Placental Cord Drainage Versus no Placental Drainage in the Management of Third Stage of Labour (PLCD)

August 13, 2017 updated by: Ahmed Abdel Shafy El Shahawy, Ain Shams University

Placental Cord Drainage Versus no Placental Drainage in the Management of Third Stage of Labour: Randomized Controlled Trial

The aim of this work is to compare the effectiveness of placental cord drainage with no drainage in reducing the duration and blood loss in 3rd stage of labour.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 25187
        • Recruiting
        • Ain Shams University Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Full term Uncomplicated singleton pregnancy Pregnancy with vertex presentation Patients expected to have spontaneous vaginal delivery

Exclusion Criteria:

  • Over distended uterus(hydramnios.large fetus) Previous history of postpartum haemorrhage Known coagulation disorder Haemoglobin less than 8 g/dl Ante partum haemorrhage Multiple pregnancies Instrumental delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: placental cord drainage
In 90 women after vaginal delivery of the baby, the placental end of the cut umbilical cord 1st will be clamped for few seconds and then unclamped and left open to drain blood in a vessel until flow stoped. This will prevent the drained blood from getting mixed with blood lost in the 3rd stage.
Procedure: placental cord drainage

In the study group a of total number of 90 women placental end of the cut umbilical cord 1st will be clamped for few seconds and then unclamped and left open to drain blood in a vessel until flow stoped. This will prevent the drained blood from getting mixed with blood lost in the 3rd stage.

Blood loss in the third stage will be measured using a Kelly's pad which will be used during delivery and the blood lost will be collected in a clean metal bowl which will be kept at the tail end of Kelley's pad.
Active Comparator: Non placental cord drainage
In 90 women after vaginal delivery of the baby placental end of the cut umbilical cord will be kept clamped.
Procedure: non placemtal cord drainage
In 90 women after vaginal delivery of the baby placental end of the cut umbilical cord will be kept clamped.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of the third stage of labour
Time Frame: within 15 min of delivery of baby
within 15 min of delivery of baby

Secondary Outcome Measures

Outcome Measure
Time Frame
Amount of blood loss
Time Frame: FIRST 24 HOURS
FIRST 24 HOURS
retained placenta
Time Frame: 1ST HOUR OF DELIVERY
1ST HOUR OF DELIVERY
Manual removal of placenta
Time Frame: 1HOUR OF DELIVERY
1HOUR OF DELIVERY
Changes in maternal haematocrit (Hct) after birth
Time Frame: 1ST 24 HOURS
1ST 24 HOURS
blood transfusion
Time Frame: 1ST 24 HOURS
1ST 24 HOURS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Hassan A Bayoumy, MD, Ain Shams University
  • Study Director: Amgad E Abou-Gamrah, MD, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 30, 2017

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 30, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 13, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Placental Cord Drainage versus

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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