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Completed

NCT Number: NCT03038607

Aspirin in Asymmetrically Intrauterine Growth

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.

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Key information

Conditions

Intrauterine Growth Restriction Asymmetrical

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin

Drug

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

Primary outcomes

  1. Estimated fetal weight

    Time frame: 6 weeks

Secondary outcomes

  1. Birth weight

    Time frame: 6 weeks

  2. Changes in Doppler blood flow indices in umbilical artery

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Low-dose Aspirin on Fetal Weight of Idiopathic Asymmetrically Intrauterine Growth Restricted Fetuses With Abnormal Umbilical Doppler Indices

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 31, 2017
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.