Effectiveness of Placental Drainage in the Third Stage of Labor: a Randomized Clinical Trial (PLADRAINAGE)

June 4, 2013 updated by: Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
The purpose of this study is to determine if placental drainage shortens third period of labor and reduces postpartum blood lost.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study aims to compare the effectiveness of placental drainage versus maintenance of maternal cord clamped end in the third stage of labor to reduce postpartum blood loss.

Study Type

Interventional

Enrollment (Actual)

226

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

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50.000
        • IMIP

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Low risk pregnant women
  • Pregnancy at term
  • Women at low risk for assisted labor / delivery and postpartum care.
  • Live Fetus

Exclusion Criteria:

  • Women under 18, mentally handicapped and indigenous;
  • Women who agreed to participate signed the Informed Consent, but evolved to cesarean section or instrumental delivery by forceps;
  • Instrumental Delivery by forceps or c-section

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
No Intervention: Routine clamping
After delivery of the newborn, umbilical cord at mothers end, will be left clamped until delivery of the placenta.
Experimental: Placental drainage
After delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta.
Procedure: Placental drainage
After delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the third period of labor
Time Frame: Six hours
Time from delivery of the baby to the delivery of the placenta
Six hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum blood loss
Time Frame: 24 hours
Volume of blood lost 24 hours after birth
24 hours
PPH
Time Frame: 24 hours
Postpartum hemorrhage
24 hours
Need of uterotonics
Time Frame: 24 hours
use of aditional uterotonics ( prophylkatic use not included)
24 hours
Need of blood transfusions
Time Frame: until discharge
Need of blood transfusions
until discharge

Collaborators and Investigators

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

Sponsor

Instituto Materno Infantil Prof. Fernando Figueira

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

August 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

August 1, 2012

First Posted (Estimate)

August 2, 2012

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PLADRAINAGE
  • Pla1 (Registry Identifier: Placenta1)

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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