NCT01569035

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

2.5 years

First QC Date

March 24, 2012

Last Update Submit

January 6, 2021

Conditions

Oligohydramnios

Keywords

oligohudramniosoral anti coagulantDopplar ultrasound

Outcome Measures

Primary Outcomes (1)

  • The primary outcome was improvement of the amniotic fluid and improving the biophysical profile

    The primary outcome was improvement of the amniotic fluid and improving the biophysical profile

    2 to 3 three weeks

Secondary Outcomes (1)

  • The secondary outcome is prolongation of pregnancy till suitable time of fetal maturity

    4 weeks

Study Arms (1)

warfarin

ACTIVE COMPARATOR

oral anti coagulant

Drug: warfarin

Interventions

warfarinDRUG

3 mg warfarin oral tablet for 2 to 3 weeks

Also known as: coumarins
warfarin

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • anaemia,
  • cardiac diseases,or
  • history of premature rupture of membrane or
  • structural malformations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Oligohydramnios

Interventions

WarfarinCoumarins

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Alaa M Ismail, M.D

    Women Health Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

March 24, 2012

First Posted

April 2, 2012

Study Start

January 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 7, 2021

Record last verified: 2021-01

Locations

EG(1)