Calcium and Aspirin Supplementation for Prevention of Preeclampsia (in High Risk Pregnancy)

Phase 3

• Conditions: Pregnant women with one or more high risk and women with two or more moderate risk of developing preeclampsia; calcium carbonate; pre-eclampsia; prevention

• Registration Number: TCTR20221001001
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-04-05
• Study Start: 2022-10-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Terminated (Halted Prematurely)
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

Those who have one or more high-risk or two or more moderate risks of developing pre-eclampsia High risk of developing pre-eclampsia was defined as a pregnant woman with multifetal gestation, chronic hypertension, type 1 or type 2 diabetes, renal disease, autoimmune disease (e.g., systemic lupus erythematosus and antiphospholipid syndrome), and a history of pre-eclampsia. Moderate risk was defined as women with nulliparity, obesity with body mass index more than 30 kg/m2, family history of pre-eclampsia, age 35 years or older, personal history factors (e.g., low birthweight or small for gestational age, previous adverse pregnancy outcome, more than 10-year pregnancy interval)

Exclusion Criteria

Exclusion criteria were patients with a history of kidney or ureteric stone, parathyroid disorders, untreated nasal polyp, aspirin-induced bronchospasm, gastrointestinal or urinary hemorrhage, severe liver disease, hypercalcemia (serum corrected calcium level more than 10.5 mg/dL), allergic to aspirin or CaCO3, and other underlying diseases already receiving aspirin or calcium supplementation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of pre-eclampsia with severe features Until delivery Incidence

Secondary Outcome Measures

Name	Time	Method
Incidence of pre-eclampsia without severe features Until delivery Incidence,Incidence of gestational hypertension Until delivery Incidence,Gestational age at delivery until delivery gestational age (weeks),Neonatal outcome until discharge Apgar, birthweight, NICU admission and length of stay,Adverse event until delivery constipation, nausea and vomiting, PPH