Trial Outcomes & Findings for The CHIPS Trial (Control of Hypertension In Pregnancy Study) (NCT NCT01192412)
NCT ID: NCT01192412
Last Updated: 2017-01-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
987 participants
Primary outcome timeframe
6 weeks
Results posted on
2017-01-11
Participant Flow
Participant milestones
| Measure |
'Less Tight' Control.
The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
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.
|
'Tight' Control.
The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
497
|
490
|
|
Overall Study
COMPLETED
|
493
|
488
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
'Less Tight' Control.
The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
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.
|
'Tight' Control.
The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
The CHIPS Trial (Control of Hypertension In Pregnancy Study)
Baseline characteristics by cohort
| Measure |
'Less Tight' Control.
n=497 Participants
The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
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.
|
'Tight' Control.
n=490 Participants
The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
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.
|
Total
n=987 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.0 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
33.7 years
STANDARD_DEVIATION 5.8 • n=107 Participants
|
33.8 years
STANDARD_DEVIATION 5.8 • n=206 Participants
|
|
Gender
Female
|
497 Participants
n=99 Participants
|
490 Participants
n=107 Participants
|
987 Participants
n=206 Participants
|
|
Gender
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Body-mass index
<18.5 kg/m^2
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Body-mass index
18.5-24.9 kg/m^2
|
116 participants
n=99 Participants
|
112 participants
n=107 Participants
|
228 participants
n=206 Participants
|
|
Body-mass index
25.0-29.9 kg/m^2
|
131 participants
n=99 Participants
|
135 participants
n=107 Participants
|
266 participants
n=206 Participants
|
|
Body-mass index
≥30.0 kg/m^2
|
245 participants
n=99 Participants
|
236 participants
n=107 Participants
|
481 participants
n=206 Participants
|
|
Cigarette smoking during this pregnancy
|
35 participants
n=99 Participants
|
28 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
Nulliparous
|
161 participants
n=99 Participants
|
168 participants
n=107 Participants
|
329 participants
n=206 Participants
|
|
Weeks of gestation
|
23.7 weeks
STANDARD_DEVIATION 6.3 • n=99 Participants
|
24.2 weeks
STANDARD_DEVIATION 6.3 • n=107 Participants
|
23.9 weeks
STANDARD_DEVIATION 6.3 • n=206 Participants
|
|
Type of nonproteinuric hypertension
Preexisting hypertension
|
371 participants
n=99 Participants
|
365 participants
n=107 Participants
|
736 participants
n=206 Participants
|
|
Type of nonproteinuric hypertension
Gestational hypertension
|
126 participants
n=99 Participants
|
125 participants
n=107 Participants
|
251 participants
n=206 Participants
|
|
Prior blood pressure ≥160 mm Hg systolic or ≥110 mm Hg diastolic during this pregnancy
|
82 participants
n=99 Participants
|
59 participants
n=107 Participants
|
141 participants
n=206 Participants
|
|
Antihypertensive medication at enrollment
|
279 participants
n=99 Participants
|
287 participants
n=107 Participants
|
566 participants
n=206 Participants
|
|
Blood pressure within 1 wk before randomization
Systolic
|
140.4 mmHg
STANDARD_DEVIATION 9.7 • n=99 Participants
|
139.7 mmHg
STANDARD_DEVIATION 9.8 • n=107 Participants
|
140.1 mmHg
STANDARD_DEVIATION 9.8 • n=206 Participants
|
|
Blood pressure within 1 wk before randomization
Diastolic
|
92.6 mmHg
STANDARD_DEVIATION 4.8 • n=99 Participants
|
92.2 mmHg
STANDARD_DEVIATION 5.2 • n=107 Participants
|
92.4 mmHg
STANDARD_DEVIATION 5.0 • n=206 Participants
|
|
Currently monitoring blood pressure at home
|
185 participants
n=99 Participants
|
194 participants
n=107 Participants
|
379 participants
n=206 Participants
|
|
Gestational diabetes at enrollment
|
32 participants
n=99 Participants
|
31 participants
n=107 Participants
|
63 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPregnancy 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.
Outcome measures
| Measure |
'Less Tight' Control.
n=493 Participants
The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
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.
|
'Tight' Control.
n=488 Participants
The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
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.
|
|---|---|---|
|
Pregnancy Loss or NICU Admission for Greater Than 48 Hours
|
155 participants
|
150 participants
|
SECONDARY outcome
Timeframe: 6 weeksSerious 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)
Outcome measures
| Measure |
'Less Tight' Control.
n=493 Participants
The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
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.
|
'Tight' Control.
n=488 Participants
The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
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.
|
|---|---|---|
|
Serious Maternal Complications Measured up to 6 Weeks Postpartum
|
18 participants
|
10 participants
|
Adverse Events
'Less Tight' Control.
Serious events: 155 serious events
Other events: 241 other events
Deaths: 0 deaths
'Tight' Control.
Serious events: 150 serious events
Other events: 223 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
'Less Tight' Control.
n=493 participants at risk
The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
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.
|
'Tight' Control.
n=488 participants at risk
The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
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.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy loss
|
3.0%
15/493
|
3.1%
15/488
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
0.00%
0/493
|
0.20%
1/488
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/493
|
0.00%
0/488
|
|
Pregnancy, puerperium and perinatal conditions
Elective termination
|
0.20%
1/493
|
0.20%
1/488
|
|
Pregnancy, puerperium and perinatal conditions
Perinatal death
|
2.8%
14/493
|
2.3%
11/488
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
2.4%
12/493
|
1.4%
7/488
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal death
|
0.41%
2/493
|
0.82%
4/488
|
|
Pregnancy, puerperium and perinatal conditions
High-level neonatal care for >48hr
|
29.4%
141/480
|
29.0%
139/479
|
|
Pregnancy, puerperium and perinatal conditions
Birthweight <10th percentile
|
16.1%
79/491
|
19.7%
96/488
|
|
Pregnancy, puerperium and perinatal conditions
Birthweight <3rd percentile
|
4.7%
23/491
|
5.3%
26/488
|
|
Cardiac disorders
Uncontrolled hypertension
|
0.00%
0/493
|
0.00%
0/488
|
|
Nervous system disorders
Transient ischemic attack or stroke
|
0.00%
0/493
|
0.20%
1/488
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.41%
2/493
|
0.20%
1/488
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/493
|
0.20%
1/488
|
|
Blood and lymphatic system disorders
Transfusion
|
3.2%
16/493
|
1.6%
8/488
|
Other adverse events
| Measure |
'Less Tight' Control.
n=493 participants at risk
The diastolic blood pressure (dBP) treatment goal is 100 mmHg.
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.
|
'Tight' Control.
n=488 participants at risk
The diastolic blood pressure (dBP) treatment goal is 85 mmHg.
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.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Placental abruption
|
2.2%
11/493
|
2.3%
11/488
|
|
Cardiac disorders
Severe hypertension
|
40.6%
200/493
|
27.5%
134/488
|
|
Pregnancy, puerperium and perinatal conditions
Preeclampsia
|
48.9%
241/493
|
45.7%
223/488
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place