NCT02656108

Brief Summary

This is a comparative study which will be conducted in Ain Shams University Maternity hospital to assess the individual and specfic role of controlled cord traction as a part of active management of third stage of labor

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
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
2 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

January 12, 2016

Last Update Submit

October 14, 2018

Conditions

Labor Stage, Third

Outcome Measures

Primary Outcomes (1)

  • sever post partum haemorrhage

    blood loss more than 500 cc

    24 hours

Secondary Outcomes (1)

  • duration of third stage of labor

    30 minutes

Study Arms (2)

omiited controlled cord traction

EXPERIMENTAL

neither controlled cord traction nor fundal pressure will be applied. The placenta will be delivered physiologically and signs of placental separation will be awaited

Procedure: Ommited controlled cord traction

controlled cord traction

ACTIVE COMPARATOR

the cord will be held in one hand and the other hand will be placed just above the woman's pubic boneto stabilize the uterus during cord traction

Procedure: controlled cord traction

Interventions

Ommited controlled cord tractionPROCEDURE

No controlled cord traction and no fundal pressure. placenta will be allowed to deliver physiologically

omiited controlled cord traction
controlled cord tractionPROCEDURE

active management of third stage of labor in the form of uterine massage with controlled cord traction

controlled cord traction

Eligibility Criteria

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

You may qualify if:

  • singleton pregnancy
  • term pregnancy

You may not qualify if:

  • episiotomy
  • operative vaginal delivery
  • known coagulation defect
  • Acute complication during labor e.g. eclampsia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

RECRUITING

Study Officials

  • Ahmed M kotb, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed M Kotb, MD

CONTACT

010086819990ahmedmkotp@hotmail.com

ahmed M kotb, MD

CONTACT

1008681999ahmedmkotp@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr. Ahmed Kotb

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 14, 2016

Study Start

January 1, 2018

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)