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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03106311

Enrollment

100

Registered

2017-04-10

Start date

2017-04-10

Completion date

2017-07-07

Last updated

2017-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Rupture of Membrane

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

Interventions

DIAGNOSTIC_TESTassessment of beta subunit of human chorionic gonadotropin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

17 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026