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Effect of Uterine Artery Ligation Prior to Uterine Incision in Women With Placenta Previa

30. januar 2018 oppdatert av: Ahmed Maged, Cairo University

Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.

  • The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
  • Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged.
  • Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.
  • Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
  • Closure of the anterior abdominal wall in layers

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.

  • The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
  • Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged.
  • Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.
  • Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
  • Closure of the anterior abdominal wall in layers In the control group, lower segment caesarean section is without uterine artery ligation

Studietype

Intervensjonell

Registrering (Forventet)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Egypt
      • Cairo, Egypt, 12151
        • Rekruttering
        • Kasr Alainy medical school

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

19 år til 40 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • patients diagnosed with placenta praevia antenatally
  • plan is elective caesarean section
  • Gestational age >34 weeks

Exclusion Criteria:

  • Fetal distress
  • medical disorders as hypertension or Diabetes Mellitus
  • Coagulation defects.
  • Emergency Cesarean section
  • women with antepartum hemorrhage
  • patients with marked ahdesions or those with non possible uterine artery ligation

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: uterine artery ligation

Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.

  • The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
  • Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged.
  • Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta.
Fremgangsmåte: uterine artery ligation
Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged
Fremgangsmåte: Lower segment Cesarean section

Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.

- The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.

Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.

  • Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
  • Closure of the anterior abdominal wall in layers
Aktiv komparator: Traditional lower segment Cesarean section

Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.

  • The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
  • Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta.
Fremgangsmåte: Lower segment Cesarean section

Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.

- The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.

Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.

  • Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
  • Closure of the anterior abdominal wall in layers

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Decrease in Hemoglabin level
Tidsramme: 24 hours after Cesarean
24 hours after Cesarean

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cairo University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2017

Primær fullføring (Forventet)

1. mai 2018

Studiet fullført (Forventet)

1. juni 2018

Datoer for studieregistrering

Først innsendt

19. april 2017

Først innsendt som oppfylte QC-kriteriene

19. april 2017

Først lagt ut (Faktiske)

21. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. januar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. januar 2018

Sist bekreftet

1. januar 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 169

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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