The Use of Quantitative Pregnancy Test in Amniotic Fluid as a Diagnostic Tool for Rupture of Fetal Membranes

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Use of Beta Subunit of Human Chorionic Gonadotropin Assay as a Diagnostic Tool for Premature Rupture of Membranes

Conditions
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Premature Rupture of Membrane

Intervention / Treatment
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* Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rupture of membranes group<br>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. | Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin<br>* Vaginal washing fluid will be collected and sent for measurement of beta subunit of human chorionic gonadotropin<br>|
| Active Comparator: Intact membranes group<br>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. | Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin<br>* Vaginal washing fluid will be collected and sent for measurement of beta subunit of human chorionic gonadotropin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of beta subunit of human chorionic gonadotropin | Concentration of beta subunit of human chorionic gonadotropin will be measured in vaginal washing fluid. The collection of vaginal washing fluid will be done by an investigator | This outcome will be measured within 20 minutes of collection of vaginal washing fluid. The collection of vaginal washing fluid will be done by an investigator upon admission to the department of Obstetrics | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of positive qualitative pregnancy test | Qualitative pregnancy test will be done by an investigator in the Obstetrics department | Qualitative pregnancy test will be done in the vaginal washing fluid by an investigator within 20 minutes from admission to the Obstetrics department. |