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Early Versus Late Post Caesarean Section Oral Anticoagulation Initiation and Risk of Maternal Complications in Patients With Mechanical Heart Valve Prosthesis

NCT04855110 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2021-04-22

No results posted yet for this study

Summary

A randomized cohort study applied to patients with mechanical heart valve prosthesis who will be delivered by caesarean section at or after 28 weeks of gestation . Using a table of random numbers, participants will be divided into 2 equal groups. Group A (57 patients) in which warfarin will be started day 2 after caesarean delivery (i.e. 24 hours postoperative), and group B (57 patients) in which warfarin will be started day 5 after caesarean delivery, then maternal complications are compared among these 2 groups.

Conditions

  • Maternal Complications After Oral Anticoagulation When Initiated Early and Late After Caesarean Section Done for Patients With Mechanical Heart Valve Prosthesis

Interventions

DRUG

Warfarin Sodium started on Day 2 after caesarean section (in a dose that achieves a therapeutic level as indicated by the cardiology consultant)

Warfarin started on day 2 after caesarean section in patients with mechanical heart valve prosthesis

DRUG

Warfarin Sodium started on day 5 after caesarean section (in a dose that achieves a therapeutic level as indicated by the cardiology consultant)

Warfarin started on day 5 after caesarean section in patients with mechanical heart valve prosthesis

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Maged A Abdel Raouf, professor · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04855110 on ClinicalTrials.gov