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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03038607
Other study ID # ASP
Secondary ID
Status Completed
Phase Phase 2
First received January 29, 2017
Last updated January 29, 2017
Start date January 2016
Est. completion date January 2017

Study information

Verified date January 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Women Health Hospital - Assiut university Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Estimated fetal weight 6 weeks
Secondary Birth weight 6 weeks
Secondary Changes in Doppler blood flow indices in umbilical artery 6 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT03321292 - L-arginine in Treatment of Intrauterine Growth Restriction N/A