Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01569035 |
| Other study ID # |
wuoh |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
January 2009 |
| Est. completion date |
July 2011 |
Study information
| Verified date |
January 2021 |
| Source |
Woman's Health University Hospital, Egypt |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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 them.
The patients were randomly allocated to 2 treatment groups using computer-generated numbers
in sealed envelopes. Treatment was started immediately after the test result was known, and
continued until 36 completed weeks of pregnancy or active onset of labor. The patients were
randomized to receive either a daily dose of 3 mg warfarin oral tablet or a daily placebo
sachet The placebo sachets were especially manufactured to look identical to warfarin
tablets. The tablets were placed in sacs and then stored in envelopes numbered from 1 to 200
The envelopes were numbered and randomized according to computer-generated randomization
tables to ensure an equal number of patients in each arm. Throughout the trial, access to the
randomization code was available only to the pharmacist who manufactured the placebo and
packed the envelopes and was not available to any of the treating physicians or patients
Treatment protocol:
One tablet of 3 mg of warfarin was provided daily to each patient in Warfarin group and
placebo to Placebo group. After starting the treatment; weekly follow up of the patient for
four weeks till 36 weeks and 2 weeks thereafter. Each follow up visit the following were
done; assessment of the amniotic fluid, biophysical profile including non stress test (NST),
Doppler U/S of fetal ascending aorta, uterine, middle cerebral and umbilical arteries.
Laboratory measurement of prothrombine time and concentration and INR are checked daily until
in the therapeutic range for 2 consecutive days, then twice a week for 1-2 weeks, then weekly
until stable. Change in a patient's condition, e.g. liver disease, intercurrent illness, and
new drug started necessitates more frequent testing. Patients should be advised to report any
bruising or bleeding immediately, as advised, avoid aspirin but use paracetamol for pain
,avoid contact sports and activities carrying a risk of head injury. During labor or cesarean
section visual inspection of blood loss and 48 hours follow up for the occurrence of
hematomas and neonatal follow up for any bleeding problems. Discontinuation of treatment was
done if after two weeks of treatment no changes of the amniotic fluid, manifestation of fetal
distress appeared or the patient completed 36 weeks of gestation.
Assessment of outcome measures The primary outcome was improvement of the amniotic fluid and
improving the biophysical profile. The secondary outcome is prolongation of pregnancy till
suitable time of fetal maturity. 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 neonatal complications and the cost of the treatment were calculated.
Statistical analysis:
. Data collected and analyzed by computer program SPSS version 17 Chicago -USA
- Data expressed as mean ± S.D, number and percentage
- Using Paried t.test to determine significance for numeric variable
- Using Pearson´s correlation to determine significance between variables N.S= P > 0.05 No
significance
- = P < 0.05 Significant.
