Use of Beta Subunit of Human Chorionic Gonadotropin Assay as a Diagnostic Tool for Premature Rupture of Membranes
| Registry | NCT03106311 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: double, diagnostic |
| Enrollment | 100 (Actual) |
| Sponsor | Cairo University (Other) |
| Conditions | Premature Rupture of Membrane |
| Interventions | assessment of beta subunit of human chorionic gonadotropin (Diagnostic test) |
| Dates | start 2017-04-10, primary completion 2017-06-29, completion 2017-07-07, first posted 2017-04-10, last updated 2017-07-11 |
| Locations | 1 site in Egypt |
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All trials for Premature Rupture of Membrane All trials of assessment of beta subunit of human chorionic gonadotropin
Two groups will be recruited. The first group are pregnant ladies that have unequivocal rupture of fetal membranes that is diagnosed by seeing the amniotic fluid leakage in the vagina. The second group are normal pregnant ladies without rupture of membranes. both groups will be tested by taking vaginal washing fluid. Quantitative and qualitative pregnancy tests will be measured in this fluid.
Beta subunit of human chorionic gonadotropin assay will be measured in the vaginal washing in two groups. The first group are pregnant women in the second or third trimester. These women have definite rupture of membranes diagnosed by visual leaking of the amniotic fluid from the cervix during speculum examination. The second group are pregnant women with intact membranes. Assessment of both the qualitative and quantitative beta subunit of human chorionic gonadotropin will be done
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Rupture of membranes group | Active comparator | Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin | Pregnant women with definite rupture of membranes will undergo speculum examination. Vaginal washing will be done. The washing fluid will be taken for quantitative and qualitative assessment of beta subunit of human chorionic gonadotropin. |
| Intact membranes group | Active comparator | Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin | Pregnant women with intact membranes will undergo speculum examination. Vaginal washing will be done. The washing fluid will be taken for quantitative and qualitative assessment of beta subunit of human chorionic gonadotropin. |
Sex: Female, ages: 17 Years to 45 Years
Inclusion Criteria: * Pregnant women between 14 and 40 weeks gestation with history of gush of vaginal fluid * Pregnant women between without history of gush of vaginal fluid Exclusion Criteria: * Presence of vaginal bleeding * Presence of any obstetric emergency as cord prolapse
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital | Cairo, Greater Cairo | Egypt |