ow dose aspirin for preventing intrauterine growth restriction and preeclampsia in sickle cell pregnancy (PIP-SICKLE): a randomised controlled trial.

Not Applicable

Recruiting

• Conditions: Genetic Diseases; Haematological Disorders; Pregnancy and Childbirth; Intrauterine growth restriction, preeclampsia

• Registration Number: PACTR202001787519553
• Lead Sponsor: TETFUND

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 476

Inclusion Criteria

Age 18 years and above
Singleton fetus
Women with sickle cell anaemia i.e. Haemoglobin SS.
16 weeks gestation or less at recruitment, confirmed by an ultrasound scan or certain last menstrual period dates

Exclusion Criteria

Other sickle cell disease variants eg Hb SC
Women with associated medical conditions in pregnancy eg HIV infection, diabetes mellitus, chronic hypertension, renal disease, sickle nephropathy
Women with multiple pregnancy
Hypersensitivity to aspirin
History of vaso-occlusive crisis in the last 4 weeks
History of blood transfusion in the last 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intrauterine growth restriction, birth weight below the 10th centile for gestational age on INTERGROWTH 21 birthweight charts, or stillbirth, or fetal death or miscarriage

Secondary Outcome Measures

Name	Time	Method
preeclampsia;maternal death, preterm delivery, number of crises, need for blood transfusion;Complications such as <br>- Urinary tract infection<br>- Lower Respiratory tract infection<br>- Acute chest syndrome<br>- Retained placenta<br>- Placental abruption<br>;Potential adverse effects such as<br>- Vaginal bleeding<br>- Epigastric pain<br>- Heartburn<br>