NCT03668795

Brief Summary

purpose of this study was to report our experience for surgical management of suspected placenta accreta cases encountered in King Hussein medical center

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 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

August 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2014

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

3.2 years

First QC Date

September 11, 2018

Last Update Submit

September 13, 2018

Conditions

To Publish Our Experience in the Surgical Management to Placenta Accreta Cases and the Maternal Outcome

Outcome Measures

Primary Outcomes (1)

  • The intraoperative and short term postoperative complications of surgical interventions in placenta accreta

    Intraoperative visceral injuries, bleeding, and short term postoperative morbidity and mortality

    48 hours

Interventions

Bakrey balloon insertion within the uterus and caesarean hysterectomyPROCEDURE

Creating an intrauterine tamponade to stop the uterine bleeding by inflating an intrauterine balloon with 600 cc of saline versus undergoing hysterectomy if conservative management failed

Also known as: Interventional radiological insertion of balloon to obstuct the internal iliac artery

Eligibility Criteria

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

All pregnant ladies who were diagnosed to have placenta previa accreta cases which was diagnosed using ultrasound or MRI

You may qualify if:

  • all placenta previa accreta cases encountered in our institution over three year period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Mitri Rashed, senior specialist in obstetrics and gynaecology and IVF

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 13, 2018

Study Start

August 1, 2011

Primary Completion

October 30, 2014

Study Completion

November 30, 2017

Last Updated

September 17, 2018

Record last verified: 2018-09