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

Cairo University (CU)

Status: Completed

Conditions: Premature Rupture of Membrane

Treatments: Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT03106311

4567

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: Female

Ages: 17 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Rupture of membranes group

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin

Intact membranes group

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin