Rupture of Membranes; PrematureNCT03789903
Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes
A study testing amniotic fluid lactate in people with Rupture of Membranes; Premature, run by Ain Shams University at 1 site in Egypt.
Trial summary
AF lactate level could help in predicting the duration from ROM till delivery Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Rupture of Membranes; Premature
- What is being tested?
- amniotic fluid lactate
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Mar 2019
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with PPROM
- GA between 24 to 34 weeks
Who cannot join
- chorioamnionitis
- previous Preterm labor
- abruptio placentae
- UTI ,pyelonephritis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AinShams university maternity hospital
Cairo, Abbassya, 11566
Ahmed K Maklad, MD
About this study
Official title: Amniotic Fluid Lactate in Predicting Latency in Perterm Premature Rupture of Membranes
AF lactate level could help in predicting the duration from ROM till delivery
- Conditions
- Rupture of Membranes; Premature
- Being tested
- amniotic fluid lactate
- 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.
amniotic fluid lactateDiagnostic test
AF lactate
What is being measured
The primary outcome is the main question the study is designed to answer.
latency period
duration from ROM till the occurrence of active labor
Measured: upto 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of Membranes; PrematureStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rasheedy Ali, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789903
- Sponsor's protocol ID
- ain shams maternity hos
- Status last verified
- Dec 2018
- First submitted
- 26 Dec 2018
- Last updated
- 31 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amniotic Fluid Lactate in Predicting Latency in Perterm Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT03789903
- Acronym / sponsor ID
- ain shams maternity hos
- Conditions
- Rupture of Membranes; Premature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 31 Dec 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.
AF lactate level could help in predicting the duration from ROM till delivery
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women with PPROM
- GA between 24 to 34 weeks
Key exclusion criteria (4 listed)
- chorioamnionitis
- previous Preterm labor
- abruptio placentae
- UTI ,pyelonephritis
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 |
|---|---|---|
| amniotic fluid lactateAF lactate | Diagnostic test | – |
Primary outcome
latency period
Time frame: upto 48 hours
duration from ROM till the occurrence of active labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amniotic fluid lactate in people with Rupture of Membranes; Premature, run by Ain Shams 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 4 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 31 Dec 2018. 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 Radwa R Ali, MD (01283492979 ext. 02002, radwaebed@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
latency period (time frame: upto 48 hours). 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 31 Dec 2018.