The CHIPS Trial (Control of Hypertension In Pregnancy Study)

Gestational Hypertension Clinical Trial

Official title:

The CHIPS Trial (Control of Hypertension In Pregnancy Study)

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

Related Conditions & MeSH terms

• Gestational Hypertension
• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia

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