NCT05979181

Brief Summary

The aim of this study is to address the possible preoperative determinants of extrauterine diseases in cases of placenta previa percreta and to compare the operative and postoperative characteristics of cases with and without extrauterine disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

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

Study Start

First participant enrolled

October 20, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

4.3 years

First QC Date

July 30, 2023

Last Update Submit

July 30, 2023

Conditions

Placenta Accreta

Keywords

PASPlacenta previaPlacenta accretaCesarean hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Estimated amount of intraoperative blood loss

    Calculated amount of blood loss during the operation

    From start to end of operation

Study Arms (2)

No extrauterine disease group

Women having placenta previa percreta with no extrauterine disease (FIGO grade 3a)

Procedure: Cesarean hysterectomy

Extrauterine disease group

Women having placenta previa percreta with extrauterine disease (FIGO grades 3b and 3c)

Procedure: Cesarean hysterectomy

Interventions

Cesarean hysterectomyPROCEDURE

Cesarean hysterectomy due to placenta previa percreta with no extrauterine disease (FIGO grade 3a) or with extrauterine disease (FIGO grades 3b and 3c)

Extrauterine disease groupNo extrauterine disease group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who underwent cesarean hysterectomy on placenta previa percreta (FIGO grade 3) diagnosed by color flow Doppler, and confirmed intraoperatively

You may qualify if:

  • Women who underwent cesarean hysterectomy on placenta previa percreta (FIGO grade 3).

You may not qualify if:

  • Medical conditions complicating pregnancy.
  • Blood diseases or bleeding tendencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

MeSH Terms

Conditions

Placenta AccretaPlacenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • Khaled S Ismail, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

  • Mahmoud M Awad, MD

    Mansoura University

    STUDY DIRECTOR

  • Alhussein A Mohamed, MD

    Mansoura University

    STUDY DIRECTOR

  • Mohamed S Abdelhafez, MD

    Mansoura University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2023

First Posted

August 7, 2023

Study Start

October 20, 2018

Primary Completion

February 17, 2023

Study Completion

February 17, 2023

Last Updated

August 7, 2023

Record last verified: 2023-07

Locations

EG(1)