NCT02405663

Brief Summary

To compare between the effect of controlled cord traction and manual removal of the placenta on blood loss among women undergoing caesarean sections

Trial Health

87
On Track

Trial Health Score

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

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

March 18, 2015

Last Update Submit

May 24, 2017

Conditions

Complications; Cesarean Section

Keywords

blood losscaesarean sectionplacental delivery

Outcome Measures

Primary Outcomes (1)

  • blood loss assessment after placental delivery

    Determine estimated blood loss after placental delivery either by cord traction or manually during caesarean section through comparing pre and postoperative hemoglobin and haematocrit measurements

    12 hours

Secondary Outcomes (6)

  • Placental delivery time.

    30 minutes

  • Duration of operation

    2 hours

  • Need to use ecbolics

    30 minutes

  • Need of blood transfusion

    12 hours

  • Blood loss > 1000 ml

    12 hours

  • +1 more secondary outcomes

Study Arms (2)

manual removal group

EXPERIMENTAL

Group will be assigned for manual removal of the placenta as the surgeon will introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the baby by caesarean section

Procedure: manual removal

cord traction group

EXPERIMENTAL

Group will be assigned for controlled cord traction as the surgeon do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery after the delivery of the baby by caesarean section

Procedure: cord traction

Interventions

manual removalPROCEDURE

one of the standard procedures for placental delivery during caesarean section the surgeon will introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the baby

manual removal group
cord tractionPROCEDURE

one of the standard procedures for placental delivery during caesarean section the surgeon do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery

cord traction group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- All informed and consented women undergoing elective or emergency CS will be legible for enrollment into the study

You may not qualify if:

  • Multiple gestation.
  • Pregnancy below 34 weeks.
  • Severe maternal anemia.
  • Severe pre-eclampsia
  • Prolonged labor.
  • Prolonged rupture of the membranes with fever.
  • Placental abruption.
  • Placenta previa.
  • Placenta accreta.
  • Clotting disorders.
  • Current or previous history of a significant disease including heart disease, liver, renal disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postpartum ward of Armed Forces Hospital, Southern Region

Khamis Mushait, 'Asir Region, 101, Saudi Arabia

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • mohammed ellaithy

    Ain Shams University

    PRINCIPAL INVESTIGATOR

  • haytham atia

    Zagazig University

    PRINCIPAL INVESTIGATOR

  • nuzhat amer

    Armed Forces Hospitals, Southern Region, Saudi Arabia

    PRINCIPAL INVESTIGATOR

  • ahmed altraigey

    Benha University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 18, 2015

First Posted

April 1, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

SA(1)