Clinical Trial: The CHIPS Trial (Control of Hypertension In Pregnancy Study)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The CHIPS Trial (Control of Hypertension In Pregnancy Study)

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 Summary:

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
    Sponsor: University of British Columbia

    Current 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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Serious Maternal Complications Measured up to 6 Weeks Postpartum [ Time Frame: 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)


    Original Secondary Outcome: Same as current

    Information By: University of British Columbia

    Dates:
    Date Received: August 30, 2010
    Date Started: April 2009
    Date Completion:
    Last Updated: November 15, 2016
    Last Verified: November 2016