NCT03117647

Brief Summary

Postpartum hemorrhage is the leading cause of maternal, uterine atony accounts for 75-90% of primary postpartum hemorrhage. The efficacy of the Uterine compression suture in the treatment of atonic postpartum hemorrhage is time-tested and can be said to be almost established .The aim of this study was to assess the role of the Mansoura-VV uterine compression suture as an early intervention in the management of primary atonic postpartum hemorrhage.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

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

Study Start

First participant enrolled

May 1, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

3.6 years

First QC Date

April 7, 2017

Last Update Submit

April 19, 2017

Conditions

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • primary postpartum haemorrhage from atony

    blood loss more than 1000 cc.

    first 24 hours post partum

Interventions

Mansoura-VV compression suturePROCEDURE

two compression suture both are v shaped apex of each suture placed 2 cm below suture line of C.S and 3 cm from the lateral border of the uterus on the right and left side

Eligibility Criteria

Age19 Years - 42 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women diagnosed with primary atonic PPH, during cesarean section when the uterus failed to contract after the routine doses of uterotonics.

You may qualify if:

  • women diagnosed with atonic postpartum hemorrhage at the time of cesarean section after appropriate use of ecobolics

You may not qualify if:

  • patients with placenta previa complete or incomplete centrails, and/or placenta accreta

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • El Refaeey AEA, Abdelfattah H, Mosbah A, Gamal AM, Fayla E, Refaie W, Zaied A, Barakat RI, Seleem AK, Maher M. Is early intervention using Mansoura-VV uterine compression sutures an effective procedure in the management of primary atonic postpartum hemorrhage? : a prospective study. BMC Pregnancy Childbirth. 2017 May 31;17(1):160. doi: 10.1186/s12884-017-1349-x.

    PMID: 28569213DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 18, 2017

Study Start

May 1, 2013

Primary Completion

December 7, 2016

Study Completion

December 7, 2016

Last Updated

April 20, 2017

Record last verified: 2017-04