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OpenTrials
Completed

NCT Number: NCT03106311

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

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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Key information

Conditions

Premature Rupture of Membrane Female Urogenital Diseases and Pregnancy Complications Fetal Membranes, Premature Rupture Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

17 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, 11956, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Concentration of beta subunit of human chorionic gonadotropin

    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

    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

  1. Presence or absence of positive qualitative pregnancy test

    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.

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 10, 2017
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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