Aspirin in Asymmetrically Intrauterine Growth

NCT ID: NCT03038607

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intrauterine Growth Restriction Asymmetrical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aspirin group

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

This group were subjected to aspirin 75 mg once daily for 6 weeks.

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aspirin

This group were subjected to aspirin 75 mg once daily for 6 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Khairy Ali

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Women Health Hospital - Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ASP

Identifier Type: -

Identifier Source: org_study_id