Role of enoxaparin in augmenting the intra-uterine growth in patients with vascular intra-uterine growth retardation
Design
Non-blinded, non-placebo controlled, randomized clinical trial with a sample size of 126 patients
Settings and conduct
This study will be carried out in a tertiary level referral hospital. Women aged >18 years old with singleton pregnancy and diagnosis of intra-uterine growth retardation are randomly allocated to 2 groups. In control group patients receive the routine standard treatments for intrauterine growth retardation. in intervention group, patients receive 4000 IU of enoxaparine daily as SC.
Participants/Inclusion and exclusion criteria
All >18 years old women with singleton pregnancy and diagnosed intra-uterine growth retardation
Intervention groups
4000 IU enoxaparin SC daily
Main outcome variables
Neonatal birth weight
General information
Reason for update
Acronym
IUGR: Intra-Uterine Growth Retardation
IRCT registration information
IRCT registration number:IRCT20180819040830N4
Registration date:2020-05-01, 1399/02/12
Registration timing:registered_while_recruiting
Last update:2020-05-01, 1399/02/12
Update count:0
Registration date
2020-05-01, 1399/02/12
Registrant information
Name
Zahra Naeiji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 2628
Email address
z.naeigi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-26, 1398/10/05
Expected recruitment end date
2020-05-24, 1399/03/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Efficacy and Safety of Enoxaparin in Treatment of Vascular Intra-Uterine Growth Retardation: A Randomized Clinical Trial
Public title
Enoxaparin in Treatment of Vascular Intra-Uterine Growth Retardation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
>18 years old women with singleton pregnant women
Diagnosis of intra-uterine growth retardation for their fetus
Exclusion criteria:
Maternal age <18 years old
Multiple pregnanvy
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Computer-generated block of 4, block randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
--
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Tehran University of Medical Sciences
Street address
Qods St., Bolvar Keshavrz Blv.
City
Tehran
Province
Tehran
Postal code
13354234
Approval date
2019-12-23, 1398/10/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.683
Health conditions studied
1
Description of health condition studied
Intra-uterine growth retardation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Birth weight
Timepoint
At delivery time
Method of measurement
Measuring neonatal birth weight by an electronic scale
Secondary outcomes
1
Description
Enoxaparin side effects (including active bleeding due to enoxaparine use or thrombocytopena after beginning the enoxaparin