Back to resultsModified Cervical Inversion During CS in Placenta Previa
Primary Purpose
Placenta Previa
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cervical inversion
Sponsored by
About this trial
This is an interventional prevention trial for Placenta Previa
Eligibility Criteria
Inclusion Criteria:
- pregnant women 38 weeks or more with placenta previa
Exclusion Criteria:
- pregnant ladies with normally implanted placenta or placenta accreat , increta or percreta
Sites / Locations
- Algazeerah and helwan university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
cervical inversion
no cervical inversion
Arm Description
Outcomes
Primary Outcome Measures
The number of women whose placental bed bleeding will be controlled by cervical inversion cervical inversion
how can the cervical inversion technique controls the placental bed bleeding
Secondary Outcome Measures
Full Information
NCT ID
NCT03772184
First Posted
December 10, 2018
Last Updated
February 20, 2022
Sponsor
Aljazeera Hospital
Collaborators
Suez Canal University
1. Study Identification
Unique Protocol Identification Number
NCT03772184
Brief Title
Modified Cervical Inversion During CS in Placenta Previa
Official Title
Alalfy Modofied Cervical Inversion During CS in Placenta Previa
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
May 12, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aljazeera Hospital
Collaborators
Suez Canal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There is an increasing rates of placenta previa nowadays
Detailed Description
several techniques were described to control bleeding .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Using cervical inversion during cesarean section
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cervical inversion
Arm Type
Active Comparator
Arm Title
no cervical inversion
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Cervical inversion
Intervention Description
inverting the cervical lip after delivery
Primary Outcome Measure Information:
Title
The number of women whose placental bed bleeding will be controlled by cervical inversion cervical inversion
Description
how can the cervical inversion technique controls the placental bed bleeding
Time Frame
within an hour
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women with placenta previa
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pregnant women 38 weeks or more with placenta previa
Exclusion Criteria:
pregnant ladies with normally implanted placenta or placenta accreat , increta or percreta
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, PhD
Organizational Affiliation
National research centre , Aljazeerah hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algazeerah and helwan university
City
Giza
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Modified Cervical Inversion During CS in Placenta Previa
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