NCT03327818

Brief Summary

AIM OF THE WORK The aim of the study is to compare the maternal morbidity and mortality between obstetric hysterectomy and conservative surgery for pregnant ladies \> 28 weeks with placenta accreta during caesarean section at Ain Shams University Maternity Hospital in the last five years and prospective study in the next six months. Hypothesis In women with placenta accrete undergoing hysterectomy may be similar to conservative surgery as regard maternal morbidity and mortality.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
491

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

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

Study Start

First participant enrolled

June 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

October 27, 2017

Last Update Submit

October 27, 2017

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

  • maternal morbidity

    24 hours post operative

Study Arms (2)

conservative surgery group

Procedure: uterine conservative study

hysterectomy group

Procedure: hysterectomy

Interventions

hysterectomyPROCEDURE
hysterectomy group
uterine conservative studyPROCEDURE
conservative surgery group

Eligibility Criteria

Age14 Years - 55 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

all cases of placenta accreta present in Ain shams university maternity hospital from 2011 to 2015 and from July 2016 to January 2017

You may qualify if:

  • Women admitted for elective caesarean section. Pregnant women more than 28weeks of gestation. Women with no associated medical diseases eg. DM, PET. Pre-operatively Hemodynamically stable women. Women diagnosed with placenta accrete either preoperative or accidentally discovered intraoperative.

You may not qualify if:

  • Pregnant women less than 28weeks of gestation. Women with associated medical co-morbidity eg bleeding tendency eg: DM, PET.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Placenta Accreta

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Malames Mahmoud Faisal ,MD

Study Record Dates

First Submitted

October 27, 2017

First Posted

October 31, 2017

Study Start

June 1, 2016

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

October 31, 2017

Record last verified: 2017-10