Clinical Trial: Warfarine in Unexplained Oligohydramnios
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: a Randomized Clinical Trial Using Oral Anti Coagulant in the Management of Unexplained Oligohydramnios
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.
Detailed Summary:
A randomized controlled study with 200 pregnant women with idiopathic oligohydramnios between 28 and 32 weeks. Women were randomized to receive 3 mg warfarin daily (Warfarin group) or placebo (Placebo group). Outcomes included amniotic fluid index (AFI), duration of pregnancy and perinatal outcomes including Apgar score, Neonatal intensive care admission (NICU).
Patients were eligible for inclusion if they were 28t to 32 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. A written informed consent was taken. Gestational age was determined on the basis of the last menstrual period, confirmed by an ultrasound scan conducted between 6 and 14 weeks of gestation The clinical work-up included a history taken prior to enrollment, examination, obstetric ultrasound evaluation, and biophysical profile taken after 32 weeks of pregnancy Exclusion criteria were chronichypertension, anaemia ,cardiac diseases ,or history of premature rupture of membrane or structural malformations. Sterile speculum examination was done to exclude rupture of membrane. Detailed level 2D ultrasonography to determine the possible etiology and to exclude the multiple pregnancy and fetal death. All fetuses were alive with fetal weight were prior treatment and each follow up visits. Doppler ultrasound for uterine, umbilical and middle cerebral arteries, and fetal ascending aorta was done using resistant index (RI), pulsetilty index (PI) and systolic/diastolic (S/D) ratio before and in each follow up visits. Laboratory tests were obtained included complete blood picture, liver function test, immunological tests to exclude antiphospholipid antibodies was done. After these all patients with unknown major cause were classified as idiopathic oligohydramnios and the treatment started to th
Sponsor: Woman's Health University Hospital, Egypt
Current Primary Outcome: The primary outcome was improvement of the amniotic fluid and improving the biophysical profile [ Time Frame: 2 to 3 three weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: The secondary outcome is prolongation of pregnancy till suitable time of fetal maturity [ Time Frame: 4 weeks ]
Original Secondary Outcome: Same as current
Information By: Woman's Health University Hospital, Egypt
Dates:
Date Received: March 24, 2012
Date Started: January 2009
Date Completion:
Last Updated: September 20, 2012
Last Verified: September 2012
