Aspirin in Asymmetrically Intrauterine Growth

NCT03038607 | Completed Phase 2

• 1 other identifier: ASP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Growth Restriction Asymmetrical

Outcome Measures

Primary Outcomes (1)

• Estimated fetal weight

  6 weeks

Secondary Outcomes (2)

• Birth weight

  6 weeks

• Changes in Doppler blood flow indices in umbilical artery

  6 weeks

Study Arms (2)

Aspirin group

ACTIVE COMPARATOR

Drug: Aspirin

No intervention

NO INTERVENTION

Interventions

Aspirin DRUG

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

Aspirin group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The pregnant women
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 29, 2017
• First Posted: January 31, 2017
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 31, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)