Disorder of Amniotic Cavity and/or MembranePROMNCT02111148
Vaginal Fluid Wash in Pre-labour Rupture of Membranes
A study testing Urea and creatinine, Nitrazine and 5ml saline in people with Disorder of Amniotic Cavity and/or Membrane, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The investigators assess in this study the sensitivity of Urea and Creatinine and that of Nitrazine test in vaginal wash after injecting saline in the vagina of patients with pre-labour rupture of membranes Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Disorder of Amniotic Cavity and/or Membrane
- What is being tested?
- Urea and creatinine, Nitrazine and 5ml saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- May 2014to Dec 2021
- 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 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age between 28 and 41 weeks
- Single intrauterine pregnancy
- History of gush of fluid
- Liquor detected on speculum examination
Who cannot join
- Vaginal bleeding
- Patients in labour
- Contaminated samples
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Nesreen Abdel Fattah Abdullah Shehata
Cairo
Nesreen A Shehata, MD
About this study
Official title: Urea and Creatinine Versus Nitrazine Test in Vaginal Fluid Wash in Diagnosed Pre Labour Rupture of Membranes
The investigators assess in this study the sensitivity of Urea and Creatinine and that of Nitrazine test in vaginal wash after injecting saline in the vagina of patients with pre-labour rupture of membranes
Read the detailed description
The aim of this study is to compare the accuracy of measuring the urea and creatinine level versus that of nitrazine test in vaginal wash of pre-labour rupture of membranes patients.Each patient with rupture of membranes will be assessed clinically and then if not in labour , patients will be divided into 2 groups, 5ml saline will be injected in the vagina of each patient in every group then the vaginal wash will be collected in a test tube. Urea and creatinine group, biochemical tests for urea and creatinine in mIU/ml to detect their presence in the wash will be done. In Nitrazine group wash will be assessed by nitrazine paper showing bluish discoloration in rupture membranes. Sensitivity of each test in diagnosed rupture of membranes will be assessed.Which means how many patients in each test show positive results in case of diagnosed case.
- Being tested
- Urea and creatinine, Nitrazine, 5ml saline
- Keywords
- rupture of membranes, nitrazine, urea, creatinine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urea and creatinineProcedure or surgery
the vagina will be washed with 5ml saline, urea and creatinine will be detected biochemically in the vaginal wash.
NitrazineProcedure or surgery
Nitrazine detection in vaginal wash
5ml salineDrug
the vagina will be washed with 5ml saline and vaginal wash will be collected.
| Study group | Role | What they receive |
|---|---|---|
| urea and creatinine | Active comparator | urea and creatinine detected in vaginal fluid wash after injecting of 5 ml saline intavaginally Receives: Procedure: Urea and creatinine |
| Nitrazine | Active comparator | Biochemical description of Nitrazine in the vaginal wash Receives: Procedure: Nitrazine |
| saline | Active comparator | 5ml saline will be injected in vagina of each patient in both groups within 24 hours of membrane rupture. Receives: Drug: 5ml saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urea and creatinine in vaginal fluid
5ml saline will be injected vaginally then vaginal fluid will be collected.
Measured: Within first 24 hours after rupture of membranes in third trimester
Secondary outcomes (1)
Nitrazine test
5ml saline is injected vaginally then vaginal fluid is collected
Measured: Within first 24 hours after rupture of membranes in third trimester
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Amniotic Cavity and/or MembraneStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
- Investigators
- Nesreen A Shehata, MD, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111148
- Sponsor's protocol ID
- Beni-Suef 2
- Acronym
- PROM
- Status last verified
- Feb 2021
- First submitted
- 2 Apr 2014
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urea and Creatinine Versus Nitrazine Test in Vaginal Fluid Wash in Diagnosed Pre Labour Rupture of Membranes
- ClinicalTrials.gov ID
- NCT02111148
- Acronym / sponsor ID
- PROM / Beni-Suef 2
- Keywords
- rupture of membranes, nitrazine, urea, creatinine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- May 2014
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Apr 2014 (estimated)
- 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.
The investigators assess in this study the sensitivity of Urea and Creatinine and that of Nitrazine test in vaginal wash after injecting saline in the vagina of patients with pre-labour rupture of membranes
Detailed description
The aim of this study is to compare the accuracy of measuring the urea and creatinine level versus that of nitrazine test in vaginal wash of pre-labour rupture of membranes patients.Each patient with rupture of membranes will be assessed clinically and then if not in labour , patients will be divided into 2 groups, 5ml saline will be injected in the vagina of each patient in every group then the vaginal wash will be collected in a test tube. Urea and creatinine group, biochemical tests for urea and creatinine in mIU/ml to detect their presence in the wash will be done. In Nitrazine group wash will be assessed by nitrazine paper showing bluish discoloration in rupture membranes. Sensitivity of each test in diagnosed rupture of membranes will be assessed.Which means how many patients in each test show positive results in case of diagnosed case.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| urea and creatinine | Active comparator | Procedure: Urea and creatinineurea and creatinine detected in vaginal fluid wash after injecting of 5 ml saline intavaginally |
| Nitrazine | Active comparator | Procedure: NitrazineBiochemical description of Nitrazine in the vaginal wash |
| saline | Active comparator | Drug: 5ml saline5ml saline will be injected in vagina of each patient in both groups within 24 hours of membrane rupture. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Gestational age between 28 and 41 weeks
- Single intrauterine pregnancy
- History of gush of fluid
- Liquor detected on speculum examination
Key exclusion criteria (3 listed)
- Vaginal bleeding
- Patients in labour
- Contaminated samples
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 |
|---|---|---|
| Urea and creatininethe vagina will be washed with 5ml saline, urea and creatinine will be detected biochemically in the vaginal wash. | Procedure or surgery | urea and creatinine |
| NitrazineNitrazine detection in vaginal wash | Procedure or surgery | Nitrazine |
| 5ml salinethe vagina will be washed with 5ml saline and vaginal wash will be collected. | Drug | saline |
Primary outcome
Urea and creatinine in vaginal fluid
Time frame: Within first 24 hours after rupture of membranes in third trimester
5ml saline will be injected vaginally then vaginal fluid will be collected.
1 secondary outcome
Nitrazine test
Time frame: Within first 24 hours after rupture of membranes in third trimester
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
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.
Nesreen A Shehata, MD principal investigator
Beni-Suef 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 Urea and creatinine, Nitrazine and 5ml saline in people with Disorder of Amniotic Cavity and/or Membrane, run by Beni-Suef 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nesreen A Shehata, MD (00201024150605, nesoomar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urea and creatinine in vaginal fluid (time frame: Within first 24 hours after rupture of membranes in third trimester). 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 16 Feb 2021.