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Uterine Artery Ligation to Decrease Blood Loss With Central Placenta Previa

Primary Purpose

Placenta Previa Without Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Uterine artery ligation
Sponsored by
Minia Maternity University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Previa Without Hemorrhage focused on measuring placenta previa, uterine artery ligation

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasound
  • Symptomatic Placenta previa with at least one episode of bleeding
  • Estimated gestational age within 28 to 40 weeks
  • Maternal age > 18 years
  • Informed consent
  • Social affiliation

Exclusion Criteria:

  • Premature rupture of membranes
  • Severe bleeding.
  • Abnormal fetal heart rates.
  • Pre-eclampsia, chorioamnionitis, severe chronic renal disease.

Sites / Locations

  • Minia Maternity University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ligation group

Control group

Arm Description

Uterine artery ligation will be done for patients in this group

Conventional CS

Outcomes

Primary Outcome Measures

Changes in hemoglobin level
Changes in hemoglobin level before and after CS will reflect the amount of blood loss during operation

Secondary Outcome Measures

Degree of uterine contractility.

Full Information

First Posted
November 18, 2013
Last Updated
March 14, 2016
Sponsor
Minia Maternity University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02002026
Brief Title
Uterine Artery Ligation to Decrease Blood Loss With Central Placenta Previa
Official Title
Uterine Artery Ligation to Minimize Blood Loss in Patients With Central Placenta Previa
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia Maternity University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial will address the effect of uterine artery ligation during Cesarean section in cases with placenta previa to decrease blood loss.
Detailed Description
This Study will address the effect of uterine artery ligation prior to fetal delivery during Cesarean section in cases with central placenta previa to guard against postpartum hemorrhage and to minimize blood loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa Without Hemorrhage
Keywords
placenta previa, uterine artery ligation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ligation group
Arm Type
Active Comparator
Arm Description
Uterine artery ligation will be done for patients in this group
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Conventional CS
Intervention Type
Procedure
Intervention Name(s)
Uterine artery ligation
Intervention Description
Uterine artery ligation during cesarean section before delivery of the baby
Primary Outcome Measure Information:
Title
Changes in hemoglobin level
Description
Changes in hemoglobin level before and after CS will reflect the amount of blood loss during operation
Time Frame
hemoglobin level will be done baseline and will be repeated 24 hours after delivery
Secondary Outcome Measure Information:
Title
Degree of uterine contractility.
Time Frame
During CS and within 3 hours after CS

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasound Symptomatic Placenta previa with at least one episode of bleeding Estimated gestational age within 28 to 40 weeks Maternal age > 18 years Informed consent Social affiliation Exclusion Criteria: Premature rupture of membranes Severe bleeding. Abnormal fetal heart rates. Pre-eclampsia, chorioamnionitis, severe chronic renal disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad S Sameer, MD
Organizational Affiliation
Minia Maternity University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minia Maternity University Hospital
City
Minia
ZIP/Postal Code
61111
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
30157787
Citation
Sanad AS, Mahran AE, Aboulfotouh ME, Kamel HH, Mohammed HF, Bahaa HA, Elkateeb RR, Abdelazim AG, El-Din MAZ, Shawki HE. The effect of uterine artery ligation in patients with central placenta pevia: a randomized controlled trial. BMC Pregnancy Childbirth. 2018 Aug 29;18(1):351. doi: 10.1186/s12884-018-1989-5.
Results Reference
derived

Learn more about this trial

Uterine Artery Ligation to Decrease Blood Loss With Central Placenta Previa

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