Labor InductionNCT00504465
Combined Agent Randomized Trial of Induction of Labor
A study testing dinoprostone in people with Labor Induction and Cervical Ripening, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial summary
To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from smaller trials and add to data on fetal safety. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Labor Induction, Cervical Ripening
- What is being tested?
- dinoprostone
- How many people
- 210 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2002to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- > or = to 36 weeks of gestation
- Singleton fetus
- Cephalic presentation
- Intact membranes and an unripe cervix (Bishop score <6)
Who cannot join
- Multifetal gestation
- Rupture of membranes
- Ripe cervix (Bishop score >6)
- Active labor
- Contraindication to vaginal delivery
- Previous uterine surgery
- Non-cephalic presentation
- Fetal macrosomia
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Brooklyn Hospital Center
Brooklyn, New York, 11201
New York Hospital Medical Center of Queens
Flushing, New York, 11355
Weill Medical College of Cornell University
New York, New York, 10021
About this study
Official title: Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin.
To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from smaller trials and add to data on fetal safety.
Read the detailed description
This study is a non-blinded, three arm randomized trial at 3 sites. Entry criteria were: >36 weeks' singleton, cephalic gestation with intact membranes and an unripe cervix (Bishop's score <6). Study arms were: 1) dinoprostone vaginal insert (Cervidil) for 12 hours followed by oxytocin, 2) dinoprostone vaginal insert (Cervidil) for 12 hours with simultaneous oxytocin, and 3) intracervical dinoprostone gel (Prepidil)(one dose) followed by immediate oxytocin. Primary outcome measure was the rate of vaginal delivery <24 hours. Secondary outcomes were randomization to delivery interval, rate of cesarean delivery (CD) for non reassuring fetal status (NRFS) and rate of uterine hyperstimulation.
- Conditions
- Labor Induction, Cervical Ripening
- Being tested
- dinoprostone
- Keywords
- Labor, Labor induction, Cervical ripening, Dinoprostone, Fetal safety, Oxytocin, Cesarean delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dinoprostoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of vaginal delivery <24 hours
Secondary outcomes (3)
Randomization to delivery interval
Rate of cesarean delivery for non reassuring fetal status
Rate of uterine hyperstimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startMay 2002
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor InductionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- 210 participants
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Investigators
- Daniel W Skupski, MD, Principal investigator, Weill Medical College of Cornell UniversityMichael Cabbad, MD, Principal investigator, The Brooklyn Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504465
- Sponsor's protocol ID
- 0402-264
- Status last verified
- Jul 2007
- First submitted
- 19 Jul 2007
- Last updated
- 20 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Ripening and Induction of Labor: a Randomized Controlled Trial of Combined Versus Sequential Use of Dinoprostone and Oxytocin.
- ClinicalTrials.gov ID
- NCT00504465
- Acronym / sponsor ID
- 0402-264
- Conditions
- Labor Induction, Cervical Ripening
- Keywords
- Labor, Labor induction, Cervical ripening, Dinoprostone, Fetal safety, Oxytocin, Cesarean delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- May 2002
- Study completion
- Apr 2007 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from smaller trials and add to data on fetal safety.
Detailed description
This study is a non-blinded, three arm randomized trial at 3 sites. Entry criteria were: >36 weeks' singleton, cephalic gestation with intact membranes and an unripe cervix (Bishop's score <6). Study arms were: 1) dinoprostone vaginal insert (Cervidil) for 12 hours followed by oxytocin, 2) dinoprostone vaginal insert (Cervidil) for 12 hours with simultaneous oxytocin, and 3) intracervical dinoprostone gel (Prepidil)(one dose) followed by immediate oxytocin. Primary outcome measure was the rate of vaginal delivery <24 hours. Secondary outcomes were randomization to delivery interval, rate of cesarean delivery (CD) for non reassuring fetal status (NRFS) and rate of uterine hyperstimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- > or = to 36 weeks of gestation
- Singleton fetus
- Cephalic presentation
- Intact membranes and an unripe cervix (Bishop score <6)
Key exclusion criteria (8 listed)
- Multifetal gestation
- Rupture of membranes
- Ripe cervix (Bishop score >6)
- Active labor
- Contraindication to vaginal delivery
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 |
|---|---|---|
| dinoprostone | Drug | – |
Primary outcome
Rate of vaginal delivery <24 hours
3 secondary outcomes
Randomization to delivery interval
Rate of cesarean delivery for non reassuring fetal status
Rate of uterine hyperstimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2007.
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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.
Daniel W Skupski, MD principal investigator
Weill Medical College of Cornell University
Michael Cabbad, MD principal investigator
The Brooklyn Hospital Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dinoprostone in people with Labor Induction and Cervical Ripening, run by Weill Medical College of Cornell University 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 4 inclusion and 8 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 Jul 2007. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of vaginal delivery <24 hours. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2007.