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The Effect of Primary Cesarean Section Prevention on Maternal and Neonatal Outcomes

17. august 2018 opdateret af: Kamel Mattar MD, Rambam Health Care Campus

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

20000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Pregnant women in labor

Beskrivelse

Inclusion Criteria:

1. Singleton deliveries at or beyond 37 weeks' gestation.

Exclusion Criteria:

  1. Non-vertex presentation.
  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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Prolonged second stage of labor
Women with prolonged second stage of labor as specified before.
Andet: Protocol change
To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The rate of primary CS.
Tidsramme: Between 2011 and 2017.
The rate of primary CS in percentage of the total participants.
Between 2011 and 2017.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The rate of operative vaginal delivery.
Tidsramme: Between 2011 and 2017.
The rate of operative vaginal delivery in percentage of the total participants.
Between 2011 and 2017.
Post-partum hemorrhage.
Tidsramme: Between 2011 and 2017.
Post-partum hemorrhage as estimated in liters.
Between 2011 and 2017.
The need for blood transfusion.
Tidsramme: Between 2011 and 2017.
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.
Between 2011 and 2017.
Third-and fourth-degree laceration rate.
Tidsramme: Between 2011 and 2017.
Third-and fourth-degree laceration rate of the total number of participants.
Between 2011 and 2017.
Chorioamnionitis rate.
Tidsramme: Between 2011 and 2017.
Chorioamnionitis rate in percentage of the total participants.
Between 2011 and 2017.
Admission to the NICU.
Tidsramme: Between 2011 and 2017.
Admission to the NICU in percentage of the total participants.
Between 2011 and 2017.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Rambam Health Care Campus

Efterforskere

  • Ledende efterforsker: Kamel Mattar, MD, Principal Investigator

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2017

Primær færdiggørelse (Faktiske)

1. marts 2018

Studieafslutning (Faktiske)

1. maj 2018

Datoer for studieregistrering

Først indsendt

14. august 2018

Først indsendt, der opfyldte QC-kriterier

17. august 2018

Først opslået (Faktiske)

21. august 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 0258-17-RMB

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Komplikationer ved kejsersnit

Kliniske forsøg med Protocol change

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Belgium

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner