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Trial record 16 of 418 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

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

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ClinicalTrials.gov Identifier: NCT03106311
Recruitment Status : Completed
First Posted : April 10, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Eman Omran, Cairo University

Tracking Information
First Submitted Date  ICMJE April 4, 2017
First Posted Date  ICMJE April 10, 2017
Last Update Posted Date July 11, 2017
Actual Study Start Date  ICMJE April 10, 2017
Actual Primary Completion Date June 29, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03106311 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Quantitative Pregnancy Test in Amniotic Fluid as a Diagnostic Tool for Rupture of Fetal Membranes
Official Title  ICMJE Use of Beta Subunit of Human Chorionic Gonadotropin Assay as a Diagnostic Tool for Premature Rupture of Membranes
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Premature Rupture of Membrane
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Rupture of membranes group
    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.
    Intervention: Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin
  • Active Comparator: Intact membranes group
    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: Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 7, 2017
Actual Primary Completion Date June 29, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 17 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03106311
Other Study ID Numbers  ICMJE 4567
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Eman Omran, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eman Omran, M.D. Cairo University
PRS Account Cairo University
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP