Placental Cord Drainage After Vaginal Delivery | NCT03487341

Studies
Placental Cord Drainage After Vaginal Delivery

NCT03487341

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jan 29, 2019Actual

Enrollment

600Actual

Phase

Not Applicable

Conditions

Blood Loss

Interventions

Cord drainage
Cord clamping

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Actual

Primary Completion Date

Nov 10, 2018Actual

Completion Date

Nov 10, 2018Actual

First Submitted Date

Mar 24, 2018

First Submission Date that Met QC Criteria

Apr 2, 2018

First Posted Date

Apr 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2019

Last Update Posted Date

Jan 29, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cord drainage	Active Comparator		Other: Cord drainage
Cord clamping	Active Comparator		Other: Cord clamping

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cord drainage	Other	Cord drainage	Cord drainage
Cord clamping

Measure	Description	Time Frame
blood loss		1 hour

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University Maternity Hospital		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000087526	Umbilical Cord Clamping

Ancestor Terms

ID	Term
D036861	Delivery, Obstetric
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided