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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000191190
Enrollment
110
Registered
2019-02-11
Start date
2019-09-11
Completion date
2020-08-02
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Women with ruptured fetal membranes more than 24 and less than 34 weeks without any clinical signs of chorioamnionitis admitted for conservative management will included in this study. Patients included in this study will be subjected to sterile speculum examination for collection of cervico-vaginal secretions for assessment of the interleukin-6 in the cervico-vaginal secretions using the non-invasive Chorioquick bed side test. Chorioquick will be performed on admission and repeated weekly throughout the admission and the conservative management of women with ruptured fetal membranes till the development of the clinical signs of chorioamnionitis necessitate termination of pregnancy or the spontaneous labor pains. Within 48 hours after delivery, placenta, umbilical cord and fetal membranes samples will be obtained for histologic microscopic examination for detection of chorioamnionitis. Chorioquick results will be compared by the results of the histologic examination of the samples collected within 48 hours after delivery (gold standard) to evaluate the non-invasive Chorioquick bed side test in diagnosing sub-clinical chorioamnionitis in women with ruptured fetal membranes less than 34 weeks.

Interventions

The diagnosis of ruptured fetal membranes based on patient’s history, confirmed by visualization of fluid passing from the cervical canal during sterile speculum examination, positive ferning pattern and/or positive nitrazine test and trans-abdominal ultrasound to measure the amniotic fluid index. The gestational age will be calculated from the first day of last menstrual period and confirmed by early ultrasound scan (less than 20 weeks gestation). Patients included in this study will be sub

The diagnosis of ruptured fetal membranes based on patient’s history, confirmed by visualization of fluid passing from the cervical canal during sterile speculum examination, positive ferning pattern and/or positive nitrazine test and trans-abdominal ultrasound to measure the amniotic fluid index. The gestational age will be calculated from the first day of last menstrual period and confirmed by early ultrasound scan (less than 20 weeks gestation). Patients included in this study will be subjected to standard examination, abdominal ultrasound, sterile speculum examination to detect pooling of the amniotic fluid and for collection of the cervical-vaginal fluid using the sterile swab provided in the Chorioquick kits. Then the non-invasive Chorioquick bed side test (Biosynex S.A., Strasbourg) used for assessment of the interleukin-6 in the cervico-vaginal secretions by the labor ward nursing staff. The Result of the Chorioquick bed side test will be detected within 10 minutes. Pregnancy for women with ruptured fetal membranes usually terminated at 34 weeks or at development of the clinical signs of chorioamnionitis necessitate termination of pregnancy. Clinical signs and standard tests of chorioamnionitis necessitate termination of pregnancy include; uterine tenderness, maternal leucocytosis, positive C reactive proteins, pro-calcitonin and leucocyte esterase (laboratory tests repeated twice weekly throughout the conservative treatment of the studied women). Chorioquick will be performed on cervico-vaginal secretions on admission and repeated weekly throughout the admission and the conservative management of all women (non-randomized study) admitted with ruptured fetal membranes less than 34 weeks till the development of the clinical signs of chorioamnionitis necessitate termination of pregnancy or the spontaneous labor pains. Within 48 hours after delivery, placenta, umbilical cord and fetal membranes samples will be obtained for histologic microscopic examination for detection of chorioamnionitis. Presence of inflammatory cells in the samples taken for histologic examination indicate chorioamnionitis. Multiple foci of polymorph nuclear leukocytes (more than or equal 5) in the sub-chorionic fibrin indicate grade 2 inflammation, which is a sensitive indicator of culture-proven amniotic infection (gold standard and the cut-off for chorioamnionitis). Chorioquick results will be compared by the results of the histologic examination of the samples collected within 48 hours after delivery (gold standard) to evaluate the non-invasive Chorioquick bed side test in diagnosing sub-clinical chorioamnionitis in women with ruptured fetak membranes less than 34 weeks.

Sponsors

Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026