Premature Rupture of Fetal MembranesNCT01736852
Evaluation of CRB in PROM Patients
A study testing CRB and Pitocin in people with Premature Rupture of Fetal Membranes, run by Cook Group Incorporated at 4 sites in United States.
Trial summary
The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premature Rupture of Fetal Membranes
- What is being tested?
- CRB and Pitocin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2012to 31 Dec 2018
- 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
- PROM not in labor
Who cannot join
- Contraindication to vaginal delivery
- Contraindication to labor induction
- Abnormal fetal heart-rate patterns
- Maternal heart disease
- Severe maternal hypertension
- Pelvic structural abnormality
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Kosair Children's Hospital Maternal Fetal Medicine Specialists
Louisville, Kentucky, 40202
University of South Florida
Tampa, Florida, 33606
Tucson Medical Center (TMC)
Tucson, Arizona, 85712
About this study
Official title: Randomized Study to Compare the Cook Cervical Ripening Balloon (CRB) Plus Pitocin to Pitocin Alone in Premature Rupture of Membranes (PROM) Patients
The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).
- Conditions
- Premature Rupture of Fetal Membranes
- Being tested
- CRB, Pitocin
- Keywords
- Premature Rupture of Membrane (Pregnancy), PROM, Cervical Ripening, Induced Labor
- 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.
CRBDevice
Labor induction using the CRB
PitocinDrug
Labor induction using Pitocin
| Study group | Role | What they receive |
|---|---|---|
| CRB plus Pitocin | Experimental | Not described Receives: Device: CRB; Drug: Pitocin |
| Pitocin | Active comparator | Not described Receives: Drug: Pitocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Labor
Time, in minutes, from the start of labor induction through delivery
Measured: Start of labor induction through delivery, an expected average of 6 hours
Incidence of Infection
number of patients with chorioamnionitis
Measured: Through hospital discharge, an expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startNov 2012
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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 Premature Rupture of Fetal MembranesStudies of the same condition, open and under way.
- 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugh Miller, MD, Principal investigator, Watching Over Mothers and Babies (WOMB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736852
- Sponsor's protocol ID
- 09-014
- Status last verified
- Oct 2020
- First submitted
- 6 Sep 2012
- Last updated
- 20 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Undecided: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Publications
Hessami K, Tounsi S, Gandhi M, Turrentine MA. Risk of Intra-Amniotic Infection After Cervical Ripening Balloon for Prelabor Rupture of Membranes: A Systematic Review and Meta-analysis. Obstet Gynecol. 2026 Jul 9. doi: 10.1097/AOG.0000000000006362. Online ahead of print.
PubMed 42424638
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study to Compare the Cook Cervical Ripening Balloon (CRB) Plus Pitocin to Pitocin Alone in Premature Rupture of Membranes (PROM) Patients
- ClinicalTrials.gov ID
- NCT01736852
- Acronym / sponsor ID
- 09-014
- Conditions
- Premature Rupture of Fetal Membranes
- Keywords
- Premature Rupture of Membrane (Pregnancy), PROM, Cervical Ripening, Induced Labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2012 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Posted 20 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CRB study is designed to study the safety and effectiveness of the Cook Cervical Ripening Balloon (CRB) for the induction of labor in term and near-term patients with premature rupture of membranes (PROM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRB plus Pitocin | Experimental | Device: CRB, Drug: Pitocin |
| Pitocin | Active comparator | Drug: Pitocin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PROM not in labor
Key exclusion criteria (6 listed)
- Contraindication to vaginal delivery
- Contraindication to labor induction
- Abnormal fetal heart-rate patterns
- Maternal heart disease
- Severe maternal hypertension
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 |
|---|---|---|
| CRBLabor induction using the CRB | Device | CRB plus Pitocin |
| PitocinLabor induction using Pitocin | Drug | CRB plus Pitocin, Pitocin |
Primary outcome
Time of Labor
Time frame: Start of labor induction through delivery, an expected average of 6 hours
Time, in minutes, from the start of labor induction through delivery
Incidence of Infection
Time frame: Through hospital discharge, an expected average of 3 days
number of patients with chorioamnionitis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42424638Hessami K, Tounsi S, Gandhi M, Turrentine MA. Risk of Intra-Amniotic Infection After Cervical Ripening Balloon for Prelabor Rupture of Membranes: A Systematic Review and Meta-analysis. Obstet Gynecol. 2026 Jul 9. doi: 10.1097/AOG.0000000000006362. Online ahead of print.
- Individual participant dataSharing planned: Undecided. Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after publication of the results from this study and ending 5 years after initial publication. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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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.
Hugh Miller, MD principal investigator
Watching Over Mothers and Babies (WOMB)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRB and Pitocin in people with Premature Rupture of Fetal Membranes, run by Cook Group Incorporated at 4 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 1 inclusion and 6 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 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 20 Oct 2020). 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 of Labor (time frame: Start of labor induction through delivery, an expected average of 6 hours). The study lists 2 primary outcomes in all. 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 NCT01736852, 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 20 Oct 2020.