NCT03772184

Brief Summary

There is an increasing rates of placenta previa nowadays

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

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

December 10, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 10, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

December 10, 2018

Last Update Submit

February 20, 2022

Conditions

Placenta Previa

Outcome Measures

Primary Outcomes (1)

  • 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

    within an hour

Study Arms (2)

cervical inversion

ACTIVE COMPARATOR
Procedure: Cervical inversion

no cervical inversion

NO INTERVENTION

Interventions

Cervical inversionPROCEDURE

inverting the cervical lip after delivery

cervical inversion

Eligibility Criteria

Age22 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women with placenta previa
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant women 38 weeks or more with placenta previa

You may not qualify if:

  • pregnant ladies with normally implanted placenta or placenta accreat , increta or percreta

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah and helwan university

Giza, Egypt

Location

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • Mahmoud Alalfy, PhD

    National research centre , Aljazeerah hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Using cervical inversion during cesarean section
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Obstetrics and Gyneology , National Research Centre

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 11, 2018

Study Start

January 10, 2019

Primary Completion

May 12, 2019

Study Completion

May 15, 2019

Last Updated

February 22, 2022

Record last verified: 2022-02

Locations

EG(1)