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

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

Tracking Information

• First Submitted Date: April 4, 2017
• First Posted Date: April 10, 2017
• Last Update Posted Date: July 11, 2017
• Actual Study Start Date: April 10, 2017
• Actual Primary Completion Date: June 29, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT03106311 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Diagnostic
• Condition: Premature Rupture of Membrane

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 4, 2017): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 7, 2017
• Actual Primary Completion Date: June 29, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 17 Years to 45 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03106311
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: Eman Omran, Cairo University
• Study Sponsor: Cairo University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Eman Omran, M.D.; Cairo University

• PRS Account: Cairo University
• Verification Date: July 2017