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

Cairo University100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

100

Conditions

Premature Rupture of Membrane

Interventions

assessment of beta subunit of human chorionic gonadotropinDIAGNOSTIC_TEST

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

Eligibility

Sex: FEMALEMin age: 17 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, Egypt

Outcomes

Primary Outcomes

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

Time frame: 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 Outcomes

Presence or absence of positive qualitative pregnancy test

Qualitative pregnancy test will be done by an investigator in the Obstetrics department

Time frame: Qualitative pregnancy test will be done in the vaginal washing fluid by an investigator within 20 minutes from admission to the Obstetrics department.

Data from ClinicalTrials.gov

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