NCT03824873

Brief Summary

40 pregnant females at term diagnosed with morbidly adherent placenta and planned for elective cesarean section were recruited and randomized to 2 groups. Group A: Internal iliac ligation followed by cesarean hysterectomy. Group B: cesarean hysterectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2017

Typical duration for phase_3

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

Study Start

First participant enrolled

March 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

2.8 years

First QC Date

January 26, 2019

Last Update Submit

July 7, 2020

Conditions

Blood Loss

Keywords

Internal iliac arteryInternal iliac artery ligationPlacenta previaPlacenta accretacesarean hysterectomy

Outcome Measures

Primary Outcomes (2)

  • Amount of blood loss

    intraoperative

  • Amount of Blood transfusion needed in mililiters

    24 hours

Secondary Outcomes (4)

  • change of hemoglobin

    24 hours

  • change of hematocrit

    24 hours

  • operative time

    intraoperative

  • incidence of injury of important structures during operation

    intraoperative

Study Arms (2)

internal iliac artery ligation + cesarean hysterectomy

ACTIVE COMPARATOR
Procedure: Internal iliac artery ligationProcedure: cesarean hysterectomy

cesarean hysterectomy

ACTIVE COMPARATOR
Procedure: cesarean hysterectomy

Interventions

Internal iliac artery ligationPROCEDURE

Internal iliac artery ligation and cesarean hysterectomy

Also known as: cesarean hysterectomy
internal iliac artery ligation + cesarean hysterectomy
cesarean hysterectomyPROCEDURE

cesarean hysterectomy

cesarean hysterectomyinternal iliac artery ligation + cesarean hysterectomy

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Placenta previa accreta
  • Previous 2 cesarean section
  • completed her family
  • Hemoglobin \> 11 gm/dl
  • Elective cesarean hysterectomy

You may not qualify if:

  • Anemia ( Hemoglobin \< 11 gm/dl)
  • Not completed her family
  • BMI \> 35 Kg/m2
  • Bleeding tendency
  • Emergengy cesarean section
  • Thrombophilia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

HemorrhagePlacenta PreviaPlacenta Accreta

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 26, 2019

First Posted

January 31, 2019

Study Start

March 1, 2017

Primary Completion

January 1, 2020

Study Completion

July 2, 2020

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)