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

Management of Delivery Clinical Trial

— PLADRAINAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655576
• Other study ID #: PLADRAINAGE
• Secondary ID: Pla1
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: June 4, 2013
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2012
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Management of Delivery

Intervention

Procedure:
• Placental drainage
After delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta.

Locations

Country	Name	City	State
Brazil	IMIP	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the third period of labor	Time from delivery of the baby to the delivery of the placenta	Six hours	No
Secondary	Postpartum blood loss	Volume of blood lost 24 hours after birth	24 hours	No
Secondary	PPH	Postpartum hemorrhage	24 hours	No
Secondary	Need of uterotonics	use of aditional uterotonics ( prophylkatic use not included)	24 hours	No
Secondary	Need of blood transfusions	Need of blood transfusions	until discharge	No