Premature Rupture of MembraneNCT03106311
The Use of Quantitative Pregnancy Test in Amniotic Fluid as a Diagnostic Tool for Rupture of Fetal Membranes
A study testing assessment of beta subunit of human chorionic gonadotropin in people with Premature Rupture of Membrane, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 45 years, women only
- Conditions the study is for
- Premature Rupture of Membrane
- What is being tested?
- assessment of beta subunit of human chorionic gonadotropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2017to 7 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Presence of vaginal bleeding
- Presence of any obstetric emergency as cord prolapse
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
Cairo, Greater Cairo, 11956
About this study
Official title: Use of Beta Subunit of Human Chorionic Gonadotropin Assay as a Diagnostic Tool for Premature Rupture of Membranes
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.
Read the 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
- Conditions
- Premature Rupture of Membrane
- Being tested
- assessment of beta subunit of human chorionic gonadotropin
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of beta subunit of human chorionic gonadotropinDiagnostic test
Vaginal washing fluid will be collected and sent for measurement of beta subunit of human chorionic gonadotropin
| Study group | Role | What they receive |
|---|---|---|
| Rupture of membranes group | Active comparator | 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. Receives: Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin |
| Intact membranes group | Active comparator | 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. Receives: Diagnostic Test: assessment of beta subunit of human chorionic gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (1)
Presence or absence of positive qualitative pregnancy test
Qualitative pregnancy test will be done by an investigator in the Obstetrics department
Measured: Qualitative pregnancy test will be done in the vaginal washing fluid by an investigator within 20 minutes from admission to the Obstetrics department.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start10 Apr 2017
- Primary completion29 Jun 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Rupture of MembraneStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Omran, Cairo University
- Investigators
- Eman Omran, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106311
- Sponsor's protocol ID
- 4567
- Status last verified
- Jul 2017
- First submitted
- 4 Apr 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Beta Subunit of Human Chorionic Gonadotropin Assay as a Diagnostic Tool for Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT03106311
- Acronym / sponsor ID
- 4567
- Conditions
- Premature Rupture of Membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rupture of membranes group | Active comparator | Diagnostic Test: assessment of beta subunit of human chorionic gonadotropinPregnant 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. |
| Intact membranes group | Active comparator | Diagnostic Test: assessment of beta subunit of human chorionic gonadotropinPregnant 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. |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Presence of vaginal bleeding
- Presence of any obstetric emergency as cord prolapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of beta subunit of human chorionic gonadotropinVaginal washing fluid will be collected and sent for measurement of beta subunit of human chorionic gonadotropin | Diagnostic test | Intact membranes group, Rupture of membranes group |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Omran, M.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assessment of beta subunit of human chorionic gonadotropin in people with Premature Rupture of Membrane, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.