The CHIPS Trial (Control of Hypertension In Pregnancy Study)
- Conditions
- Gestational Hypertension
- Interventions
- Procedure: Intervention is blood pressure management approach.Procedure: Intervention is blood pressure management approach
- Registration Number
- NCT01192412
- Lead Sponsor
- University of British Columbia
- Brief 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.
- Detailed Description
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:
1. Increase (or decrease) the likelihood of serious perinatal complications?
2. Increase (or decrease) the likelihood of severe hypertension and pre-eclampsia?
3. Increase (or decrease) the likelihood of maternal satisfaction with care?
4. Result in significant changes in dBP or health care costs?
Treatment Allocation:
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).
Outcomes:
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.
Follow-up:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 987
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 'Tight' control. Intervention is blood pressure management approach. The diastolic blood pressure (dBP) treatment goal is 85 mmHg. 'Less tight' control. Intervention is blood pressure management approach The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
- Primary Outcome Measures
Name Time Method Pregnancy Loss or NICU Admission for Greater Than 48 Hours 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.
- Secondary Outcome Measures
Name Time Method Serious Maternal Complications Measured up to 6 Weeks Postpartum 6 weeks Serious maternal complications measured up to 6 weeks postpartum. Death or one or more life-threatening maternal complications:
1. Adverse neurological complications (stroke, eclampsia, and/or blindness), and/or
2. End-organ failure (uncontrolled hypertension, inotropic support, pulmonary oedema, respiratory failure, myocardial ischaemia/infarction, renal failure, coagulopathy, and/or transfusion)
Trial Locations
- Locations (111)
Hospital LC Lagomaggiore
🇦🇷Mendoza, Argentina
Meriter Hospital
🇺🇸Madison, Wisconsin, United States
Ottawa Hospital General Division
🇨🇦Ottawa, Ontario, Canada
Hospital Avellaneda
🇦🇷Tucuman, Argentina
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Hospital Universitario Antonio Pedro
🇧🇷Niteroi, Brazil
St John of God Hospital
🇦🇺Subiaco, Australia
Hopital Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Clinica Perinatal Barra
🇧🇷Rio de Janerio, Brazil
Women's and Children's Hospital
🇦🇺Adelaide, Australia
Ipswich Hospital
🇦🇺Ipswich, Australia
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
OLVG
🇳🇱Amsterdam, Netherlands
MUMC Maastricht
🇳🇱Maastricht, Netherlands
University School of Medical Sciences
🇵🇱Poznan, Poland
Ottawa Hospital Civic Division
🇨🇦Ottawa, Ontario, Canada
King Edward Memorial Hospital
🇦🇺Subiaco, Australia
Christchurch Women's Hospital
🇳🇿Christchurch, New Zealand
University of Debrecen
🇭🇺Debrecen, Hungary
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Kennemer Gasthuis Haarlem
🇳🇱Haarlem, Netherlands
Waitemata Health-North Shore Hospital
🇳🇿Auckland, New Zealand
Birmingham Women's Hospital
🇬🇧Birmingham, United Kingdom
Royal Lancaster Infirmary
🇬🇧Lancaster, United Kingdom
South Warwickshire NHS Trust
🇬🇧Warwickshire, United Kingdom
Hospital Materno Infantil
🇧🇷Goiania, Brazil
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Corporacion Conmfenalco Valle - Universidad Libre
🇨🇴Cali, Colombia
Jeroen Bosch Hospital
🇳🇱's-Hertogenbosch, Netherlands
Tergooiziekenhuizen
🇳🇱Hilversum, Netherlands
Medical University of Gdansk
🇵🇱Gdansk, Poland
Basildon & Thurrock University Hospital
🇬🇧Basildon, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
🇬🇧Lancashire, United Kingdom
St Mary's Hospital
🇬🇧Manchester, United Kingdom
Wexham Park Hospital
🇬🇧Slough, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Beth Israel Deaconess
🇺🇸Boston, Massachusetts, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Campbelltown Hospital
🇦🇺Campbelltown, New South Wales, Australia
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
St Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Calgary Health Region - Foothills Hospital
🇨🇦Calgary, Alberta, Canada
Hospital Dr Sotero del Rio
🇨🇱Puente Alto, Chile
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
East Carolina University
🇺🇸Greenville, North Carolina, United States
CHUS Fleurimont
🇨🇦Sherbrooke, Quebec, Canada
Hospital Base Osorno
🇨🇱Osorno, Chile
Jim Pattison Outpatient Care and Surgery Centre
🇨🇦Surrey, British Columbia, Canada
Ma'ayney Hayeshua Medical Center
🇮🇱Bnei Brak, Israel
Islamic Hospital
🇯🇴Amman, Jordan
Hospital JM Cullen
🇦🇷Santa Fe, Argentina
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Meander Medisch Centrum
🇳🇱Amersfoort, Netherlands
St Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
University of British Columbia, Department of Obstetrics & Gynaecology
🇨🇦Vancouver, British Columbia, Canada
Isala Klinieken Zwolle
🇳🇱Zwolle, Netherlands
Polish Mothers Memorial Hospital
🇵🇱Lodz, Poland
Children's & Women's Health Centre of BC
🇨🇦Vancouver, British Columbia, Canada
Hospital JR Vidal
🇦🇷Corrientes, Argentina
Spaarne Ziekenhuis
🇳🇱Hoofddorp, Netherlands
Ziekenhuis Bernhoven
🇳🇱Oss, Netherlands
UMCU
🇳🇱Utrecht, Netherlands
St Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Women's Health Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
Clinica Materno Infantil Farallones
🇨🇴Cali, Colombia
Clinica Versalles
🇨🇴Cali, Colombia
Tartu University Hospital-Women's Clinic
🇪🇪Tartu, Estonia
VU Medical Center
🇳🇱Amsterdam, Netherlands
Hillel Yaffe Medical Center
🇮🇱Hadera, Israel
Nazareth Hospital (EMMS)
🇮🇱Nazareth, Israel
Flevo ziekenhuis
🇳🇱Almere, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
UMCG
🇳🇱Groningen, Netherlands
Diakonessen Ziekenhuis
🇳🇱Utrecht, Netherlands
Maxima Medical Centre
🇳🇱Veldhoven, Netherlands
East Lancashire Hospitals NHS Trust
🇬🇧Blackburn, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Chesterfield Royal Hospital
🇬🇧Chesterfield, United Kingdom
University Hospital Coventry and Warwickshire
🇬🇧Coventry, United Kingdom
The Royal Derby Hospital
🇬🇧Derby, United Kingdom
Calderdale Royal Hospital
🇬🇧Halifax, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Liverpool Women's Hospital
🇬🇧Liverpool, United Kingdom
Guy's & St Thomas' Hospital
🇬🇧London, United Kingdom
Queen Elizabeth Hospital
🇬🇧London, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle upon Tyne, United Kingdom
King's Mill Hospital
🇬🇧Nottinghamshire, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, United Kingdom
Southport & Ormskirk Hospital
🇬🇧Ormskirk, United Kingdom
City Hospitals Sunderland NHS Foundation Trust
🇬🇧Sunderland, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
Singleton Hospital
🇬🇧Swansea, United Kingdom
York District Hospital
🇬🇧York, United Kingdom
Hospital Sao Lucas - PUCRS
🇧🇷Porto Alegre, Brazil
Maternidade Escola de Vila Nova Cachoeirinha
🇧🇷Sao Paulo, Brazil
Maternidade Escola da UFRJ
🇧🇷Rio de Janeiro, Brazil
Laranjeiras Clinica Perinatal
🇧🇷Rio de Janerio, Brazil
Regina General Hospital
🇨🇦Regina, Canada
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Norton Suburban Hospital
🇺🇸Louisville, Kentucky, United States
Norton Hospital Downtown
🇺🇸Louisville, Kentucky, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada