The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes
The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes.
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The study aimed to examine the effect of prolonging the second stage of labor on the rate of Cesarean section (CS), maternal and neonatal outcomes.
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).
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Haifa, Israël
- Rambam Health Care Campus
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
1. Singleton deliveries at or beyond 37 weeks' gestation.
Exclusion Criteria:
- Non-vertex presentation.
- Trial of labor after CS.
- High risk pregnancy (multiple gestation, preeclampsia, diabetes mellitus, intrauterine growth restriction).
- Known fetal anomalies and intrauterine fetal demise.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Prolonged second stage of labor
Women with prolonged second stage of labor as specified before.
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To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The rate of primary CS.
Tijdsspanne: Between 2011 and 2017.
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The rate of primary CS in percentage of the total participants.
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Between 2011 and 2017.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The rate of operative vaginal delivery.
Tijdsspanne: Between 2011 and 2017.
|
The rate of operative vaginal delivery in percentage of the total participants.
|
Between 2011 and 2017.
|
|
Post-partum hemorrhage.
Tijdsspanne: Between 2011 and 2017.
|
Post-partum hemorrhage as estimated in liters.
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Between 2011 and 2017.
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The need for blood transfusion.
Tijdsspanne: Between 2011 and 2017.
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Number and type of blood products required post-partum and calculation of the number of patients that required blood products out of the total number of participants in percentage.
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Between 2011 and 2017.
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Third-and fourth-degree laceration rate.
Tijdsspanne: Between 2011 and 2017.
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Third-and fourth-degree laceration rate of the total number of participants.
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Between 2011 and 2017.
|
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Chorioamnionitis rate.
Tijdsspanne: Between 2011 and 2017.
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Chorioamnionitis rate in percentage of the total participants.
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Between 2011 and 2017.
|
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Admission to the NICU.
Tijdsspanne: Between 2011 and 2017.
|
Admission to the NICU in percentage of the total participants.
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Between 2011 and 2017.
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Kamel Mattar, MD, Principal Investigator
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 0258-17-RMB
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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