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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01192412
Other study ID # H08-00882
Secondary ID MCT-8752207-3431
Status Completed
Phase N/A
First received August 30, 2010
Last updated February 4, 2015
Start date April 2009
Est. completion date February 2014

Study information

Verified date February 2015
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT01081171

Recruitment information / eligibility

Status Completed
Enrollment 987
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

1. 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)

2. dBP of 90 - 105 mmHg if NOT TAKING antihypertensive therapy, or dBP of 85 - 105 mmHg if TAKING antihypertensive therapy

3. Live foetus (confirmed by Doptone assessment of foetal heart tones within one week before randomisation)

4. Gestational age 14 - 33+6 weeks (as measured by last menstrual period or dating ultrasound)

Exclusion Criteria:

1. Severe systolic hypertension (defined as a systolic blood pressure [sBP] greater than or equal to 160 mmHg at randomisation)

2. 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+)

3. Use of an angiotensin converting enzyme (ACE) inhibitor at greater than or equal to 14+0 weeks' gestation

4. Contraindication to either arm of the trial or to pregnancy prolongation

5. Known multiple gestation

6. Known lethal or major foetal anomaly

7. Plan to terminate pregnancy

8. Prior participation in CHIPS

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.
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.

Locations

Country Name City State
Argentina Hospital JR Vidal Corrientes
Argentina Hospital LC Lagomaggiore Mendoza
Argentina Hospital JM Cullen Santa Fe
Argentina Hospital Avellaneda Tucuman
Australia Women's and Children's Hospital Adelaide
Australia Campbelltown Hospital Campbelltown New South Wales
Australia Ipswich Hospital Ipswich
Australia Liverpool Hospital Liverpool New South Wales
Australia King Edward Memorial Hospital Subiaco
Australia St John of God Hospital Subiaco
Brazil Hospital Materno Infantil Goiania
Brazil Hospital Universitario Antonio Pedro Niteroi
Brazil Hospital Sao Lucas - PUCRS Porto Alegre
Brazil Maternidade Escola da UFRJ Rio de Janeiro
Brazil Clinica Perinatal Barra Rio de Janerio
Brazil Laranjeiras Clinica Perinatal Rio de Janerio
Brazil Maternidade Escola de Vila Nova Cachoeirinha Sao Paulo
Canada Calgary Health Region - Foothills Hospital Calgary Alberta
Canada Royal Alexandra Hospital Edmonton Alberta
Canada IWK Health Centre Halifax Nova Scotia
Canada London Health Sciences Centre London Ontario
Canada Hopital Sainte-Justine Montreal Quebec
Canada Royal Victoria Hospital Montreal Quebec
Canada Ottawa Hospital Civic Division Ottawa Ontario
Canada Ottawa Hospital General Division Ottawa Ontario
Canada Regina General Hospital Regina
Canada Royal University Hospital Saskatoon Saskatchewan
Canada CHUS Fleurimont Sherbrooke Quebec
Canada Women's Health Centre St. John's Newfoundland and Labrador
Canada Jim Pattison Outpatient Care and Surgery Centre Surrey British Columbia
Canada 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 Children's & Women's Health Centre of BC Vancouver British Columbia
Canada St Paul's Hospital Vancouver British Columbia
Canada University of British Columbia, Department of Obstetrics & Gynaecology Vancouver British Columbia
Canada St Boniface General Hospital Winnipeg Manitoba
Chile Hospital Base Osorno Osorno
Chile Hospital Dr Sotero del Rio Puente Alto
Colombia Clinica Materno Infantil Farallones Cali
Colombia Clinica Versalles Cali
Colombia Corporacion Conmfenalco Valle - Universidad Libre Cali
Estonia Tartu University Hospital-Women's Clinic Tartu
Hungary University of Debrecen Debrecen
Israel Ma'ayney Hayeshua Medical Center Bnei Brak
Israel Hillel Yaffe Medical Center Hadera
Israel Nazareth Hospital (EMMS) Nazareth
Jordan Islamic Hospital Amman
Netherlands Jeroen Bosch Hospital 's-Hertogenbosch
Netherlands Flevo ziekenhuis Almere
Netherlands Meander Medisch Centrum Amersfoort
Netherlands Academic Medical Center Amsterdam
Netherlands OLVG Amsterdam
Netherlands VU Medical Center Amsterdam
Netherlands Medisch Spectrum Twente Enschede
Netherlands UMCG Groningen
Netherlands Kennemer Gasthuis Haarlem Haarlem
Netherlands Tergooiziekenhuizen Hilversum
Netherlands Spaarne Ziekenhuis Hoofddorp
Netherlands MUMC Maastricht Maastricht
Netherlands St Antonius Ziekenhuis Nieuwegein
Netherlands Ziekenhuis Bernhoven Oss
Netherlands Diakonessen Ziekenhuis Utrecht
Netherlands UMCU Utrecht
Netherlands Maxima Medical Centre Veldhoven
Netherlands Isala Klinieken Zwolle Zwolle
New Zealand Waitemata Health-North Shore Hospital Auckland
New Zealand Christchurch Women's Hospital Christchurch
Poland Medical University of Gdansk Gdansk
Poland Polish Mothers Memorial Hospital Lodz
Poland University School of Medical Sciences Poznan
United Kingdom Basildon & Thurrock University Hospital Basildon
United Kingdom Birmingham Women's Hospital Birmingham
United Kingdom 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 Lancashire Teaching Hospitals NHS Foundation Trust Lancashire
United Kingdom Royal Lancaster Infirmary Lancaster
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 St Mary's Hospital Manchester
United Kingdom Royal Victoria Infirmary Newcastle upon Tyne
United Kingdom Nottingham City Hospital Nottingham
United Kingdom Queen's Medical Centre Nottingham
United Kingdom King's Mill Hospital Nottinghamshire
United Kingdom Southport & Ormskirk Hospital Ormskirk
United Kingdom Derriford Hospital Plymouth
United Kingdom Sheffield Teaching Hospitals NHS Foundation Trust Sheffield
United Kingdom Wexham Park Hospital Slough
United Kingdom City Hospitals Sunderland NHS Foundation Trust Sunderland
United Kingdom Singleton Hospital Swansea
United Kingdom South Warwickshire NHS Trust Warwickshire
United Kingdom New Cross Hospital Wolverhampton
United Kingdom York District Hospital York
United States Beth Israel Deaconess Boston Massachusetts
United States Cooper University Hospital Camden New Jersey
United States University of North Carolina Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States East Carolina University Greenville North Carolina
United States Norton Hospital Downtown Louisville Kentucky
United States Norton Suburban Hospital Louisville Kentucky
United States Meriter Hospital Madison Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States Yale-New Haven Hospital New Haven Connecticut
United States Oregon Health and Science University Portland Oregon

Sponsors (3)

Lead Sponsor Collaborator
University of British Columbia Canadian Institutes of Health Research (CIHR), Sunnybrook Research Institute

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Chile,  Colombia,  Estonia,  Hungary,  Israel,  Jordan,  Netherlands,  New Zealand,  Poland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pregnancy loss or NICU admission for greater than 48 hours 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. 6 weeks Yes
Secondary Serious maternal complications measured up to 6 weeks postpartum 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)
6 weeks Yes
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