The CHIPS trial: Control of Hypertension In Pregnancy Study

Not Applicable

Completed

• Conditions: on-proteinuric pre-existing or gestational hypertension in pregnancy; Pregnancy and Childbirth; Gestational [pregnancy-induced] hypertension with significant proteinuria

• Registration Number: ISRCTN71416914
• Lead Sponsor: niversity of British Columbia (Canada)

Brief Summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25629739 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25787408 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25787355 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26259808 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26265372 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27620393 2018 secondary analysis in: https://www.ncbi.nlm.nih.gov/pubmed/29686009

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-31
• Study Completion: 2014-03-31
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1028

Inclusion Criteria

1. Pre-existing or gestational hypertension (pre-existing hypertension is dBP greater than or equal to 90 mmHg before pregnancy or 20 weeks' gestation; gestational hypertension is dBP greater than or equal to 90 mmHg that develops after 20 weeks)
2. dBP of 90 - 105 mmHg if NOT TAKING antihypertensive therapy, or dBP of 85 - 105 mmHg if TAKING antihypertensive therapy
3. Live foetus (confirmed by Doptone assessment of foetal heart tones within one week before randomisation)
4. Gestational age 14 - 33+6 weeks (as measured by last menstrual period or dating ultrasound)

Exclusion Criteria

Amendments as of 15/03/2010:
Please note that as of the above date, this record has been updated to include a protocol amendment (approved 17/03/2009) to point 3 of the exclusion criteria below. This should now read as follows:
3. Use of an angiotensin converting enzyme (ACE) inhibitor at greater than or equal to 14+0 weeks' gestation

Initial exclusion criteria at time of registration:
1. Severe systolic hypertension (defined as a systolic blood pressure [sBP] greater than or equal to 160 mmHg at randomisation)
2. Proteinuria (defined as greater than or equal to 0.3 g/d by 24 hour urine collection, or if a 24 hour urine collection is not available, by a urinary protein:creatinine ratio of greater than or equal to 30 mg/mmol or urinary dipstick of greater than or equal to 2+)
3. Use of an angiotensin converting enzyme (ACE) inhibitor at any time in the pregnancy
4. Contraindication to either arm of the trial or to pregnancy prolongation
5. Known multiple gestation
6. Known lethal or major foetal anomaly
7. Plan to terminate pregnancy
8. Prior participation in CHIPS

Study & Design

• Study Type: Interventional
• Study Design: Not specified