Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in decreasing the duration, blood loss,and complications of the third stage, against no drainage of placental blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2016
CompletedFirst Posted
Study publicly available on registry
January 13, 2017
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJanuary 13, 2017
January 1, 2017
3 months
December 22, 2016
January 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Blood lost
through delivery completion, an average of 30 minutes
Secondary Outcomes (1)
The duration of the third stage
through the duration of the third stage, an average 45 minutes
Study Arms (2)
Placental Blood Drainage
EXPERIMENTALImmediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.
not Placental Blood Drainage
ACTIVE COMPARATORIn the control group, the clamped cord will not released.
Interventions
Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.
In the control group, the clamped cord will not released.
Eligibility Criteria
You may qualify if:
- Singleton pregnancy
- Vertex presentation
- Gestational age of 37 weeks (or) more
- No major medical (or) obstetric complications
- Spontaneous vaginal delivery
You may not qualify if:
- Hb\\7 gm/dl
- History of APH
- Instrumental delivery
- Multiple pregnancy
- Malpresentations
- Large baby (more than 3.5 kg)
- Polyhydramnios
- Known coagulations disorders
- Previous surgeries on the uterus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Roy P, Sujatha MS, Bhandiwad A, Biswas B, Chatterjee A. Placental Blood Drainage as a Part of Active Management of Third Stage of Labour After Spontaneous Vaginal Delivery. J Obstet Gynaecol India. 2016 Oct;66(Suppl 1):242-5. doi: 10.1007/s13224-016-0857-3. Epub 2016 Mar 12.
PMID: 27651611RESULTSoltani H, Poulose TA, Hutchon DR. Placental cord drainage after vaginal delivery as part of the management of the third stage of labour. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD004665. doi: 10.1002/14651858.CD004665.pub3.
PMID: 21901693RESULT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
December 22, 2016
First Posted
January 13, 2017
Study Start
February 1, 2017
Primary Completion
May 1, 2017
Study Completion
June 1, 2017
Last Updated
January 13, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will share