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

This study has been completed.
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: June 4, 2013
Last verified: July 2012

July 31, 2012
June 4, 2013
August 2012
May 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
  • PPH [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Postpartum hemorrhage
  • Need of uterotonics [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    use of aditional uterotonics ( prophylkatic use not included)
  • Need of blood transfusions [ Time Frame: until discharge ] [ Designated as safety issue: No ]
    Need of blood transfusions
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.
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.
 
Completed
226
May 2013
May 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 information is only displayed when the study is recruiting subjects
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