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Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes

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ClinicalTrials.gov Identifier: NCT03789903
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Radwa Rasheedy Ali, Ain Shams University

Tracking Information
First Submitted Date  ICMJE December 26, 2018
First Posted Date  ICMJE December 31, 2018
Last Update Posted Date December 31, 2018
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
latency period [ Time Frame: upto 48 hours ]
duration from ROM till the occurrence of active labor
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes
Official Title  ICMJE Amniotic Fluid Lactate in Predicting Latency in Perterm Premature Rupture of Membranes
Brief Summary AF lactate level could help in predicting the duration from ROM till delivery
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Rupture of Membranes; Premature
Intervention  ICMJE Diagnostic Test: amniotic fluid lactate
AF lactate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 27, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2019
Estimated Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Radwa R Ali, MD 01283492979 ext 02002 radwaebed@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03789903
Other Study ID Numbers  ICMJE ain shams maternity hos
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radwa Rasheedy Ali, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP