Interleukin-6 bedside test in detecting chorioamnionitis in women with preterm premature rupture of fetal membranes.

Not Applicable

Completed

• Conditions: Ruptured Fetal Membranes; Chorioamnionitis; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Infection - Other infectious diseases

• Registration Number: ACTRN12619000191190
• Lead Sponsor: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-11
• Study Completion: 2020-09-01
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

Inclusion criteria; women with ruptured fetal membranes more than 24 and less than 34 weeks without any clinical signs of chorioamnionitis (maternal fever, maternal tackycardia, uterine tenderness, maternal leucocytosis, positive C reactive proteins, pro-calcitonin and leucocyte esterase) admitted for conservative management.

Exclusion Criteria

Exclusion criteria; women with multiple pregnancies, less than 24 or more than 34 weeks` gestation, not sure of dates, on antibiotic, fetal compromise, preterm labor, bleeding, evident chorioamnionitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome measures the accuracy of non-invasive Chorioquick test in diagnosing chorioamnionitis by comparing Chorioquick test results to biopsy results[Weekly until discharge from the hospital.];Specificity of the Chorioquick test = True negative ÷ True negative + False positive x 100[Weekly until discharge from the hospital.];Accuracy of the Chorioquick test = True positive + True negative ÷ True positive + True negative + False positive + False negative x 100[Weekly until discharge from the hospital.]

Secondary Outcome Measures

Name	Time	Method
atency interval (time interval in days or weeks) between positive Chorioquick bed side test till the development of clinical chorioamnionitis tests necessitates termination of pregnancy during the conservative management of the cases with ruptured fetal membranes, which detected by using the data-linkage to medical records.<br><br><br>[At discharge from the hospital ]