Gestational HypertensionNCT01192412
The CHIPS Trial (Control of Hypertension In Pregnancy Study)
A study testing Intervention is blood pressure management approach and Intervention is blood pressure management approach. in people with Gestational Hypertension, run by University of British Columbia at 111 sites in 15 countries.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Hypertension
- What is being tested?
- Intervention is blood pressure management approach and Intervention is blood pressure management approach.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 987 participants
- Where
- 111 sitesin 15 countries
- Study dates
- Apr 2009to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
111 sites in 15 countries.
111 sites in 15 countries
United Kingdom28 sites
Basildon & Thurrock University Hospital
Basildon
Birmingham Women's Hospital
Birmingham
East Lancashire Hospitals NHS Trust
Blackburn
Bradford Royal Infirmary
Bradford
Chesterfield Royal Hospital
Chesterfield
University Hospital Coventry and Warwickshire
Coventry
The Royal Derby Hospital
Derby
Calderdale Royal Hospital
Halifax
Lancashire Teaching Hospitals NHS Foundation Trust
Lancashire
Royal Lancaster Infirmary
Lancaster
Leicester Royal Infirmary
Leicester
Liverpool Women's Hospital
Liverpool
Guy's & St Thomas' Hospital
London
Queen Elizabeth Hospital
London
St Mary's Hospital
Manchester
Royal Victoria Infirmary
Newcastle upon Tyne
Nottingham City Hospital
Nottingham
Queen's Medical Centre
Nottingham
King's Mill Hospital
Nottinghamshire
Southport & Ormskirk Hospital
Ormskirk
Derriford Hospital
Plymouth
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Wexham Park Hospital
Slough
City Hospitals Sunderland NHS Foundation Trust
Sunderland
Singleton Hospital
Swansea
South Warwickshire NHS Trust
Warwickshire
New Cross Hospital
Wolverhampton
York District Hospital
York
Canada21 sites
Calgary Health Region - Foothills Hospital
Calgary, Alberta
Royal Alexandra Hospital
Edmonton, Alberta
IWK Health Centre
Halifax, Nova Scotia
London Health Sciences Centre
London, Ontario
Hopital Sainte-Justine
Montreal, Quebec
Royal Victoria Hospital
Montreal, Quebec
Ottawa Hospital Civic Division
Ottawa, Ontario
Ottawa Hospital General Division
Ottawa, Ontario
Regina General Hospital
Regina
Royal University Hospital
Saskatoon, Saskatchewan
CHUS Fleurimont
Sherbrooke, Quebec
Women's Health Centre
St. John's, Newfoundland and Labrador
Jim Pattison Outpatient Care and Surgery Centre
Surrey, British Columbia
Mount Sinai Hospital
Toronto, Ontario
St Michael's Hospital
Toronto, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario
Toronto East General Hospital
Toronto, Ontario
University of British Columbia, Department of Obstetrics & Gynaecology
Vancouver, British Columbia, V6H 3N1
Children's & Women's Health Centre of BC
Vancouver, British Columbia
St Paul's Hospital
Vancouver, British Columbia
St Boniface General Hospital
Winnipeg, Manitoba
Netherlands18 sites
Jeroen Bosch Hospital
's-Hertogenbosch
Flevo ziekenhuis
Almere Stad
Meander Medisch Centrum
Amersfoort
Academic Medical Center
Amsterdam
OLVG
Amsterdam
VU Medical Center
Amsterdam
Medisch Spectrum Twente
Enschede
UMCG
Groningen
Kennemer Gasthuis Haarlem
Haarlem
Tergooiziekenhuizen
Hilversum
Spaarne Ziekenhuis
Hoofddorp
MUMC Maastricht
Maastricht
St Antonius Ziekenhuis
Nieuwegein
Ziekenhuis Bernhoven
Oss
Diakonessen Ziekenhuis
Utrecht
UMCU
Utrecht
Maxima Medical Centre
Veldhoven
Isala Klinieken Zwolle
Zwolle
United States11 sites
Beth Israel Deaconess
Boston, Massachusetts
Cooper University Hospital
Camden, New Jersey
University of North Carolina
Chapel Hill, North Carolina
Medical University of South Carolina
Charleston, South Carolina
East Carolina University
Greenville, North Carolina
Norton Hospital Downtown
Louisville, Kentucky
Norton Suburban Hospital
Louisville, Kentucky
Meriter Hospital
Madison, Wisconsin
University of Minnesota
Minneapolis, Minnesota
Yale-New Haven Hospital
New Haven, Connecticut
Oregon Health and Science University
Portland, Oregon
Brazil7 sites
Hospital Materno Infantil
Goiânia
Hospital Universitario Antonio Pedro
Niterói
Hospital Sao Lucas - PUCRS
Porto Alegre
Maternidade Escola da UFRJ
Rio de Janeiro
Clinica Perinatal Barra
Rio de Janerio
Laranjeiras Clinica Perinatal
Rio de Janerio
Maternidade Escola de Vila Nova Cachoeirinha
São Paulo
Australia6 sites
Women's and Children's Hospital
Adelaide
Campbelltown Hospital
Campbelltown, New South Wales
Ipswich Hospital
Ipswich
Liverpool Hospital
Liverpool, New South Wales
King Edward Memorial Hospital
Subiaco
St John of God Hospital
Subiaco
Argentina4 sites
Hospital JR Vidal
Corrientes
Hospital LC Lagomaggiore
Mendoza
Hospital Avellaneda
San Miguel de Tucumán
Hospital JM Cullen
Santa Fe
Colombia3 sites
Clinica Materno Infantil Farallones
Cali
Clinica Versalles
Cali
Corporacion Conmfenalco Valle - Universidad Libre
Cali
Israel3 sites
Ma'ayney Hayeshua Medical Center
Bnei Brak
Hillel Yaffe Medical Center
Hadera
Nazareth Hospital (EMMS)
Nazareth
Poland3 sites
Medical University of Gdansk
Gdansk
Polish Mothers Memorial Hospital
Lodz
University School of Medical Sciences
Poznan
New Zealand2 sites
Waitemata Health-North Shore Hospital
Auckland
Christchurch Women's Hospital
Christchurch
About this study
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.
Read the 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.
- Conditions
- Gestational Hypertension
- Being tested
- Intervention is blood pressure management approach, Intervention is blood pressure management approach.
- Keywords
- hypertension, pregnancy, antihypertensive therapy, perinatal outcome, maternal outcome, Non-severe, non-proteinuric pre-existing or gestational hypertension in pregnancy
- Medical subject headings
- Hypertension, Pregnancy-Induced, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention is blood pressure management approachProcedure or surgery
- '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.Procedure or surgery
'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.
| Study group | Role | What they receive |
|---|---|---|
| 'Less tight' control. | Active comparator | The diastolic blood pressure (dBP) treatment goal is 100 mmHg. Receives: Procedure: Intervention is blood pressure management approach |
| 'Tight' control. | Active comparator | The diastolic blood pressure (dBP) treatment goal is 85 mmHg. Receives: Procedure: Intervention is blood pressure management approach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
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)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startApr 2009
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 987 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Sunnybrook Research Institute
- Responsible party
- Sponsor
- Investigators
- Laura A Magee, MD, FRCPC, MSc, FACP, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192412
- Sponsor's protocol ID
- H08-00882
- Other IDs
- MCT-87522, 07-3431
- Status last verified
- Nov 2016
- First submitted
- 30 Aug 2010
- Last updated
- 11 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Metcalfe RK, Harrison M, Singer J, Lewisch M, Lee T, von Dadelszen P, Magee LA, Bansback N; CHIPS Study Group. Using a patient-centred composite endpoint in a secondary analysis of the Control of Hypertension in Pregnancy Study (CHIPS) Trial. Trials. 2023 Feb 7;24(1):99. doi: 10.1186/s13063-023-07118-1.
PubMed 36750953Magee 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.
PubMed 31927325Vidler 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.
PubMed 27665372Magee 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.
PubMed 27620393Ahmed 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.
PubMed 27550914Magee 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.
PubMed 25629739
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CHIPS Trial (Control of Hypertension In Pregnancy Study)
- ClinicalTrials.gov ID
- NCT01192412
- Acronym / sponsor ID
- H08-00882
- Conditions
- Gestational Hypertension
- Keywords
- hypertension, pregnancy, antihypertensive therapy, perinatal outcome, maternal outcome, Non-severe, non-proteinuric pre-existing or gestational hypertension in pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 987 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Sunnybrook Research Institute
- Study start
- Apr 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Posted 11 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'Less tight' control. | Active comparator | Procedure: Intervention is blood pressure management approachThe diastolic blood pressure (dBP) treatment goal is 100 mmHg. |
| 'Tight' control. | Active comparator | Procedure: Intervention is blood pressure management approach.The diastolic blood pressure (dBP) treatment goal is 85 mmHg. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention is blood pressure management approach1) '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. | Procedure or surgery | 'Less tight' control. |
| 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. | Procedure or surgery | 'Tight' control. |
Primary outcome
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.
1 secondary outcome
Serious Maternal Complications Measured up to 6 Weeks Postpartum
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36750953Metcalfe RK, Harrison M, Singer J, Lewisch M, Lee T, von Dadelszen P, Magee LA, Bansback N; CHIPS Study Group. Using a patient-centred composite endpoint in a secondary analysis of the Control of Hypertension in Pregnancy Study (CHIPS) Trial. Trials. 2023 Feb 7;24(1):99. doi: 10.1186/s13063-023-07118-1.
- Derived from this study: PubMed 31927325Magee 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.
- Derived from this study: PubMed 27665372Vidler 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.
- Derived from this study: PubMed 27620393Magee 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.
- Derived from this study: PubMed 27550914Ahmed 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.
- Derived from this study: PubMed 25629739Magee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A Magee, MD, FRCPC, MSc, FACP principal investigator
The University of British Columbia
111 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention is blood pressure management approach and Intervention is blood pressure management approach. in people with Gestational Hypertension, run by University of British Columbia at 111 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 111 sites in United Kingdom, Canada, Netherlands, United States, Brazil and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Loss or NICU Admission for Greater Than 48 Hours (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01192412, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.