N/A
N=987
The CHIPS Trial (Control of Hypertension In Pregnancy Study)
Gestational Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01192412 ↗Enrolled (actual)
987
Serious AEs
31.1%
Results posted
Jan 2017
Primary outcome: Primary: Pregnancy Loss or NICU Admission for Greater Than 48 Hours — 155; 150 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention is blood pressure management approach (Procedure); Intervention is blood pressure management approach. (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- University of British Columbia
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pregnancy Loss or NICU Admission for Greater Than 48 Hours |
155; 150 | — |
| SECONDARY Serious Maternal Complications Measured up to 6 Weeks Postpartum |
18; 10 | — |
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.
Eligibility Criteria
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
- Prior participation in CHIPS
Data sourced from ClinicalTrials.gov (NCT01192412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.