Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery

January 11, 2017 updated by: Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in decreasing the duration, blood loss,and complications of the third stage, against no drainage of placental blood.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The patients will prospectively randomized equally into two groups (100 each in the study and control groups).

Group-A (Study group)-Placental blood was drained.

Group-B (Control group)-Placental blood was not drained.

In all the patients detailed medical and obstetric history will taken. In each patient, the pre-delivery pulse rate, blood pressure, and Hb gm% will noted. Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased. In the control group, the clamped cord will not released. Blood lost in the third stage of labour will measured by collecting the blood measuring bag.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

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

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton pregnancy
  • Vertex presentation
  • Gestational age of 37 weeks (or) more
  • No major medical (or) obstetric complications
  • Spontaneous vaginal delivery

Exclusion Criteria:

  • Hb\7 gm/dl
  • History of APH
  • Instrumental delivery
  • Multiple pregnancy
  • Malpresentations
  • Large baby (more than 3.5 kg)
  • Polyhydramnios
  • Known coagulations disorders
  • Previous surgeries on the uterus

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placental Blood Drainage
Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.
Procedure: Placental Blood Drainage
Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.
Active Comparator: not Placental Blood Drainage
In the control group, the clamped cord will not released.
Procedure: not Placental Blood Drainage
In the control group, the clamped cord will not released.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood lost
Time Frame: through delivery completion, an average of 30 minutes
through delivery completion, an average of 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The duration of the third stage
Time Frame: through the duration of the third stage, an average 45 minutes
The duration of the third stage will calculated using a stop watch.
through the duration of the third stage, an average 45 minutes

Collaborators and Investigators

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

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2017

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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.

Clinical Trials on Placental Blood Drainage

Clinical Trials on Placental Blood Drainage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe