The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes
NCT ID: NCT03640702
Last Updated: 2018-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20000 participants
OBSERVATIONAL
2017-08-01
2018-05-01
Brief Summary
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The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.
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Detailed Description
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The study compared 2 time periods. The first time period was between May 2011 until April 2014 when a prolonged second stage in nulliparous women was considered three hours with regional anesthesia or two hours if no such anesthesia was provided. Second stage arrest was defined in multiparous women after two hours with regional anesthesia or one hour without it. The second time period was between May 2014 until April 2017, allowed nulliparous and multiparous women to continue the second stage of labor an additional one hour before diagnosing second-stage arrest. Singleton deliveries at or beyond 37 weeks' gestation were initially considered for eligibility.
The rate of CS, operative vaginal deliveries, 3rd and 4th degree lacerations, postpartum hemorrhage, arterial cord PH below 7 and admissions to the neonatal intensive care unit (NICU).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Prolonged second stage of labor
Women with prolonged second stage of labor as specified before.
Protocol change
To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes
Interventions
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Protocol change
To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Trial of labor after CS.
3. High risk pregnancy (multiple gestation, preeclampsia, diabetes mellitus, intrauterine growth restriction).
4. Known fetal anomalies and intrauterine fetal demise.
FEMALE
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Kamel Mattar MD
Principal Investigator
Principal Investigators
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Kamel Mattar, MD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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Rambam Health Care Campus
Haifa, , Israel
Countries
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Other Identifiers
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0258-17-RMB
Identifier Type: -
Identifier Source: org_study_id
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