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

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Ages Eligible for Study: | 17 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
Egypt | |
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital | |
Cairo, Greater Cairo, Egypt, 11956 |
Principal Investigator: | Eman Omran, M.D. | Cairo University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |