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Low-dose aspirin for preventing intrauterine growth restriction and pre-eclampsia in sickle cell pregnancy
Bosede Bukola Afolabi1, Ochuwa Adiketu Babah2, Titilope Adenike Adeyemo3
1Obstetrics and Gynaecology, University of Lagos College of Medicine, Idi-Araba, Lagos, Nigeria bbafolabi@unilag.edu.ng.
Insights
Low-dose aspirin (LDA) may reduce pregnancy complications like pre-eclampsia and intrauterine growth restriction in women with sickle cell disease. This study investigates LDA
Area of Science:
- Obstetrics and Gynecology
- Hematology
- Clinical Trials
Background:
- Pregnancy in sickle cell disease (SCD) is associated with high rates of pre-eclampsia (PE) and intrauterine growth restriction (IUGR).
- An abnormal prostacyclin-thromboxane ratio, implicated in PE and IUGR, is observed in SCD pregnancies.
- Low-dose aspirin (LDA) is known to correct this ratio and is safe in typical pregnancies, but its efficacy in SCD pregnancy is unproven.
Purpose of the Study:
- To investigate the efficacy of LDA in reducing the incidence of IUGR and PE in pregnant women with hemoglobin SS (HbSS) and hemoglobin SC (HbSC) disease.
- To evaluate the safety and effectiveness of LDA in a high-risk obstetric population.
Main Methods:
- A multisite, double-blind, randomized controlled trial comparing daily 100mg LDA to placebo.
- Recruitment of 476 pregnant women with HbSS or HbSC in Lagos, Nigeria, from 12-16 weeks gestation until 36 weeks.
- Primary outcome: incidence of birth weight below the 10th percentile, miscarriage, or perinatal death. Secondary outcomes include PE, maternal death, and other complications.
Main Results:
- This section is for pre-results; specific findings are not yet available.
- The study is registered and ongoing, with data collection and analysis planned.
Conclusions:
- The study hypothesizes that LDA will decrease IUGR and PE in pregnant women with HbSS and HbSC.
- Findings will provide crucial evidence on LDA's role in managing SCD pregnancy complications.
Introduction:
Pregnancy in sickle cell disease is fraught with many complications including pre-eclampsia (PE) and intrauterine growth restriction (IUGR). Previously, we found an abnormality in prostacyclin-thromboxane ratio in sickle cell pregnant women, a situation that is also found in non-sickle pregnancies with PE and unexplained IUGR. Low-dose aspirin (LDA) has been shown to reduce the incidence of PE and IUGR in high-risk women by reducing the vasoconstrictor thromboxane while sparing prostacyclin, in effect 'correcting' the ratio. It has been found to be safe for use in pregnancy but has not been tested in sickle cell pregnancy. We hypothesise that LDA will reduce the incidence of IUGR and PE in pregnant haemoglobin SS (HbSS) and haemoglobin SC (HbSC) women.
Methods And Analysis:
This is a multisite, double blind, randomised controlled trial, comparing a daily dose of 100 mg aspirin to placebo, from 12 to 16 weeks' gestation until 36 weeks, in Lagos state, Nigeria. Four hundred and seventy-six eligible pregnant HbSS and HbSC women will be recruited consecutively, randomly assigned to either group and followed from recruitment until delivery. The primary outcome will be the incidence of birth weight below 10th centile for gestational age on INTERGROWTH 21 birth weight charts, or incidence of miscarriage or perinatal death. Secondary outcomes will include PE, maternal death, preterm delivery, perinatal death, number of crises, need for blood transfusion and complications such as infections and placental abruption. Analysis will be by intention to treat and the main treatment effects will be quantified by relative risk with 95% CI, at a 5% significance level.
Ethical Approval:
Ethical approval has been granted by the Health Research and Ethics committees of the recruiting hospitals and the National Health Research and Ethics Committee. Study findings will be presented at conferences and published appropriately.
Trail Registration Number:
PACTR202001787519553; Pre-results.
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