NCT03372538

Brief Summary

comparative study between the incidence of urological injury in case of placenta accreta in cases where urological surgical staff are participating in the operation from the start and in cases where the operation is carried by the gynecological staff only

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

December 13, 2017

Status Verified

December 1, 2017

Enrollment Period

3 months

First QC Date

December 9, 2017

Last Update Submit

December 9, 2017

Conditions

Placenta Accreta

Keywords

placenta accreta

Outcome Measures

Primary Outcomes (1)

  • urological injury

    badder or ureteric injury

    intraoperative

Study Arms (2)

multidisciplinary team group

500 patients of placenta accreta managed by obstetricans and urologists

Procedure: cesarean section or cesarean hysterectomy

obstetricians only group

500 patients of placenta accreta managed by obstetricans only

Procedure: cesarean section or cesarean hysterectomy

Interventions

cesarean section or cesarean hysterectomyPROCEDURE

upper segment cesarean section and or cesarean hysteroctomy

multidisciplinary team groupobstetricians only group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

1000 patients pregnant 38 weeks with placenta accreta

You may qualify if:

  • pregnant 38 weeks
  • placenta accreta

You may not qualify if:

  • medical disorders complicating pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

December 9, 2017

First Posted

December 13, 2017

Study Start

December 1, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

December 13, 2017

Record last verified: 2017-12

Locations

EG(1)