Fetal Membranes, Premature RuptureNCT00290199
Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture
A study testing Transcervical Foley catheter in people with Fetal Membranes, Premature Rupture and Labor, Induced/IS, run by University of Alabama at Birmingham at 3 sites in United States.
Trial summary
In women undergoing labor induction for membrane rupture at or near term, we are investigating the addition of a foley catheter placed in the cervix to standard therapy (oxytocin administration) to decrease the time from the start of the induction to delivery. Read more about this study
- Who is it for?
- Ages 12 to 55 years, women only
- Conditions the study is for
- Fetal Membranes, Premature Rupture, Labor, Induced/IS
- What is being tested?
- Transcervical Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2005to May 2008
- 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 12 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Preterm rupture of membranes (PROM) (Rupture of membranes = pooling/ferning/nitrazine +) Rupture of membranes (ROM) for ≥1 hour prior to starting induction
- Cervix ≤ 2 centimeters (cm)
- Gestational age ≥ 34 weeks by best obstetric estimate and clinical management decision is delivery
- Singleton gestation
- Cephalic
- Vertex well applied to cervix
Who cannot join
- Regular uterine contractions (contractions more frequent than every 5 minutes)
- Two prior transverse uterine incisions/vertical uterine incision/ transmural myomectomy or any obstetric contraindication to labor
- Evidence of chorioamnionitis (temperature of 100.4°F with uterine tenderness and maternal or fetal tachycardia or purulent discharge)
- Lethal fetal anomalies
- Intrauterine fetal demise (IUFD)
- Previa
Show all 9Show fewer
- Suspected abruption/significant hemorrhage
- Non-reassuring fetal heart rate (FHR) pattern
- Non vertex fetal presentation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Greenville Hospital System University Medical Center
Greenville, South Carolina, 29605
Christiana Care Health System
Newark, Delaware, 19713
About this study
Official title: A Randomized Controlled Trial of Foley Catheter for Labor Induction in Women With Term and Near Term Prelabor Rupture of Membranes (PROM)
In women undergoing labor induction for membrane rupture at or near term, we are investigating the addition of a foley catheter placed in the cervix to standard therapy (oxytocin administration) to decrease the time from the start of the induction to delivery.
Read the detailed description
To compare the efficacy of a transcervical Foley catheter with concurrent oxytocin administration compared to oxytocin infusion alone for cervical ripening and labor induction in women with premature rupture of membranes (PROM) at > 34 weeks.
- Being tested
- Transcervical Foley catheter
- Keywords
- Fetal Membranes, Premature Rupture, Labor, Induced, Foley Catheter
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcervical Foley catheterDevice
Foley catheter placed through cervix for cervical ripening
| Study group | Role | What they receive |
|---|---|---|
| Transcervical Foley Catheter | Experimental | Not described Receives: Device: Transcervical Foley catheter |
| No Foley | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours From Placement of Foley or Initiation of Oxytocin to Delivery
The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours)
Measured: Time from induction to delivery
Secondary outcomes (3)
Rate of Delivery (Vaginal or Cesarean)by 24 Hours
The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours.
Measured: from start of induction to 24 hours post start of induction
Cesarean Rate
The percent of subjects enrolled who had a cesarean at any time for any reason for delivery.
Measured: at delivery
Induction to Vaginal Delivery Interval
Mean hours from time of induction to vaginal delivery interval.
Measured: time from induction to vaginal delivery, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startDec 2005
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: Gathering information from the PI records to provide this response.
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 (2)Papers the sponsor has linked to this study.
- Other trials for Fetal Membranes, Premature RuptureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Tita, University of Alabama at Birmingham
- Investigators
- Alan T Tita, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290199
- Sponsor's protocol ID
- F051021005
- Status last verified
- Apr 2017
- First submitted
- 9 Feb 2006
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wolff K, Swahn ML, Westgren M. Balloon catheter for induction of labor in nulliparous women with prelabor rupture of the membranes at term. A preliminary report. Gynecol Obstet Invest. 1998;46(1):1-4. doi: 10.1159/000009986.
PubMed 9692332de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Foley Catheter for Labor Induction in Women With Term and Near Term Prelabor Rupture of Membranes (PROM)
- ClinicalTrials.gov ID
- NCT00290199
- Acronym / sponsor ID
- F051021005
- Keywords
- Fetal Membranes, Premature Rupture, Labor, Induced, Foley Catheter
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Gathering information from the PI records to provide this response.
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 10 Feb 2006 (estimated)
- Results
- Posted 31 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In women undergoing labor induction for membrane rupture at or near term, we are investigating the addition of a foley catheter placed in the cervix to standard therapy (oxytocin administration) to decrease the time from the start of the induction to delivery.
Detailed description
To compare the efficacy of a transcervical Foley catheter with concurrent oxytocin administration compared to oxytocin infusion alone for cervical ripening and labor induction in women with premature rupture of membranes (PROM) at > 34 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcervical Foley Catheter | Experimental | Device: Transcervical Foley catheter |
| No Foley | No intervention | – |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Preterm rupture of membranes (PROM) (Rupture of membranes = pooling/ferning/nitrazine +) Rupture of membranes (ROM) for ≥1 hour prior to starting induction
- Cervix ≤ 2 centimeters (cm)
- Gestational age ≥ 34 weeks by best obstetric estimate and clinical management decision is delivery
- Singleton gestation
- Cephalic
Key exclusion criteria (9 listed)
- Regular uterine contractions (contractions more frequent than every 5 minutes)
- Two prior transverse uterine incisions/vertical uterine incision/ transmural myomectomy or any obstetric contraindication to labor
- Evidence of chorioamnionitis (temperature of 100.4°F with uterine tenderness and maternal or fetal tachycardia or purulent discharge)
- Lethal fetal anomalies
- Intrauterine fetal demise (IUFD)
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 |
|---|---|---|
| Transcervical Foley catheterFoley catheter placed through cervix for cervical ripening | Device | Transcervical Foley Catheter |
Primary outcome
Hours From Placement of Foley or Initiation of Oxytocin to Delivery
Time frame: Time from induction to delivery
The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours)
3 secondary outcomes
Rate of Delivery (Vaginal or Cesarean)by 24 Hours
Time frame: from start of induction to 24 hours post start of induction
Cesarean Rate
Time frame: at delivery
Induction to Vaginal Delivery Interval
Time frame: time from induction to vaginal delivery, up to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9692332Wolff K, Swahn ML, Westgren M. Balloon catheter for induction of labor in nulliparous women with prelabor rupture of the membranes at term. A preliminary report. Gynecol Obstet Invest. 1998;46(1):1-4. doi: 10.1159/000009986.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
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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.
Alan T Tita, MD principal investigator
University of Alabama at Birmingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcervical Foley catheter in people with Fetal Membranes, Premature Rupture and Labor, Induced/IS, run by University of Alabama at Birmingham at 3 sites 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 31 Oct 2012). 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?
Hours From Placement of Foley or Initiation of Oxytocin to Delivery (time frame: Time from induction to 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 NCT00290199, which also lists 2 linked publications.
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 23 May 2017.