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Warfarine in Unexplained Oligohydramnios

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier:
NCT01569035
First received: March 24, 2012
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Oligohydramnios
 Drug: warfarin
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: a Randomized Clinical Trial Using Oral Anti Coagulant in the Management of Unexplained Oligohydramnios

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Woman's Health University Hospital, Egypt:

Primary Outcome Measures:
  • The primary outcome was improvement of the amniotic fluid and improving the biophysical profile [ Time Frame: 2 to 3 three weeks ] [ Designated as safety issue: Yes ]
    The primary outcome was improvement of the amniotic fluid and improving the biophysical profile


Secondary Outcome Measures:
  • The secondary outcome is prolongation of pregnancy till suitable time of fetal maturity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 200
Study Start Date: January 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: warfarin
oral anti coagulant
 Drug: warfarin
3 mg warfarin oral tablet for 2 to 3 weeks
Other Name: coumarins

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569035

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

No publications provided

Responsible Party: alaa eldeen mahmoud ismail, doctor, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT01569035     History of Changes
Other Study ID Numbers: wuoh
Study First Received: March 24, 2012
Last Updated: September 20, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by Woman's Health University Hospital, Egypt:
oligohudramnios
oral anti coagulant
Dopplar ultrasound

Additional relevant MeSH terms:
Oligohydramnios
Pregnancy Complications
Anticoagulants
Warfarin
 Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013