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Warfarine in Unexplained Oligohydramnios

This study has been completed.
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt Identifier:
First received: March 24, 2012
Last updated: September 20, 2012
Last verified: September 2012
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
Drug: warfarin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, 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:

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 ]
    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 ]
    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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01569035

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

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

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

Additional relevant MeSH terms:
Pregnancy Complications
Anticoagulants processed this record on April 28, 2017