Medical Induction of Labor Affecting NewbornNCT02825641
Premature Rupture of Membranes With a Bishop Score<6: Comparison of Medical Induction/Expectant Management
A study testing Oxytocin and Dinoprostone in people with Medical Induction of Labor Affecting Newborn, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The study is intended to compare expectant management and on presentation labor induction in women with premature rupture of membranes. The means of labor induction and cervical ripening are either oxytocin or dinoprostone. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Medical Induction of Labor Affecting Newborn
- What is being tested?
- Oxytocin and Dinoprostone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2016to 30 Sep 2022
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Term pregnancies >37 weeks of gestation.
- Certain rupture of membranes.
- Bishop score < 6.
- Singleton pregnancies.
- Vertex presentation.
- No obstetric or clinical contraindications for labor induction.
- Reactive non stress test on presentation.
Who cannot join
- Previous cesarean section.
- Previous uterine surgeries (Myomectomy etc.).
- Placenta Previa.
- Multiple gestation pregnancies.
- Pregnancies with history of fetal reduction or Intrapartum uterine fetal demise.
- Known fetal defects/Chromosomal abnormalities.
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- Active genital Herpes.
- HIV carrier.
- Contractions that are less than 10 minutes apart.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Premature Rupture of Membranes at Term With an Unfavorable Cervix (Bishop Score<6): Comparison of Oxytocin, Dinoprostone Induction and Expectant Management
The study is intended to compare expectant management and on presentation labor induction in women with premature rupture of membranes.
The means of labor induction and cervical ripening are either oxytocin or dinoprostone.
Read more
Expectant management in this obstetrical state means waiting 24 hours from the onset of rupture of membranes and then commencing labor induction with either oxytocin or dinoprostone depending on the patient's obstetrical history and cervical condition.
The investigators' hypothesis is that active management will lead to a higher rate of vaginal deliveries, a shorter interval between the time of rupture of membranes and the time of delivery, a lower rate of cesarean sections and a better obstetric result for the mother and the fetus/newborn.
Read the detailed description
In the setting of premature rupture of membranes in term pregnancies, it is customary in women who are not in active labor to wait for 24 hours before attempting to induce labor. The means of labor induction used at our medical center are either intravenous oxytocin or per-vaginal dinoprostone, depending on patient's obstetric history and cervical conditions.
The investigators hypothesize that commencing induction of labor at presentation in these women by either means of induction will lead to higher rates of vaginal delivery, shorter intervals between the time of onset of rupture of membranes and the time of delivery and lower rates of cesarean sections.
The participants in the study, upon signing informed consents, will be randomized to 4 groups-2 groups of expectant management in which labor induction will be commenced after 24 hours with either oxytocin or dinoprostone and 2 groups of active management in which labor induction will be commenced at presentation with either oxytocin or dinoprostone.
The participants will be followed from the time of presentation with rupture of membranes at the delivery room and until the time of delivery.
Further obstetric, clinical and demographic information will be acquired from the patient's electronic medical file for analysis accuracy and sub-analysis.
- Being tested
- Oxytocin, Dinoprostone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Pitocin
Labor induction and cervical ripening by oxytocin in women with premature rupture of membranes in 2 types of women:
- Induction of labor on presentation at the delivery room.
- Induction of labor after 24 hours of rupture of membranes.
DinoprostoneDrug
Also called Cervidil
Labor induction and cervical ripening by dinoprostone in women with premature rupture of membranes in 2 types of women:
- Induction of labor on presentation at the delivery room.
- Induction of labor after 24 hours of rupture of membranes.
| Study group | Role | What they receive |
|---|---|---|
| Expectant Management-Dinoprostone | Active comparator | Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6).
Labor induction will be initiated with Dinoprostone after 24 hours of waiting depending on obstetric history and cervical conditions. Receives: Drug: Dinoprostone |
| Expectant Management-Oxytocin | Active comparator | Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6).
Labor induction will be initiated with oxytocin after 24 hours of waiting depending on obstetric history and cervical conditions. Receives: Drug: Oxytocin |
| Active Management-Dinoprostone | Experimental | Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6).
Labor induction will be initiated with Dinoprostone on presentation depending on obstetric history and cervical conditions. Receives: Drug: Dinoprostone |
| Active Management-Oxytocin | Experimental | Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6).
Labor induction will be initiated with oxytocin on presentation depending on obstetric history and cervical conditions. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal delivery rate
The percentage of participants that achieved vaginal delivery
Measured: Up to 7 days from the time of presentation with rupture of membranes
Secondary outcomes (2)
Interval to delivery
Interval from the time of onset of premature rupture of membranes and the time of delivery (In minutes)
Measured: Up to 7 days from the time of presentation with rupture of membranes
Caesarian delivery rate
The percentage of participants that required caesarian delivery
Measured: Up to 7 days from the time of presentation with rupture of membranes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start1 Aug 2016
- Primary completion1 Nov 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Induction of Labor Affecting NewbornStudies 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
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Amir Weissman, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825641
- Sponsor's protocol ID
- 0213-15-RMB
- Status last verified
- Oct 2022
- First submitted
- 6 Jun 2016
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premature Rupture of Membranes at Term With an Unfavorable Cervix (Bishop Score<6): Comparison of Oxytocin, Dinoprostone Induction and Expectant Management
- ClinicalTrials.gov ID
- NCT02825641
- Acronym / sponsor ID
- 0213-15-RMB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 7 Jul 2016 (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.
The study is intended to compare expectant management and on presentation labor induction in women with premature rupture of membranes.
The means of labor induction and cervical ripening are either oxytocin or dinoprostone.
Expectant management in this obstetrical state means waiting 24 hours from the onset of rupture of membranes and then commencing labor induction with either oxytocin or dinoprostone depending on the patient's obstetrical history and cervical condition.
The investigators' hypothesis is that active management will lead to a higher rate of vaginal deliveries, a shorter interval between the time of rupture of membranes and the time of delivery, a lower rate of cesarean sections and a better obstetric result for the mother and the fetus/newborn.
Detailed description
In the setting of premature rupture of membranes in term pregnancies, it is customary in women who are not in active labor to wait for 24 hours before attempting to induce labor. The means of labor induction used at our medical center are either intravenous oxytocin or per-vaginal dinoprostone, depending on patient's obstetric history and cervical conditions.
The investigators hypothesize that commencing induction of labor at presentation in these women by either means of induction will lead to higher rates of vaginal delivery, shorter intervals between the time of onset of rupture of membranes and the time of delivery and lower rates of cesarean sections.
The participants in the study, upon signing informed consents, will be randomized to 4 groups-2 groups of expectant management in which labor induction will be commenced after 24 hours with either oxytocin or dinoprostone and 2 groups of active management in which labor induction will be commenced at presentation with either oxytocin or dinoprostone.
The participants will be followed from the time of presentation with rupture of membranes at the delivery room and until the time of delivery.
Further obstetric, clinical and demographic information will be acquired from the patient's electronic medical file for analysis accuracy and sub-analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Expectant Management-Dinoprostone | Active comparator | Drug: DinoprostoneWomen with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6). Labor induction will be initiated with Dinoprostone after 24 hours of waiting depending on obstetric history and cervical conditions. |
| Expectant Management-Oxytocin | Active comparator | Drug: OxytocinWomen with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6). Labor induction will be initiated with oxytocin after 24 hours of waiting depending on obstetric history and cervical conditions. |
| Active Management-Dinoprostone | Experimental | Drug: DinoprostoneWomen with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6). Labor induction will be initiated with Dinoprostone on presentation depending on obstetric history and cervical conditions. |
| Active Management-Oxytocin | Experimental | Drug: OxytocinWomen with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6). Labor induction will be initiated with oxytocin on presentation depending on obstetric history and cervical conditions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Term pregnancies >37 weeks of gestation.
- Certain rupture of membranes.
- Bishop score < 6.
- Singleton pregnancies.
- Vertex presentation.
Key exclusion criteria (9 listed)
- Previous cesarean section.
- Previous uterine surgeries (Myomectomy etc.).
- Placenta Previa.
- Multiple gestation pregnancies.
- Pregnancies with history of fetal reduction or Intrapartum uterine fetal demise.
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 |
|---|---|---|
| OxytocinAlso: PitocinLabor induction and cervical ripening by oxytocin in women with premature rupture of membranes in 2 types of women: 1. Induction of labor on presentation at the delivery room. 2. Induction of labor after 24 hours of rupture of membranes. | Drug | Active Management-Oxytocin, Expectant Management-Oxytocin |
| DinoprostoneAlso: CervidilLabor induction and cervical ripening by dinoprostone in women with premature rupture of membranes in 2 types of women: 1. Induction of labor on presentation at the delivery room. 2. Induction of labor after 24 hours of rupture of membranes. | Drug | Active Management-Dinoprostone, Expectant Management-Dinoprostone |
Primary outcome
Vaginal delivery rate
Time frame: Up to 7 days from the time of presentation with rupture of membranes
The percentage of participants that achieved vaginal delivery
2 secondary outcomes
Interval to delivery
Time frame: Up to 7 days from the time of presentation with rupture of membranes
Caesarian delivery rate
Time frame: Up to 7 days from the time of presentation with rupture of membranes
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 26 Oct 2022.
- Individual participant dataSharing planned: No
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.
Amir Weissman, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin and Dinoprostone in people with Medical Induction of Labor Affecting Newborn, run by Rambam Health Care Campus at 1 site in Israel.
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 7 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: finished, as of the sponsor's last update on 26 Oct 2022. 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 Israel. 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?
Vaginal delivery rate (time frame: Up to 7 days from the time of presentation with rupture of membranes). 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 26 Oct 2022.