OPTIMUM: Optimising titration and monitoring of maternal blood pressure

Not Applicable

Completed

• Conditions: Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive health and childbirth (migration); Pregnancy and Childbirth; Chronic hypertension in pregnancy

• Registration Number: ISRCTN16018898
• Lead Sponsor: niversity of Oxford Clinical Trials and Research Governance Team

Brief Summary

2019 Results article in https://doi.org/10.1016/j.preghy.2019.09.018 results (added 16/10/2019) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34082300/ Secondary analysis (added 18/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-04
• Study Completion: 2018-10-31
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 158

Inclusion Criteria

1. Women with chronic hypertension (defined as sustained diastolic BP=90 mmHg and/or systolic BP=140 mmHg, present at booking or before 20 weeks gestation, or receiving treatment outside pregnancy and/or at time of referral)
2. Recruited at booking­ 23+6 weeks gestation
3. Viable singleton pregnancy
4. Willing to be randomised
5. Able to give informed written consent
6. Aged 18 years and over

Exclusion Criteria

1. Unwilling to self­monitor
2. Insufficient understanding of the study
3. Confirmed super­imposed pre­eclampsia (as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP) 2014 statement) before recruitment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Recruitment rate is determined at the end of the study period by recording the number of participants recruited per site per month, including as proportion of those who were approached and eligible<br>2. Loss to follow up is determined at the end of the study period by recording the number lost to follow-up after delivery/number of participants recruited<br>3. Withdrawal rate is determined at the end of the study period by recording the number of participants withdrawing consent/number of participants recruited<br>4. Adherence and persistence with BP self-monitoring protocol is determined as the proportion of intervention participants completing no home BP measurements (total and by week) at the end of the study period<br>5. Acceptability of randomisation is determined at the end of the study period by recoridng the proportion of participants citing randomisation as reason for non-participation and the proportion in usual care arm starting home BP monitoring post-randomisation