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

30 januari 2018 uppdaterad 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

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Förväntat)

200

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Egypten
      • Cairo, Egypten, 12151
        • Rekrytering
        • Kasr Alainy Medical School

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

19 år till 40 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / 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.
Procedur: 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
Procedur: 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.
Procedur: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Decrease in Hemoglabin level
Tidsram: 24 hours after Cesarean
24 hours after Cesarean

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Cairo University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2017

Primärt slutförande (Förväntat)

1 maj 2018

Avslutad studie (Förväntat)

1 juni 2018

Studieregistreringsdatum

Först inskickad

19 april 2017

Först inskickad som uppfyllde QC-kriterierna

19 april 2017

Första postat (Faktisk)

21 april 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

31 januari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 januari 2018

Senast verifierad

1 januari 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 169

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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