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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-10

Study Completion Date

2017-07-07

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.

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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

Conditions

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Premature Rupture of Membrane

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Rupture of membranes group

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.

Group Type ACTIVE_COMPARATOR

assessment of beta subunit of human chorionic gonadotropin

Intervention Type DIAGNOSTIC_TEST

Vaginal washing fluid will be collected and sent for measurement of beta subunit of human chorionic gonadotropin

Intact membranes group

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.

Group Type ACTIVE_COMPARATOR

assessment of beta subunit of human chorionic gonadotropin

Intervention Type DIAGNOSTIC_TEST

Vaginal washing fluid will be collected and sent for measurement of beta subunit of human chorionic gonadotropin

Interventions

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assessment of beta subunit of human chorionic gonadotropin

Vaginal washing fluid will be collected and sent for measurement of beta subunit of human chorionic gonadotropin

Intervention Type DIAGNOSTIC_TEST

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