The CHIPS Trial (Control of Hypertension In Pregnancy Study)
Completed · Not applicable
Conditions studied: Gestational Hypertension
In brief
The investigators do not know which approach to treatment of non-severe high blood pressure in pregnancy is better for women and babies. In the CHIPS Trial, the investigators seek to determine whether 'less tight' control (aiming for a diastolic blood pressure \[dBP\] of 100 mmHg), compared with 'tight' control (aiming for a diastolic blood pressure \[dBP\] of 85 mmHg) can decrease the risks of adverse baby outcomes without increasing the risk of problems for the mother.
Key facts
- Study ID
- NCT01192412
- Run by
- University of British Columbia
- People needed
- 987
- Starts
- 2009-04-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2017-01-11
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- dBP of 90 - 105 mmHg if NOT TAKING antihypertensive therapy, or dBP of 85 - 105 mmHg if TAKING antihypertensive therapy
- Live foetus (confirmed by Doptone assessment of foetal heart tones within one week before randomisation)
- Gestational age 14 - 33+6 weeks (as measured by last menstrual period or dating ultrasound)
You may not qualify if…
- Severe systolic hypertension (defined as a systolic blood pressure [sBP] greater than or equal to 160 mmHg at randomisation)
- 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+)
- Use of an angiotensin converting enzyme (ACE) inhibitor at greater than or equal to 14+0 weeks' gestation
- Contraindication to either arm of the trial or to pregnancy prolongation
- Known multiple gestation
- Known lethal or major foetal anomaly
- Plan to terminate pregnancy
- Prior participation in CHIPS
Where it is running
- Norton Hospital Downtown — Louisville, Kentucky, United States
- Norton Suburban Hospital — Louisville, Kentucky, United States
- Beth Israel Deaconess — Boston, Massachusetts, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Cooper University Hospital — Camden, New Jersey, United States
- University of North Carolina — Chapel Hill, North Carolina, United States
- East Carolina University — Greenville, North Carolina, United States
- Oregon Health and Science University — Portland, Oregon, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Meriter Hospital — Madison, Wisconsin, United States
- Hospital JR Vidal — Corrientes, Argentina
- Hospital LC Lagomaggiore — Mendoza, Argentina
- Hospital Avellaneda — San Miguel de Tucumán, Argentina
- Hospital JM Cullen — Santa Fe, Argentina
- Campbelltown Hospital — Campbelltown, New South Wales, Australia
- Liverpool Hospital — Liverpool, New South Wales, Australia
- Women's and Children's Hospital — Adelaide, Australia
- Ipswich Hospital — Ipswich, Australia
- King Edward Memorial Hospital — Subiaco, Australia
- St John of God Hospital — Subiaco, Australia
- Hospital Materno Infantil — Goiânia, Brazil
- Hospital Universitario Antonio Pedro — Niterói, Brazil
- Hospital Sao Lucas - PUCRS — Porto Alegre, Brazil
- Maternidade Escola da UFRJ — Rio de Janeiro, Brazil
- Yale-New Haven Hospital — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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