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
  Purpose

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


Condition Intervention
Management of Delivery
Procedure: Placental drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Placental Drainage in the Third Stage of Labor: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 226
Study Start Date: August 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655576

Locations
Brazil
IMIP
Recife, Pernambuco, Brazil, 50.000
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
  More Information

No publications provided

Responsible Party: Leila Katz, MD pHD, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT01655576     History of Changes
Other Study ID Numbers: PLADRAINAGE, Pla1
Study First Received: July 31, 2012
Last Updated: June 4, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
drainage
pregnancy
active management
postpartum hemorrhage

ClinicalTrials.gov processed this record on April 17, 2014