The CHIPS Trial (Control of Hypertension In Pregnancy Study) (NCT01192412) | Clinical Trial Compass
CompletedNot Applicable
The CHIPS Trial (Control of Hypertension In Pregnancy Study)
United States987 participantsStarted 2009-04
Plain-language summary
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.
Who can participate
SexFEMALE
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Inclusion criteria
✓. 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)
Exclusion criteria
✕. 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
What they're measuring
1
Pregnancy Loss or NICU Admission for Greater Than 48 Hours