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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
Ain Shams University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rupture of Membranes; Premature

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. women with PPROM
  2. GA between 24 to 34 weeks

Exclusion Criteria:

  1. chorioamnionitis
  2. previous Preterm labor
  3. abruptio placentae
  4. 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

First Posted
December 26, 2018
Last Updated
December 27, 2018
Sponsor
Ain Shams University
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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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