NCT04609527

Brief Summary

placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

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

October 15, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

October 15, 2020

Last Update Submit

October 30, 2020

Conditions

Placenta PreviaPlacenta Accreta

Keywords

placentaaccretapraeviahyterectomyPPH

Outcome Measures

Primary Outcomes (2)

  • Failure of the novel conservative management

    Need to do peripartum hysterectomy or patient death

    3 hours

  • Estimated amount of blood loss

    The estimated amount of blood loss during and after surgery

    6 hours

Interventions

Management of placenta accreta spectrumPROCEDURE

Conservative and radical (hysterectomy) treatment of placenta accreta. Follow up to the patients to detect the impact of treatment imposed A novel technique which early identification and repait of uterine wall defects resulted from invasion of the uterine wall by the placenta.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All placenta accreta e high possibility of placenta accrete
  • consent
  • easy follow up visits

You may not qualify if:

  • bleeding tendency
  • associated medical disorder hypertension, diabetes, preeclapsia..

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Osama Abdalmageed

Asyut, Non-US/Non-Canadian, 71111, Egypt

RECRUITING

Assiut University

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta PreviaPlacenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Central Study Contacts

Osama Abdalmageed

CONTACT

01012234876drosamast@aun.edu.eg

maha said

CONTACT

01013464458drmahasaid2014@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: All women with placenta praevia and previous scar in the uterus. Surgical management and follow up will be defined
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 30, 2020

Study Start

October 16, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 3, 2020

Record last verified: 2020-10

Locations

EG(2)