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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Haifa, Israel
- Rambam Health Care Campus
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The rate of primary CS.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The rate of operative vaginal delivery.
Tidsramme: Between 2011 and 2017.
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The rate of operative vaginal delivery in percentage of the total participants.
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Between 2011 and 2017.
|
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Post-partum hemorrhage.
Tidsramme: Between 2011 and 2017.
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Post-partum hemorrhage as estimated in liters.
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Between 2011 and 2017.
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The need for blood transfusion.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: Between 2011 and 2017.
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Admission to the NICU in percentage of the total participants.
|
Between 2011 and 2017.
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Kamel Mattar, MD, Principal Investigator
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 0258-17-RMB
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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