Warfarine in Unexplained Oligohydramnios

January 6, 2021 updated by: alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt

a Randomized Clinical Trial Using Oral Anti Coagulant in the Management of Unexplained Oligohydramnios

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Assiut, Egypt
        • Women Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: warfarin
oral anti coagulant
3 mg warfarin oral tablet for 2 to 3 weeks
Other Names:
  • coumarins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 to 3 three weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alaa M Ismail, M.D, Women Health Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

March 24, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (ESTIMATE)

April 2, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • wuoh

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oligohydramnios

Clinical Trials on warfarin

Subscribe