Oct 2020
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor InductionStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marissa Berry, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573517
- Sponsor's protocol ID
- 20-0163
- Status last verified
- Feb 2025
- First submitted
- 22 Sep 2020
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berry M, Lamiman K, Slan MN, Zhang X, Arena Goncharov DD, Hwang YP, Rogers JA, Pacheco LD, Saade GR, Saad AF. Early vs delayed amniotomy following transcervical Foley balloon in the induction of labor: a randomized clinical trial. Am J Obstet Gynecol. 2024 May;230(5):567.e1-567.e11. doi: 10.1016/j.ajog.2024.01.028. Epub 2024 Feb 15.
PubMed 38367749
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04573517
- Acronym / sponsor ID
- 20-0163
- Conditions
- Labor Induction, Early Amniotomy
- Keywords
- Foley balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, however, that reports an increase in cesarean deliveries with early amniotomy. Due to the small number of studies evaluating this topic, as well as the conflicting results, more research is needed. Additionally, the method of cervical ripening prior to amniotomy should be accounted for, as it may have an impact on the overall labor course. The purpose of this study is to evaluate the impact of early versus delayed amniotomy on time of delivery time from induction to the active phase of labor, as well on total time to delivery and maternal and neonatal outcomes in women undergoing cervical ripening with the Foley balloon.
Detailed description
This will be an unblinded randomized clinical trial. The investigators will recruit 174 pregnant women undergoing induction of labor. Recruitment will occur on the Labor and Delivery unit at the time of induction, after the decision has been made to place a Foley balloon for cervical ripening. Enrolled subjects will be randomized to early or delayed amniotomy.
Subjects randomized to early amniotomy will undergo amniotomy within 2 hours of Foley balloon removal. Subjects randomized to delayed amniotomy will undergo amniotomy at least 4 hours after Foley balloon removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early amniotomy | Experimental | Procedure: Amniotomy, Device: Foley balloonSubjects randomized to this arm will undergo amniotomy within 2 hours of removal of Foley balloon. |
| Delayed amniotomy | Active comparator | Procedure: Amniotomy, Device: Foley balloonSubjects randomized to this arm will undergo amniotomy at least 4 hours after removal of Foley balloon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18
- Singleton pregnancy
- Term gestation (37 weeks gestation)
- Cephalic presentation
- Undergoing labor induction with transcervical Foley balloon
Key exclusion criteria (12 listed)
- Previous uterine surgery
- Prelabor rupture of membranes
- Severe pre-eclampsia, HELLP, or eclampsia
- HIV, HCV, or HBV
- Heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmniotomyArtificial rupture of amniotic membranes | Procedure or surgery | Delayed amniotomy, Early amniotomy |
| Foley balloonAlso: Foley catheter, Foley bulbThe Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours. | Device | Delayed amniotomy, Early amniotomy |
Primary outcome
Time to Active Phase of Labor
Time frame: At delivery
Total time from initiation of labor induction to reaching 6 cm cervical dilation
6 secondary outcomes
Time to Delivery
Time frame: At delivery
Vaginal Delivery Rate
Time frame: At delivery
Cesarean Section Rate
Time frame: At delivery
Maternal Infection Composite
Time frame: From admission to discharge, up to 2 weeks
Umbilical Cord Prolapse
Time frame: At delivery
Neonatal Outcome Composite
Time frame: From admission to discharge, up to 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38367749Berry M, Lamiman K, Slan MN, Zhang X, Arena Goncharov DD, Hwang YP, Rogers JA, Pacheco LD, Saade GR, Saad AF. Early vs delayed amniotomy following transcervical Foley balloon in the induction of labor: a randomized clinical trial. Am J Obstet Gynecol. 2024 May;230(5):567.e1-567.e11. doi: 10.1016/j.ajog.2024.01.028. Epub 2024 Feb 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marissa Berry, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amniotomy and Foley balloon in people with Labor Induction and Early Amniotomy, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Active Phase of Labor (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04573517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.