Aspirin in Asymmetrically Intrauterine Growth

Assiut University

Status and phase: Completed; Phase 2

Conditions: Intrauterine Growth Restriction Asymmetrical

Treatments: Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT03038607

ASP

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Aspirin group

Active Comparator group

Treatment:

Drug: Aspirin

No intervention

No Intervention group