PROM (Pregnancy)NCT03435965
PROM by AmnioQuick Duo+ in Egyptian Women
An observational study of PROM (Pregnancy), run by Aljazeera Hospital at 2 sites in Egypt.
Trial summary
Preterm premature rupture of the membranes (PPROM) is responsible for one-third of all preterm births. Optimum treatment relies on accurate diagnosis and gestational age. The diagnosis of PPROM is made by a combination of examination, patient history and some simple tests. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PROM (Pregnancy)
- What is being tested?
- AmnioQuickDuo+
- How many people
- 300 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Nov 2018to 1 Nov 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: - pregnant ladies with PROM from 20- 37 weeks came to the hospital to confirm PROM
Who may be able to join
- pregnant ladies with PROM from 20- 37 weeks
Who cannot join
- Gestational Age >37 wks Non reassuring CTG Signs of chorioamnonitis ( Fever , maternal or fetal tachycardia , Foul cervical discharge , uterine tenderness or high TLC ) Antepartum hemorrhage
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Kasralainy Hospital
Cairo
Ahmed el lithy, M.D, 01120205000, ahmedellithy75@gmail.com
- Recruiting
Algazeerah
Giza
Mahmoud Alalfy, master, +201002611058, mahmoudalalfy@ymail.com
Ahmed Elgazzar, M.D, +201014005959
About this study
Official title: Dilemma for Diagnosis of Amniotic Fluid Leakeage by AmnioQuickDuo+
Preterm premature rupture of the membranes (PPROM) is responsible for one-third of all preterm births. Optimum treatment relies on accurate diagnosis and gestational age. The diagnosis of PPROM is made by a combination of examination, patient history and some simple tests.
Read the detailed description
Premature rupture of the fetal membranes (PROM) is the rupture of the amniotic membranes with release of the amniotic fluid prior to the onset of labour. PROM may be subdivided into term -PROM (TPROM, i.e. PROM after 37 weeks of gestation) and preterm PROM (PPROM, i.e. PROM prior to 37 weeks of gestation). PPROM occurs in approximately 3% of pregnancies and is responsible for a third of all preterm births.The diagnosis of PPROM is made by examination , patient history and simple testing. Patient history has an accuracy of 90% for the diagnosis of PPROM
- Conditions
- PROM (Pregnancy)
- Being tested
- AmnioQuickDuo+
- 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.
AmnioQuickDuo+Diagnostic test
AmnioQuickDuo+ kit for detection of PROM
| Study group | Role | What they receive |
|---|---|---|
| PPROM from 20- less than 28 weeks | pregnant ladies with PROM from 20 - 28 weeks Receives: Diagnostic Test: AmnioQuickDuo+ | |
| PROM from more than 28 weeks - less than 37 weeks | pregnant ladies with PROM from more than 28- less than37 weeks Receives: Diagnostic Test: AmnioQuickDuo+ | |
| control group pregnant ladies in labour after 37 weeks | control group pregnant ladies in labour after 37 weeks with rupture of membrane in labour or in cs Receives: Diagnostic Test: AmnioQuickDuo+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+
the accuracy of amnioQuick to diagnose PROM
Measured: within a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start15 Nov 2018
- Primary completion15 Oct 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PROM (Pregnancy)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital, National Research Centre, Egypt
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435965
- Sponsor's protocol ID
- PROM by AmnioQuick Duo+
- Status last verified
- Aug 2019
- First submitted
- 10 Feb 2018
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data will be shared after finishing the research
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dilemma for Diagnosis of Amniotic Fluid Leakeage by AmnioQuickDuo+
- ClinicalTrials.gov ID
- NCT03435965
- Acronym / sponsor ID
- PROM by AmnioQuick Duo+
- Conditions
- PROM (Pregnancy)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital, National Research Centre, Egypt
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Oct 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 19 Feb 2018 (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.
Preterm premature rupture of the membranes (PPROM) is responsible for one-third of all preterm births. Optimum treatment relies on accurate diagnosis and gestational age. The diagnosis of PPROM is made by a combination of examination, patient history and some simple tests.
Detailed description
Premature rupture of the fetal membranes (PROM) is the rupture of the amniotic membranes with release of the amniotic fluid prior to the onset of labour. PROM may be subdivided into term -PROM (TPROM, i.e. PROM after 37 weeks of gestation) and preterm PROM (PPROM, i.e. PROM prior to 37 weeks of gestation). PPROM occurs in approximately 3% of pregnancies and is responsible for a third of all preterm births.The diagnosis of PPROM is made by examination , patient history and simple testing. Patient history has an accuracy of 90% for the diagnosis of PPROM
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PPROM from 20- less than 28 weeks | – | Diagnostic Test: AmnioQuickDuo+pregnant ladies with PROM from 20 - 28 weeks |
| PROM from more than 28 weeks - less than 37 weeks | – | Diagnostic Test: AmnioQuickDuo+pregnant ladies with PROM from more than 28- less than37 weeks |
| control group pregnant ladies in labour after 37 weeks | – | Diagnostic Test: AmnioQuickDuo+control group pregnant ladies in labour after 37 weeks with rupture of membrane in labour or in cs |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- - pregnant ladies with PROM from 20- 37 weeks came to the hospital to confirm PROM
Key inclusion criteria (1 listed)
- pregnant ladies with PROM from 20- 37 weeks
Key exclusion criteria (1 listed)
- Gestational Age >37 wks Non reassuring CTG Signs of chorioamnonitis ( Fever , maternal or fetal tachycardia , Foul cervical discharge , uterine tenderness or high TLC ) Antepartum hemorrhage
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 |
|---|---|---|
| AmnioQuickDuo+AmnioQuickDuo+ kit for detection of PROM | Diagnostic test | PPROM from 20- less than 28 weeks, PROM from more than 28 weeks - less than 37 weeks, control group pregnant ladies in labour after 37 weeks |
Primary outcome
number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+
Time frame: within a week
the accuracy of amnioQuick to diagnose PROM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Individual participant dataSharing planned: No. the data will be shared after finishing the research
Related trials for PROM (Pregnancy)
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Active, not recruitingPhase 3
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
Premature Rupture of Membrane
RecruitingObservational study
Enhancing Prediction of Adverse Pregnancy Outcomes in Africa Through Partnerships and Innovation
Fetal Growth Restriction (FGR), Preterm Birth
Recruiting
Intravenous Papaverine for Term Prelabor Rupture of Membranes
Premature Rupture of Fetal Membranes
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.
Mahmoud Alalfy principal investigator
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PROM (Pregnancy), run by Aljazeera Hospital at 2 sites 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 1 inclusion and 1 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 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Mahmoud Alalfy (01002611058, mahmoudalalfy@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+ (time frame: within a week). 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 6 Aug 2019.