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The CHIPS Trial (Control of Hypertension In Pregnancy Study)

Primary Purpose

Gestational Hypertension

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intervention is blood pressure management approach
Intervention is blood pressure management approach.
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Hypertension focused on measuring hypertension, pregnancy, antihypertensive therapy, perinatal outcome, maternal outcome, Non-severe, non-proteinuric pre-existing or gestational hypertension in pregnancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Yale-New Haven Hospital
  • Norton Hospital Downtown
  • Norton Suburban Hospital
  • Beth Israel Deaconess
  • University of Minnesota
  • Cooper University Hospital
  • University of North Carolina
  • East Carolina University
  • Oregon Health and Science University
  • Medical University of South Carolina
  • Meriter Hospital
  • Hospital JR Vidal
  • Hospital LC Lagomaggiore
  • Hospital JM Cullen
  • Hospital Avellaneda
  • Campbelltown Hospital
  • Liverpool Hospital
  • Women's and Children's Hospital
  • Ipswich Hospital
  • King Edward Memorial Hospital
  • St John of God Hospital
  • Hospital Materno Infantil
  • Hospital Universitario Antonio Pedro
  • Hospital Sao Lucas - PUCRS
  • Maternidade Escola da UFRJ
  • Clinica Perinatal Barra
  • Laranjeiras Clinica Perinatal
  • Maternidade Escola de Vila Nova Cachoeirinha
  • Calgary Health Region - Foothills Hospital
  • Royal Alexandra Hospital
  • Jim Pattison Outpatient Care and Surgery Centre
  • University of British Columbia, Department of Obstetrics & Gynaecology
  • Children's & Women's Health Centre of BC
  • St Paul's Hospital
  • St Boniface General Hospital
  • Women's Health Centre
  • IWK Health Centre
  • London Health Sciences Centre
  • Ottawa Hospital Civic Division
  • Ottawa Hospital General Division
  • Mount Sinai Hospital
  • St Michael's Hospital
  • Sunnybrook Health Sciences Centre
  • Toronto East General Hospital
  • Hopital Sainte-Justine
  • Royal Victoria Hospital
  • CHUS Fleurimont
  • Royal University Hospital
  • Regina General Hospital
  • Hospital Base Osorno
  • Hospital Dr Sotero del Rio
  • Clinica Materno Infantil Farallones
  • Clinica Versalles
  • Corporacion Conmfenalco Valle - Universidad Libre
  • Tartu University Hospital-Women's Clinic
  • University of Debrecen
  • Ma'ayney Hayeshua Medical Center
  • Hillel Yaffe Medical Center
  • Nazareth Hospital (EMMS)
  • Islamic Hospital
  • Jeroen Bosch Hospital
  • Flevo ziekenhuis
  • Meander Medisch Centrum
  • Academic Medical Center
  • OLVG
  • VU Medical Center
  • Medisch Spectrum Twente
  • UMCG
  • Kennemer Gasthuis Haarlem
  • Tergooiziekenhuizen
  • Spaarne Ziekenhuis
  • MUMC Maastricht
  • St Antonius Ziekenhuis
  • Ziekenhuis Bernhoven
  • Diakonessen Ziekenhuis
  • UMCU
  • Maxima Medical Centre
  • Isala Klinieken Zwolle
  • Waitemata Health-North Shore Hospital
  • Christchurch Women's Hospital
  • Medical University of Gdansk
  • Polish Mothers Memorial Hospital
  • University School of Medical Sciences
  • Basildon & Thurrock University Hospital
  • Birmingham Women's Hospital
  • East Lancashire Hospitals NHS Trust
  • Bradford Royal Infirmary
  • Chesterfield Royal Hospital
  • University Hospital Coventry and Warwickshire
  • The Royal Derby Hospital
  • Calderdale Royal Hospital
  • Lancashire Teaching Hospitals NHS Foundation Trust
  • Royal Lancaster Infirmary
  • Leicester Royal Infirmary
  • Liverpool Women's Hospital
  • Guy's & St Thomas' Hospital
  • Queen Elizabeth Hospital
  • St Mary's Hospital
  • Royal Victoria Infirmary
  • King's Mill Hospital
  • Nottingham City Hospital
  • Queen's Medical Centre
  • Southport & Ormskirk Hospital
  • Derriford Hospital
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • Wexham Park Hospital
  • City Hospitals Sunderland NHS Foundation Trust
  • Singleton Hospital
  • South Warwickshire NHS Trust
  • New Cross Hospital
  • York District Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

'Less tight' control.

'Tight' control.

Arm Description

The diastolic blood pressure (dBP) treatment goal is 100 mmHg.

The diastolic blood pressure (dBP) treatment goal is 85 mmHg.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
August 30, 2010
Last Updated
November 15, 2016
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Sunnybrook Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01192412
Brief Title
The CHIPS Trial (Control of Hypertension In Pregnancy Study)
Official Title
The CHIPS Trial (Control of Hypertension In Pregnancy Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), Sunnybrook Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Hypertension
Keywords
hypertension, pregnancy, antihypertensive therapy, perinatal outcome, maternal outcome, Non-severe, non-proteinuric pre-existing or gestational hypertension in pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
987 (Actual)

8. Arms, Groups, and Interventions

Arm Title
'Less tight' control.
Arm Type
Active Comparator
Arm Description
The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
Arm Title
'Tight' control.
Arm Type
Active Comparator
Arm Description
The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
Intervention Type
Procedure
Intervention Name(s)
Intervention is blood pressure management approach
Intervention Description
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 Type
Procedure
Intervention Name(s)
Intervention is blood pressure management approach.
Intervention Description
'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.
Primary Outcome Measure Information:
Title
Pregnancy Loss or NICU Admission for Greater Than 48 Hours
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Serious Maternal Complications Measured up to 6 Weeks Postpartum
Description
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)
Time Frame
6 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Magee, MD, FRCPC, MSc, FACP
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Norton Hospital Downtown
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Norton Suburban Hospital
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Beth Israel Deaconess
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Meriter Hospital
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
Hospital JR Vidal
City
Corrientes
Country
Argentina
Facility Name
Hospital LC Lagomaggiore
City
Mendoza
Country
Argentina
Facility Name
Hospital JM Cullen
City
Santa Fe
Country
Argentina
Facility Name
Hospital Avellaneda
City
Tucuman
Country
Argentina
Facility Name
Campbelltown Hospital
City
Campbelltown
State/Province
New South Wales
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
Country
Australia
Facility Name
Women's and Children's Hospital
City
Adelaide
Country
Australia
Facility Name
Ipswich Hospital
City
Ipswich
Country
Australia
Facility Name
King Edward Memorial Hospital
City
Subiaco
Country
Australia
Facility Name
St John of God Hospital
City
Subiaco
Country
Australia
Facility Name
Hospital Materno Infantil
City
Goiania
Country
Brazil
Facility Name
Hospital Universitario Antonio Pedro
City
Niteroi
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
Country
Brazil
Facility Name
Maternidade Escola da UFRJ
City
Rio de Janeiro
Country
Brazil
Facility Name
Clinica Perinatal Barra
City
Rio de Janerio
Country
Brazil
Facility Name
Laranjeiras Clinica Perinatal
City
Rio de Janerio
Country
Brazil
Facility Name
Maternidade Escola de Vila Nova Cachoeirinha
City
Sao Paulo
Country
Brazil
Facility Name
Calgary Health Region - Foothills Hospital
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Jim Pattison Outpatient Care and Surgery Centre
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
University of British Columbia, Department of Obstetrics & Gynaecology
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Facility Name
Children's & Women's Health Centre of BC
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
St Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
St Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Women's Health Centre
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
Ottawa Hospital Civic Division
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Ottawa Hospital General Division
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
St Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto East General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hopital Sainte-Justine
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
CHUS Fleurimont
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Regina General Hospital
City
Regina
Country
Canada
Facility Name
Hospital Base Osorno
City
Osorno
Country
Chile
Facility Name
Hospital Dr Sotero del Rio
City
Puente Alto
Country
Chile
Facility Name
Clinica Materno Infantil Farallones
City
Cali
Country
Colombia
Facility Name
Clinica Versalles
City
Cali
Country
Colombia
Facility Name
Corporacion Conmfenalco Valle - Universidad Libre
City
Cali
Country
Colombia
Facility Name
Tartu University Hospital-Women's Clinic
City
Tartu
Country
Estonia
Facility Name
University of Debrecen
City
Debrecen
Country
Hungary
Facility Name
Ma'ayney Hayeshua Medical Center
City
Bnei Brak
Country
Israel
Facility Name
Hillel Yaffe Medical Center
City
Hadera
Country
Israel
Facility Name
Nazareth Hospital (EMMS)
City
Nazareth
Country
Israel
Facility Name
Islamic Hospital
City
Amman
Country
Jordan
Facility Name
Jeroen Bosch Hospital
City
's-Hertogenbosch
Country
Netherlands
Facility Name
Flevo ziekenhuis
City
Almere
Country
Netherlands
Facility Name
Meander Medisch Centrum
City
Amersfoort
Country
Netherlands
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
OLVG
City
Amsterdam
Country
Netherlands
Facility Name
VU Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
UMCG
City
Groningen
Country
Netherlands
Facility Name
Kennemer Gasthuis Haarlem
City
Haarlem
Country
Netherlands
Facility Name
Tergooiziekenhuizen
City
Hilversum
Country
Netherlands
Facility Name
Spaarne Ziekenhuis
City
Hoofddorp
Country
Netherlands
Facility Name
MUMC Maastricht
City
Maastricht
Country
Netherlands
Facility Name
St Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Ziekenhuis Bernhoven
City
Oss
Country
Netherlands
Facility Name
Diakonessen Ziekenhuis
City
Utrecht
Country
Netherlands
Facility Name
UMCU
City
Utrecht
Country
Netherlands
Facility Name
Maxima Medical Centre
City
Veldhoven
Country
Netherlands
Facility Name
Isala Klinieken Zwolle
City
Zwolle
Country
Netherlands
Facility Name
Waitemata Health-North Shore Hospital
City
Auckland
Country
New Zealand
Facility Name
Christchurch Women's Hospital
City
Christchurch
Country
New Zealand
Facility Name
Medical University of Gdansk
City
Gdansk
Country
Poland
Facility Name
Polish Mothers Memorial Hospital
City
Lodz
Country
Poland
Facility Name
University School of Medical Sciences
City
Poznan
Country
Poland
Facility Name
Basildon & Thurrock University Hospital
City
Basildon
Country
United Kingdom
Facility Name
Birmingham Women's Hospital
City
Birmingham
Country
United Kingdom
Facility Name
East Lancashire Hospitals NHS Trust
City
Blackburn
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
Country
United Kingdom
Facility Name
Chesterfield Royal Hospital
City
Chesterfield
Country
United Kingdom
Facility Name
University Hospital Coventry and Warwickshire
City
Coventry
Country
United Kingdom
Facility Name
The Royal Derby Hospital
City
Derby
Country
United Kingdom
Facility Name
Calderdale Royal Hospital
City
Halifax
Country
United Kingdom
Facility Name
Lancashire Teaching Hospitals NHS Foundation Trust
City
Lancashire
Country
United Kingdom
Facility Name
Royal Lancaster Infirmary
City
Lancaster
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
Country
United Kingdom
Facility Name
Liverpool Women's Hospital
City
Liverpool
Country
United Kingdom
Facility Name
Guy's & St Thomas' Hospital
City
London
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
London
Country
United Kingdom
Facility Name
St Mary's Hospital
City
Manchester
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
Country
United Kingdom
Facility Name
King's Mill Hospital
City
Nottinghamshire
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
Country
United Kingdom
Facility Name
Southport & Ormskirk Hospital
City
Ormskirk
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
Country
United Kingdom
Facility Name
Wexham Park Hospital
City
Slough
Country
United Kingdom
Facility Name
City Hospitals Sunderland NHS Foundation Trust
City
Sunderland
Country
United Kingdom
Facility Name
Singleton Hospital
City
Swansea
Country
United Kingdom
Facility Name
South Warwickshire NHS Trust
City
Warwickshire
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
Country
United Kingdom
Facility Name
York District Hospital
City
York
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31927325
Citation
Magee LA, Singer J, Lee T, McManus RJ, Lay-Flurrie S, Rey E, Chappell LC, Myers J, Logan AG, von Dadelszen P. Are blood pressure level and variability related to pregnancy outcome? Analysis of control of hypertension in pregnancy study data. Pregnancy Hypertens. 2020 Jan;19:87-93. doi: 10.1016/j.preghy.2019.12.002. Epub 2020 Jan 9.
Results Reference
derived
PubMed Identifier
27665372
Citation
Vidler M, Magee LA, von Dadelszen P, Rey E, Ross S, Asztalos E, Murphy KE, Menzies J, Sanchez J, Singer J, Gafni A, Gruslin A, Helewa M, Hutton E, Lee SK, Lee T, Logan AG, Ganzevoort W, Welch R, Thornton JG, Moutquin JM; CHIPS Study Group. Women's views and postpartum follow-up in the CHIPS Trial (Control of Hypertension in Pregnancy Study). Eur J Obstet Gynecol Reprod Biol. 2016 Nov;206:105-113. doi: 10.1016/j.ejogrb.2016.07.509. Epub 2016 Sep 10.
Results Reference
derived
PubMed Identifier
27620393
Citation
Magee LA, von Dadelszen P, Singer J, Lee T, Rey E, Ross S, Asztalos E, Murphy KE, Menzies J, Sanchez J, Gafni A, Helewa M, Hutton E, Koren G, Lee SK, Logan AG, Ganzevoort W, Welch R, Thornton JG, Moutquin JM; CHIPS Study Group*. The CHIPS Randomized Controlled Trial (Control of Hypertension in Pregnancy Study): Is Severe Hypertension Just an Elevated Blood Pressure? Hypertension. 2016 Nov;68(5):1153-1159. doi: 10.1161/HYPERTENSIONAHA.116.07862. Epub 2016 Sep 12.
Results Reference
derived
PubMed Identifier
27550914
Citation
Ahmed RJ, Gafni A, Hutton EK, Hu ZJ, Pullenayegum E, von Dadelszen P, Rey E, Ross S, Asztalos E, Murphy KE, Menzies J, Sanchez JJ, Ganzevoort W, Helewa M, Lee SK, Lee T, Logan AG, Moutquin JM, Singer J, Thornton JG, Welch R, Magee LA. The Cost Implications of Less Tight Versus Tight Control of Hypertension in Pregnancy (CHIPS Trial). Hypertension. 2016 Oct;68(4):1049-55. doi: 10.1161/HYPERTENSIONAHA.116.07466. Epub 2016 Aug 22.
Results Reference
derived
PubMed Identifier
25629739
Citation
Magee LA, von Dadelszen P, Rey E, Ross S, Asztalos E, Murphy KE, Menzies J, Sanchez J, Singer J, Gafni A, Gruslin A, Helewa M, Hutton E, Lee SK, Lee T, Logan AG, Ganzevoort W, Welch R, Thornton JG, Moutquin JM. Less-tight versus tight control of hypertension in pregnancy. N Engl J Med. 2015 Jan 29;372(5):407-17. doi: 10.1056/NEJMoa1404595.
Results Reference
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The CHIPS Trial (Control of Hypertension In Pregnancy Study)

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