Ignite Creation Date:
2024-05-05 @ 10:51 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01192412
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2010-08-30
Brief Title:
The CHIPS Trial Control of Hypertension In Pregnancy Study
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
The CHIPS Trial Control of Hypertension In Pregnancy Study
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 eg 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 Onemore serious maternal complications 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 womans and babys 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 maternalneonatal morbidity following hospital discharge
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 eg 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 Onemore serious maternal complications 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 womans and babys 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 maternalneonatal morbidity following hospital discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-3431 | OTHER | UBC | None |
| MCT-87522 | OTHER_GRANT | None | None |