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NCT03824873 Clinical Trial

Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta

Blood Loss Clinical Trial

Official title:
Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03824873
Other study ID # AS1862
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 1, 2017
Est. completion date July 2, 2020

Study information
Verified date July 2020
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date July 2, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 40 Years
Eligibility Inclusion Criteria:

- Placenta previa accreta

- Previous 2 cesarean section

- completed her family

- Hemoglobin > 11 gm/dl

- Elective cesarean hysterectomy

Exclusion Criteria:

- Anemia ( Hemoglobin < 11 gm/dl)

- Not completed her family

- BMI > 35 Kg/m2

- Bleeding tendency

- Emergengy cesarean section

- Thrombophilia

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Internal iliac artery ligation
Internal iliac artery ligation and cesarean hysterectomy
• cesarean hysterectomy
cesarean hysterectomy

Locations
Country Name City State
Egypt Ain Shams University Maternity Hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amount of blood loss intraoperative
Primary Amount of Blood transfusion needed in mililiters 24 hours
Secondary change of hemoglobin 24 hours
Secondary change of hematocrit 24 hours
Secondary operative time intraoperative
Secondary incidence of injury of important structures during operation incidence of injury of important structures during operation as urinary bladder, ureteric, intestinal or great vessels injury intraoperative
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