NCT04287933

Brief Summary

postoperative complications are common after cesarean section

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 26, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2020

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

February 26, 2020

Last Update Submit

February 26, 2020

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • The number of women who will have complications

    How many women who will have complications postoperative

    within 2 weeks

Study Arms (2)

Drain

ACTIVE COMPARATOR
Device: Drain insertion

No drain

NO INTERVENTION

Interventions

Drain insertionDEVICE

insertion of a drain

Drain

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women who will have complications after cesarean sectin
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women undergoing cesarean section

You may not qualify if:

  • Women who deliver by normal vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah

Giza, Egypt

Location

Study Officials

  • Mahmoud Alalfy, PhD

    Algezeera hospitaland National Research Centre ,Egypt

    STUDY CHAIR

Central Study Contacts

Mahmoud Alalfy, PhD

CONTACT

01002611058mahmoudalalfy@ymail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2020

First Posted

February 27, 2020

Study Start

March 2, 2020

Primary Completion

July 3, 2020

Study Completion

August 10, 2020

Last Updated

February 27, 2020

Record last verified: 2020-02

Locations

EG(1)