Omission of Controlled Cord Traction During Active Management of Third Stage of Labor

Overview

This is a comparative study which will be conducted in Ain Shams University Maternity hospital to assess the individual and specfic role of controlled cord traction as a part of active management of third stage of labor

Full Title of Study: “Omission of Controlled Cord Traction During Active Management of Third Stage of Labor. A Single Blinded Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 2018

Detailed Description

300 patients will be randomized into two groups with controlled cord traction and withoout. The primary outcome will be sever postpartum haemorrhage

Interventions

  • Procedure: Ommited controlled cord traction
    • No controlled cord traction and no fundal pressure. placenta will be allowed to deliver physiologically
  • Procedure: controlled cord traction
    • active management of third stage of labor in the form of uterine massage with controlled cord traction

Arms, Groups and Cohorts

  • Experimental: omiited controlled cord traction
    • neither controlled cord traction nor fundal pressure will be applied. The placenta will be delivered physiologically and signs of placental separation will be awaited
  • Active Comparator: controlled cord traction
    • the cord will be held in one hand and the other hand will be placed just above the woman’s pubic boneto stabilize the uterus during cord traction

Clinical Trial Outcome Measures

Primary Measures

  • sever post partum haemorrhage
    • Time Frame: 24 hours
    • blood loss more than 500 cc

Secondary Measures

  • duration of third stage of labor
    • Time Frame: 30 minutes
    • from delivery of the baby to delivery of the placenta

Participating in This Clinical Trial

Inclusion Criteria

  • singleton pregnancy – term pregnancy Exclusion Criteria:

  • episiotomy – operative vaginal delivery – known coagulation defect – Acute complication during labor e.g. eclampsia

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed Mohamed El Kotb Abdel Fattah, dr. Ahmed Kotb – Ain Shams University
  • Overall Official(s)
    • Ahmed M kotb, MD, Principal Investigator, Ain Shams University
  • Overall Contact(s)
    • ahmed M Kotb, MD, 010086819990, ahmedmkotp@hotmail.com

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