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

This study is not yet open for participant recruitment.
Verified July 2012 by Instituto Materno Infantil Prof. Fernando Figueira
Sponsor:
Information provided by (Responsible Party):
Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT01655576
First received: July 31, 2012
Last updated: August 1, 2012
Last verified: July 2012
History of Changes

July 31, 2012
August 1, 2012
August 2012
February 2013   (final data collection date for primary outcome measure)
Duration of the third period of labor [ Time Frame: Six hours ] [ Designated as safety issue: No ]
Time from delivery of the baby to the delivery of the placenta
Same as current
Complete list of historical versions of study NCT01655576 on ClinicalTrials.gov Archive Site
Postpartum blood loss [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Volume of blood lost 24 hours after birth, postpartum hemorrhage, difference in hemoglobin (before and 24 hours after delivery), need of uterotonics, intervention and blood transfusion.
Same as current
Not Provided
Not Provided
 
Effectiveness of Placental Drainage in the Third Stage of Labor: a Randomized Clinical Trial
Effectiveness of Placental Drainage in the Third Stage of Labor: a Randomized Clinical Trial

The purpose of this study is to determine if placental drainage shortens third period of labor and reduces postpartum blood lost.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Management of Delivery
Procedure: Placental drainage
After delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta.
  • 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.
    Intervention: Procedure: Placental drainage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
226
March 2013
February 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Leila Katz, MD PhD 55 81 21224739 ext 4739 katzleila@gmail.com
Contact: Melania M Amorim, MD PhD 55 81 21224739 ext 4739 melania.amorim@gmail.com
Brazil
 
NCT01655576
PLADRAINAGE, Pla1
Yes
Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
Instituto Materno Infantil Prof. Fernando Figueira
Not Provided
Not Provided
Instituto Materno Infantil Prof. Fernando Figueira
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP