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

Not Applicable

Completed

• Conditions: Premature Rupture of Membrane
• Interventions: Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin

• Registration Number: NCT03106311
• Lead Sponsor: Cairo University

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-04
• Study Start: 2017-04-10
• Study First Posted: 2017-04-10
• Primary Completion: 2017-06-29
• Status Verified: 2017-07
• Study Completion: 2017-07-07
• Last Update Submitted: 2017-07-07
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

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Exclusion Criteria

• Presence of vaginal bleeding
• Presence of any obstetric emergency as cord prolapse

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rupture of membranes group	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	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.

Primary Outcome Measures

Name	Time	Method
Concentration of beta subunit of human chorionic gonadotropin	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	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

Secondary Outcome Measures

Name	Time	Method
Presence or absence of positive qualitative pregnancy test	Qualitative pregnancy test will be done in the vaginal washing fluid by an investigator within 20 minutes from admission to the Obstetrics department.	Qualitative pregnancy test will be done by an investigator in the Obstetrics department

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital; 🇪🇬 Cairo, Greater Cairo, Egypt