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

Premature Rupture of Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106311
• Other study ID #: 4567
• Status: Completed
• Phase: N/A
• First received: April 4, 2017
• Last updated: July 7, 2017
• Start date: April 10, 2017
• Est. completion date: July 7, 2017

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 7, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Premature Rupture of Membrane
• Rupture

Intervention

Diagnostic Test:
• assessment of beta subunit of human chorionic gonadotropin
Vaginal washing fluid will be collected and sent for measurement of beta subunit of human chorionic gonadotropin

Locations

Country	Name	City	State
Egypt	Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital	Cairo	Greater Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Presence or absence of positive qualitative pregnancy test	Qualitative pregnancy test will be done by an investigator in the Obstetrics department	Qualitative pregnancy test will be done in the vaginal washing fluid by an investigator within 20 minutes from admission to the Obstetrics department.