Back to resultsThe Use of Quantitative Pregnancy Test in Amniotic Fluid as a Diagnostic Tool for Rupture of Fetal Membranes
Primary Purpose
Premature Rupture of Membrane
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
assessment of beta subunit of human chorionic gonadotropin
Sponsored by
About this trial
This is an interventional diagnostic trial for Premature Rupture of Membrane
Eligibility Criteria
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
Sites / Locations
- Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Rupture of membranes group
Intact membranes group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Presence or absence of positive qualitative pregnancy test
Qualitative pregnancy test will be done by an investigator in the Obstetrics department
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03106311
Brief Title
The Use of Quantitative Pregnancy Test in Amniotic Fluid as a Diagnostic Tool for Rupture of Fetal Membranes
Official Title
Use of Beta Subunit of Human Chorionic Gonadotropin Assay as a Diagnostic Tool for Premature Rupture of Membranes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
July 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Rupture of Membrane
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rupture of membranes group
Arm Type
Active Comparator
Arm 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.
Arm Title
Intact membranes group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
assessment of beta subunit of human chorionic gonadotropin
Intervention Description
Vaginal washing fluid will be collected and sent for measurement of beta subunit of human chorionic gonadotropin
Primary Outcome Measure Information:
Title
Concentration of beta subunit of human chorionic gonadotropin
Description
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
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
Secondary Outcome Measure Information:
Title
Presence or absence of positive qualitative pregnancy test
Description
Qualitative pregnancy test will be done by an investigator in the Obstetrics department
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Omran, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
City
Cairo
State/Province
Greater Cairo
ZIP/Postal Code
11956
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Use of Quantitative Pregnancy Test in Amniotic Fluid as a Diagnostic Tool for Rupture of Fetal Membranes
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