Back to resultsPlacental Cord Drainage After Vaginal Delivery
Primary Purpose
Blood Loss
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cord drainage
Cord clamping
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss
Eligibility Criteria
Inclusion Criteria:
- Singleton pregnancy.
- Pregnancy with vertex presentation.
- Gestational age37 up to 42 weeks
- Patient expected to have spontaneous vaginal delivery.
- Maternal age 18 years old or more.
Exclusion Criteria:
- Previous history of Postpartum hemorrhage.
- Antepartum hemorrhage
- Multiple pregnancies
- Instrumental deliveries
- Coagulation disorders
- Over distended uterus (hydramnios, large fetus).
- Patient with extensive extended vaginal or cervical tear.
- Rupture uterus.
- Secondary arrest of cervical dilatation.
- Persistent occipito-posterior.
- Deep transverse arrest of fetal head.
Sites / Locations
- Ain Shams University Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cord drainage
Cord clamping
Arm Description
Outcomes
Primary Outcome Measures
blood loss
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03487341
Brief Title
Placental Cord Drainage After Vaginal Delivery
Official Title
Placental Cord Drainage After Vaginal Delivery: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
November 10, 2018 (Actual)
Study Completion Date
November 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Placental Cord Drainage after Vaginal Delivery A randomized clinical trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cord drainage
Arm Type
Active Comparator
Arm Title
Cord clamping
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Cord drainage
Intervention Description
Cord drainage
Intervention Type
Other
Intervention Name(s)
Cord clamping
Intervention Description
Cord clamping
Primary Outcome Measure Information:
Title
blood loss
Time Frame
1 hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Singleton pregnancy.
Pregnancy with vertex presentation.
Gestational age37 up to 42 weeks
Patient expected to have spontaneous vaginal delivery.
Maternal age 18 years old or more.
Exclusion Criteria:
Previous history of Postpartum hemorrhage.
Antepartum hemorrhage
Multiple pregnancies
Instrumental deliveries
Coagulation disorders
Over distended uterus (hydramnios, large fetus).
Patient with extensive extended vaginal or cervical tear.
Rupture uterus.
Secondary arrest of cervical dilatation.
Persistent occipito-posterior.
Deep transverse arrest of fetal head.
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Placental Cord Drainage After Vaginal Delivery
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