NCT02728232

Brief Summary

This trial is set to detect the impact of bilateral internal iliac artery ligation on the amount of intra-operative blood loss during the hysterectomy procedure done for the management of abnormally invasive placenta

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

March 31, 2016

Last Update Submit

April 14, 2017

Conditions

Placenta Percreta

Outcome Measures

Primary Outcomes (1)

  • amount of intra-operative hemorrhage

    2-3 hours

Study Arms (2)

Internal Iliac artery ligation group

EXPERIMENTAL

in this group the patients will undergo bilateral internal iliac artery ligation prior to the hysterectomy procedure

Procedure: internal iliac artery ligationProcedure: Cesarean Hysterectomy

Hysterectomy only

ACTIVE COMPARATOR

in this group patients will undergo cesarean hysterectomy only

Procedure: Cesarean Hysterectomy

Interventions

internal iliac artery ligationPROCEDURE
Internal Iliac artery ligation group
Cesarean HysterectomyPROCEDURE
Hysterectomy onlyInternal Iliac artery ligation group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • females with pre-operative diagnosis of abnormally invasive placenta

You may not qualify if:

  • refusal to get enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr el aini hospital

Cairo, Cairo Governorate, 12211, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • Ahmed M Hussein, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 5, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

EG(1)