- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03789903
Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes
December 27, 2018 updated by: Radwa Rasheedy Ali, Ain Shams University
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Abbassya
-
Cairo, Abbassya, Egypt, 11566
- Recruiting
- Ainshams University maternity hospital
-
Contact:
- Ahmed K Maklad, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women with PPROM
- GA between 24 to 34 weeks
Exclusion Criteria:
- chorioamnionitis
- previous Preterm labor
- abruptio placentae
- UTI ,pyelonephritis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
latency period
Time Frame: upto 48 hours
|
duration from ROM till the occurrence of active labor
|
upto 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Anticipated)
January 1, 2019
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
December 26, 2018
First Submitted That Met QC Criteria
December 27, 2018
First Posted (Actual)
December 31, 2018
Study Record Updates
Last Update Posted (Actual)
December 31, 2018
Last Update Submitted That Met QC Criteria
December 27, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ain shams maternity hos
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.