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Warfarine in Unexplained Oligohydramnios

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01569035
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : September 21, 2012
Sponsor:
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt

Brief Summary:
This study examines using oral anti coagulant warfarin in the management of unexplained oligohydramnios improve the perinatal outcome with little or no complications to the mother or the neonates.

Condition or disease Intervention/treatment Phase
Oligohydramnios Drug: warfarin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: a Randomized Clinical Trial Using Oral Anti Coagulant in the Management of Unexplained Oligohydramnios
Study Start Date : January 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: warfarin
oral anti coagulant
Drug: warfarin
3 mg warfarin oral tablet for 2 to 3 weeks
Other Name: coumarins




Primary Outcome Measures :
  1. The primary outcome was improvement of the amniotic fluid and improving the biophysical profile [ Time Frame: 2 to 3 three weeks ]
    The primary outcome was improvement of the amniotic fluid and improving the biophysical profile


Secondary Outcome Measures :
  1. The secondary outcome is prolongation of pregnancy till suitable time of fetal maturity [ Time Frame: 4 weeks ]
    The baseline characteristics of the study participants were analyzed including amniotic fluid index, Doppler indices changes of the fetal and maternal vessles, mode of the delivery and the rate of continuation of pregnancy. Finally, the maternal and neonatalcomplications and the cost of the treatment were calculated.intention to treat analysis is done.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients were eligible for inclusion if they were 28th to 32nd weeks of pregnancy and
  • age 18-35 years and
  • diagnosed to have idiopathic oligohydramnios excluded by medical history and
  • detailed u/s examination,
  • the cut off AFI was less than 5cm

Exclusion Criteria:

  • Exclusion criteria were chronic hypertension,
  • anaemia,
  • cardiac diseases,or
  • history of premature rupture of membrane or
  • structural malformations.

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 ClinicalTrials.gov identifier (NCT number): NCT01569035


Locations
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Egypt
Women Health Hospital
Assiut, Egypt
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
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Principal Investigator: Alaa M Ismail, M.D Women Health Hospital

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Responsible Party: alaa eldeen mahmoud ismail, doctor, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT01569035    
Other Study ID Numbers: wuoh
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: September 21, 2012
Last Verified: September 2012
Keywords provided by alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt:
oligohudramnios
oral anti coagulant
Dopplar ultrasound
Additional relevant MeSH terms:
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Oligohydramnios
Pregnancy Complications
Warfarin
Anticoagulants
Coagulants