NCT03137810

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

April 4, 2017

Last Update Submit

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

EXPERIMENTAL

In 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.

Procedure: placental cord drainage

Non placental cord drainage

ACTIVE COMPARATOR

In 90 women after vaginal delivery of the baby placental end of the cut umbilical cord will be kept clamped.

Procedure: non placemtal cord drainage

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.

placental cord drainage

In 90 women after vaginal delivery of the baby placental end of the cut umbilical cord will be kept clamped.

Non placental cord drainage

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

RECRUITING

Study Officials

  • Hassan A Bayoumy, MD

    Ain Shams University

    STUDY CHAIR
  • Amgad E Abou-Gamrah, MD

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

Ahmed A ElShahawy, MD

CONTACT

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

Locations