Can esomeprazole improve outcomes in women at high risk of pre-eclampsia? The ESPRESSO Study

Can esomeprazole improve outcomes in women at high risk of pre-eclampsia? A phase II placebo-controlled randomised multi-centre clinical trial. The ESPRESSO Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001755224

Acronym

ESPRESSO

Enrollment

359

Registered

2018-10-25

Start date

2019-04-18

Completion date

2024-12-16

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The risk of pre-eclampsia (elevated blood pressure in pregnancy) can be predicted through a screening test at 11-13+6 weeks' gestation. Previous work has shown that 'high risk' women benefit from taking aspirin through their pregnancy - resulting in a 62% reduction in pre-eclampsia prevalence before 37 weeks. Current treatment does not alter the prevalence of term pre-eclampsia (i.e. after 37 weeks). This study will test whether adding another treatment (esomeprazole) will cause a further reduction in blood pressure at the end of pregnancy. Pregnant women will take one esomeprazole or placebo tablet each day from before 16 weeks until delivery, in addition to aspirin, and will have their blood pressure measured throughout the study.

Interventions

Esomeprazole 40mg oral tablet at night commencing prior to 16 weeks gestation and continuing until delivery of pregnancy. Required background therapy is aspirin 150mg oral tablet at night commencing prior to 16 weeks gestation and continuing until 36 weeks gestation. Participants will be questioned on compliance at each visit, and a tablet count performed at 28 and 36 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Pregnant women screened at 11+0 to 13+6 weeks gestation and at high risk (>1%) of pre-eclampsia based on the FMF algorithm. 2. Aged 18 years and older 3. Willing and able to comply with all study requirements 4. Willing and able to commence study treatment before 16+0 weeks 5. Signed, written informed consent.

Exclusion criteria

1. Gestation greater than or equal to 16+0 weeks 2. Contradindications to investigational product 3. Contraindications to aspirin 4. Use of esomeprazole for any reason 5. Intention to terminate pregnancy

Outcome results