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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Premature Rupture of Membrane Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Use of Beta Subunit of Human Chorionic Gonadotropin Assay as a Diagnostic Tool for Premature Rupture of Membranes
Actual Study Start Date : April 10, 2017
Actual Primary Completion Date : June 29, 2017
Actual Study Completion Date : July 7, 2017

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Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   17 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106311


Locations
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Egypt
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
Cairo, Greater Cairo, Egypt, 11956
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Eman Omran, M.D. Cairo University
More Information
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Responsible Party: Eman Omran, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03106311    
Other Study ID Numbers: 4567
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
 Pregnancy Complications
Wounds and Injuries
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs