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

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ClinicalTrials.gov Identifier: NCT02656108
Recruitment Status : Recruiting
First Posted : January 14, 2016
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Labor Stage, Third Procedure: Ommited controlled cord traction Procedure: controlled cord traction Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Omission of Controlled Cord Traction During Active Management of Third Stage of Labor. A Single Blinded Randomized Controlled Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Arm Intervention/treatment
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
Procedure: Ommited controlled cord traction
No controlled cord traction and no fundal pressure. placenta will be allowed to deliver physiologically

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
Procedure: controlled cord traction
active management of third stage of labor in the form of uterine massage with controlled cord traction




Primary Outcome Measures :
  1. sever post partum haemorrhage [ Time Frame: 24 hours ]
    blood loss more than 500 cc


Secondary Outcome Measures :
  1. duration of third stage of labor [ Time Frame: 30 minutes ]
    from delivery of the baby to delivery of the placenta



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • singleton pregnancy
  • term pregnancy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656108


Contacts
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Contact: ahmed M Kotb, MD 010086819990 ext 0020 ahmedmkotp@hotmail.com
Contact: ahmed M kotb, MD 1008681999 ext 0020 ahmedmkotp@hotmail.com

Locations
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Egypt
Faculty of Medicine, Ain Shams University Recruiting
Cairo, Al Qahirah, Egypt
Contact: ahmed kotb, MD    2001008681999    ahmedmkotp@hotmail.com   
Contact: ahmed kotb       ahmedmkotp@hotmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Ahmed M kotb, MD Ain Shams University

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Responsible Party: Ahmed Mohamed El Kotb Abdel Fattah, dr. Ahmed Kotb, Ain Shams University
ClinicalTrials.gov Identifier: NCT02656108     History of Changes
Other Study ID Numbers: CCO
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No