Omission of Controlled Cord Traction During Active Management of Third Stage of Labor

NCT ID: NCT02656108

Last Updated: 2018-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-11-30

Brief Summary

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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

Detailed Description

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300 patients will be randomized into two groups with controlled cord traction and withoout. The primary outcome will be sever postpartum haemorrhage

Conditions

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Labor Stage, Third

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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omiited controlled cord traction

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

Group Type EXPERIMENTAL

Ommited controlled cord traction

Intervention Type PROCEDURE

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

controlled cord traction

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

Group Type ACTIVE_COMPARATOR

controlled cord traction

Intervention Type PROCEDURE

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

Interventions

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Ommited controlled cord traction

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

Intervention Type PROCEDURE

controlled cord traction

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* singleton pregnancy
* term pregnancy

Exclusion Criteria

* episiotomy
* operative vaginal delivery
* known coagulation defect
* Acute complication during labor e.g. eclampsia
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed El Kotb Abdel Fattah

dr. Ahmed Kotb

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed M kotb, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ahmed M Kotb, MD

Role: CONTACT

010086819990 ext. 0020

ahmed M kotb, MD

Role: CONTACT

1008681999 ext. 0020

Facility Contacts

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ahmed kotb, MD

Role: primary

2001008681999

ahmed kotb

Role: backup

Other Identifiers

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CCO

Identifier Type: -

Identifier Source: org_study_id

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