The CHIPS Trial (Control of Hypertension In Pregnancy Study)
|ClinicalTrials.gov Identifier: NCT01192412|
Recruitment Status : Completed
First Posted : September 1, 2010
Results First Posted : January 11, 2017
Last Update Posted : January 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Gestational Hypertension||Procedure: Intervention is blood pressure management approach Procedure: Intervention is blood pressure management approach.||Not Applicable|
Primary research question:
For pregnant women with non-severe, non-proteinuric maternal hypertension at 14-33 weeks, will 'less tight' control (target diastolic blood pressure [dBP] of 100 mmHg) versus 'tight' control (target dBP of 85 mmHg) increase (or decrease) the likelihood of pregnancy loss or Neonatal Intensive Care Unit (NICU) admission for greater than 48 hours?
Secondary research question:
Will 'less tight' versus 'tight' control increase (or decrease) the likelihood of serious maternal complications?
Other research questions:
Will 'less tight' versus 'tight' control:
- Increase (or decrease) the likelihood of serious perinatal complications?
- Increase (or decrease) the likelihood of severe hypertension and pre-eclampsia?
- Increase (or decrease) the likelihood of maternal satisfaction with care?
- Result in significant changes in dBP or health care costs?
Eligible women will be randomised centrally to either 'less tight' control (aiming for dBP of 100mmHg) or 'tight' control (aiming for dBP of 85mmHg) of their hypertension.
Randomisation will be stratified by centre and type of hypertension (pre-existing or gestational).
- In the 'less tight' control group, if dBP is ≥105mmHg, then antihypertensive medication must be started or increased in dose.
- In the 'tight' control group, if dBP is ≤80mmHg, then antihypertensive medication must be decreased in dose or discontinued.
- In both groups, centres will provide their usual care. Data will be collected on potential co-interventions (e.g., hospitalisation, bedrest).
Primary: Pregnancy loss (miscarriage or ectopic pregnancy, pregnancy termination, stillbirth, or neonatal death) or high level neonatal care for >48 hours in the first 28 days of life or prior to primary hospital discharge, whichever is later.
Secondary: One/more serious maternal complication(s) until six weeks postpartum.
Compliance (dBP and antihypertensive dose) will be assessed within 4 weeks of randomisation. Outcome data will be collected during the woman's (and baby's) hospital stay for birth (or loss). Women will be contacted 6 to 12 weeks after delivery (or loss) and, for preterm babies, when the baby is at 36 weeks corrected gestational age to enquire about satisfaction with care and any major maternal/neonatal morbidity following hospital discharge.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||987 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The CHIPS Trial (Control of Hypertension In Pregnancy Study)|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Active Comparator: 'Less tight' control.
The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
Procedure: Intervention is blood pressure management approach
1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery.
Active Comparator: 'Tight' control.
The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
Procedure: Intervention is blood pressure management approach.
'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery.
- Pregnancy Loss or NICU Admission for Greater Than 48 Hours [ Time Frame: 6 weeks ]Pregnancy loss or NICU admission for greater than 48 hours, as recorded in the maternal and infant medical records immediately following the birth (or pregnancy loss), and then again after the mothers' and infants' discharge home. Supplemental information, about potential post-discharge maternal or neonatal morbidities in the 6 weeks following birth for the mother, or 28 days of life for the baby, will be obtained by contacting women at 6 weeks postpartum and/or from medical records.
- Serious Maternal Complications Measured up to 6 Weeks Postpartum [ Time Frame: 6 weeks ]
Serious maternal complications measured up to 6 weeks postpartum. Death or one or more life-threatening maternal complications:
- Adverse neurological complications (stroke, eclampsia, and/or blindness), and/or
- End-organ failure (uncontrolled hypertension, inotropic support, pulmonary oedema, respiratory failure, myocardial ischaemia/infarction, renal failure, coagulopathy, and/or transfusion)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192412
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|Principal Investigator:||Laura A Magee, MD, FRCPC, MSc, FACP||The University of British Columbia|