NCT02480556

Brief Summary

to compare the blood loss during caesarean section between two different methods of separating the placenta after fetal extraction, keeping in mind that most blood loss occurs after placental separation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
838

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

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

June 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

June 22, 2015

Last Update Submit

March 2, 2016

Conditions

Haemorrhage

Keywords

blood loss; caesarean section ; manual placental separation

Outcome Measures

Primary Outcomes (1)

  • Blood Loss

    10 minutes

Study Arms (2)

Group A

EXPERIMENTAL

manual seperation of the placenta

Procedure: manual seperation of the placenta

Group B

ACTIVE COMPARATOR

Conservative separation of placenta

Procedure: Conservative separation of placenta

Interventions

manual seperation of the placentaPROCEDURE

manual separation of the placenta will be done immediately after fetal extraction \& cord clamping, where the fingers of the surgeon will be insinuated between the margin of the placenta and the uterine cavity, then by sawing movement and controlled traction by the other hand till placenta is separated from the uterine cavity

Group A
Conservative separation of placentaPROCEDURE

Conservative separation of placenta: in group B but following fetal extraction and cord clamping, the placenta will be left insitu \& uterus is massaged awaiting spontaneous placental separation

Group B

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

11562

Ḩadā’iq al Qubbah, Cairo Governorate, 11562, Egypt

Location

Related Publications (2)

  • Gol M, Baloglu A, Aydin C, Ova L, Yensel U, Karci L. Does manual removal of the placenta affect operative blood loss during cesarean section? Eur J Obstet Gynecol Reprod Biol. 2004 Jan 15;112(1):57-60. doi: 10.1016/s0301-2115(03)00278-1.

    PMID: 14687740BACKGROUND

  • AWHONN Practice Brief (2014): Quantification of Blood Loss: AWHONN Practice Brief Number 1. JOGNN, 00, 1-3; 2014. DOI: 10.1111/1552-6909.12519.

    BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed M Kamel, M.D

    Lecturer of obstetrics & gynecology

    PRINCIPAL INVESTIGATOR

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
Lecturer of Obstetrics & gynecology

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 24, 2015

Study Start

July 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 3, 2016

Record last verified: 2015-08

Locations

EG(1)