Placental Cord Drainage Versus no Placental Drainage in the Management of Third Stage of Labour
PLCD
1 other identifier
interventional
180
1 country
1
Brief Summary
The aim of this work is to compare the effectiveness of placental cord drainage with no drainage in reducing the duration and blood loss in 3rd stage of labour.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
1 active site
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
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
May 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedAugust 16, 2017
August 1, 2017
10 months
April 4, 2017
August 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of the third stage of labour
within 15 min of delivery of baby
Secondary Outcomes (5)
Amount of blood loss
FIRST 24 HOURS
retained placenta
1ST HOUR OF DELIVERY
Manual removal of placenta
1HOUR OF DELIVERY
Changes in maternal haematocrit (Hct) after birth
1ST 24 HOURS
blood transfusion
1ST 24 HOURS
Study Arms (2)
placental cord drainage
EXPERIMENTALIn 90 women after vaginal delivery of the baby, the placental end of the cut umbilical cord 1st will be clamped for few seconds and then unclamped and left open to drain blood in a vessel until flow stoped. This will prevent the drained blood from getting mixed with blood lost in the 3rd stage.
Non placental cord drainage
ACTIVE COMPARATORIn 90 women after vaginal delivery of the baby placental end of the cut umbilical cord will be kept clamped.
Interventions
In the study group a of total number of 90 women placental end of the cut umbilical cord 1st will be clamped for few seconds and then unclamped and left open to drain blood in a vessel until flow stoped. This will prevent the drained blood from getting mixed with blood lost in the 3rd stage. Blood loss in the third stage will be measured using a Kelly's pad which will be used during delivery and the blood lost will be collected in a clean metal bowl which will be kept at the tail end of Kelley's pad.
In 90 women after vaginal delivery of the baby placental end of the cut umbilical cord will be kept clamped.
Eligibility Criteria
You may qualify if:
- Full term Uncomplicated singleton pregnancy Pregnancy with vertex presentation Patients expected to have spontaneous vaginal delivery
You may not qualify if:
- Over distended uterus(hydramnios.large fetus) Previous history of postpartum haemorrhage Known coagulation disorder Haemoglobin less than 8 g/dl Ante partum haemorrhage Multiple pregnancies Instrumental delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain shams university maternity hospital
Cairo, 25187, Egypt
Study Officials
- STUDY CHAIR
Hassan A Bayoumy, MD
Ain Shams University
- STUDY DIRECTOR
Amgad E Abou-Gamrah, MD
Ain Shams University
Central Study Contacts
Hassan A Bayoumy, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal invesigator
Study Record Dates
First Submitted
April 4, 2017
First Posted
May 3, 2017
Study Start
January 1, 2017
Primary Completion
November 1, 2017
Study Completion
November 30, 2017
Last Updated
August 16, 2017
Record last verified: 2017-08