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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrauterine Growth Restriction Asymmetrical

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
January 29, 2017
Last Updated
January 29, 2017
Sponsor
Assiut University
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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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