Aspirin in Asymmetrically Intrauterine Growth
Primary Purpose
Intrauterine Growth Restriction Asymmetrical
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Intrauterine Growth Restriction Asymmetrical
Eligibility Criteria
Inclusion Criteria:
- The pregnant women
- 28-30 weeks
- Idiopathic asymmetrically intrauterine growth restriction
- Middle aged women (20-35 years)
- Women with abnormal umbilical artery Doppler flow indices ( > +2 standard deviation above mean for gestational age)
Exclusion Criteria:
- Women less than 20 and more than 35 years
- hypertensive or diabetic women
- any type of smoking
- multiple pregnancies
- amniotic fluid index <5 cm
- premature pre-labor rupture of membranes
- abnormal placenta
- any fetal congenital malformations.
- women had absent diastolic flow or reversed flow in umbilical artery at the time of recruitment.
Sites / Locations
- Women Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Aspirin group
No intervention
Arm Description
Outcomes
Primary Outcome Measures
Estimated fetal weight
Secondary Outcome Measures
Birth weight
Changes in Doppler blood flow indices in umbilical artery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03038607
Brief Title
Aspirin in Asymmetrically Intrauterine Growth
Official Title
Effect of Low-dose Aspirin on Fetal Weight of Idiopathic Asymmetrically Intrauterine Growth Restricted Fetuses With Abnormal Umbilical Doppler Indices
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Intrauterine growth restriction refers to a fetus that has failed to get a specific measures by a gestational age. Asymmetric type of Intrauterine growth restriction is known by normal sized head with smaller abdomen.It is important to recognize the growth restricted fetuses, because these fetuses may have fetal or neonatal complications.
When blood flow is increased, the oxygen and nutrients will deliver good to the fetus. The role of low-dose aspirin therapy in management of intrauterine growth restriction is controversial. It has been used, in many studies, in prevention of intrauterine growth restriction especially in women at high risk of pre-eclampsia or obstetrical antiphospholipid syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Growth Restriction Asymmetrical
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aspirin group
Arm Type
Active Comparator
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
This group were subjected to aspirin 75 mg once daily for 6 weeks.
Primary Outcome Measure Information:
Title
Estimated fetal weight
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Birth weight
Time Frame
6 weeks
Title
Changes in Doppler blood flow indices in umbilical artery
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The pregnant women
28-30 weeks
Idiopathic asymmetrically intrauterine growth restriction
Middle aged women (20-35 years)
Women with abnormal umbilical artery Doppler flow indices ( > +2 standard deviation above mean for gestational age)
Exclusion Criteria:
Women less than 20 and more than 35 years
hypertensive or diabetic women
any type of smoking
multiple pregnancies
amniotic fluid index <5 cm
premature pre-labor rupture of membranes
abnormal placenta
any fetal congenital malformations.
women had absent diastolic flow or reversed flow in umbilical artery at the time of recruitment.
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Aspirin in Asymmetrically Intrauterine Growth
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