NCT03487341

Brief Summary

Placental Cord Drainage after Vaginal Delivery A randomized clinical trial

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2018

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

March 24, 2018

Last Update Submit

January 26, 2019

Conditions

Blood Loss

Outcome Measures

Primary Outcomes (1)

  • blood loss

    1 hour

Study Arms (2)

Cord drainage

ACTIVE COMPARATOR
Other: Cord drainage

Cord clamping

ACTIVE COMPARATOR
Other: Cord clamping

Interventions

Cord drainageOTHER

Cord drainage

Cord drainage
Cord clampingOTHER

Cord clamping

Cord clamping

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

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 Investigator

Study Record Dates

First Submitted

March 24, 2018

First Posted

April 4, 2018

Study Start

April 1, 2018

Primary Completion

November 10, 2018

Study Completion

November 10, 2018

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations

EG(1)