Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes
Primary Purpose
Rupture of Membranes; Premature
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
amniotic fluid lactate
Sponsored by
About this trial
This is an interventional diagnostic trial for Rupture of Membranes; Premature
Eligibility Criteria
Inclusion Criteria:
- women with PPROM
- GA between 24 to 34 weeks
Exclusion Criteria:
- chorioamnionitis
- previous Preterm labor
- abruptio placentae
- UTI ,pyelonephritis
Sites / Locations
- AinShams university maternity hospitalRecruiting
Outcomes
Primary Outcome Measures
latency period
duration from ROM till the occurrence of active labor
Secondary Outcome Measures
Full Information
NCT ID
NCT03789903
First Posted
December 26, 2018
Last Updated
December 27, 2018
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT03789903
Brief Title
Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes
Official Title
Amniotic Fluid Lactate in Predicting Latency in Perterm Premature Rupture of Membranes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
March 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
AF lactate level could help in predicting the duration from ROM till delivery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Membranes; Premature
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
amniotic fluid lactate
Intervention Description
AF lactate
Primary Outcome Measure Information:
Title
latency period
Description
duration from ROM till the occurrence of active labor
Time Frame
upto 48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women with PPROM
GA between 24 to 34 weeks
Exclusion Criteria:
chorioamnionitis
previous Preterm labor
abruptio placentae
UTI ,pyelonephritis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Radwa R Ali, MD
Phone
01283492979
Ext
02002
Email
radwaebed@yahoo.com
Facility Information:
Facility Name
AinShams university maternity hospital
City
Cairo
State/Province
Abbassya
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed K Maklad, MD
12. IPD Sharing Statement
Learn more about this trial
Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes
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