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Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03789903
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Information provided by (Responsible Party):
Radwa Rasheedy Ali, Ain Shams University

Brief Summary:
AF lactate level could help in predicting the duration from ROM till delivery

Condition or disease Intervention/treatment Phase
Rupture of Membranes; Premature Diagnostic Test: amniotic fluid lactate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Amniotic Fluid Lactate in Predicting Latency in Perterm Premature Rupture of Membranes
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Intervention Details:
  • Diagnostic Test: amniotic fluid lactate
    AF lactate

Primary Outcome Measures :
  1. latency period [ Time Frame: upto 48 hours ]
    duration from ROM till the occurrence of active labor

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03789903

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Contact: Radwa R Ali, MD 01283492979 ext 02002

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AinShams university maternity hospital Recruiting
Cairo, Abbassya, Egypt, 11566
Contact: Ahmed K Maklad, MD         
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Radwa Rasheedy Ali, Principal Investigator, Ain Shams University Identifier: NCT03789903     History of Changes
Other Study ID Numbers: ain shams maternity hos
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Fetal Membranes, Premature Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries