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

NCT03106311 — Not applicable, Completed, 100 participants, Cairo University

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

RegistryNCT03106311
StatusCompleted
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: double, diagnostic
Enrollment100 (Actual)
SponsorCairo University (Other)
ConditionsPremature Rupture of Membrane
Interventionsassessment of beta subunit of human chorionic gonadotropin (Diagnostic test)
Datesstart 2017-04-10, primary completion 2017-06-29, completion 2017-07-07, first posted 2017-04-10, last updated 2017-07-11
Locations1 site in Egypt

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-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.

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+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

+Arms and interventions

ArmTypeInterventionsDescription
Rupture of membranes groupActive comparatorDiagnostic Test: assessment of beta subunit of human chorionic gonadotropinPregnant 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 groupActive comparatorDiagnostic Test: assessment of beta subunit of human chorionic gonadotropinPregnant 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.
  • assessment of beta subunit of human chorionic gonadotropin (Diagnostic test): Vaginal washing fluid will be collected and sent for measurement of beta subunit of human chorionic gonadotropin

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

Sex: Female, ages: 17 Years to 45 Years

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)

FacilityCityCountryStatus
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospitalCairo, Greater CairoEgypt

+Investigators

My Notes