Hypertension
Conditions
Keywords
Pregnancy, Chronic hypertension
Brief summary
The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (\<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe.
Detailed description
During pregnancy, chronic hypertension (CHTN) is the most common major medical disorder encountered, occurring in 2-6%. The substantial negative effect of CHTN on pregnancy includes a consistent 3- to 5-fold increase in superimposed preeclampsia and adverse perinatal outcomes (fetal or neonatal death, preterm birth -PTB, poor fetal growth and placental abruption) and possibly a 5- to10-fold increase in maternal cardiovascular and other complications (death, cerebrovascular accident, pulmonary edema and acute renal failure). Mild CHTN (BP \<160/110) contributes to a large proportion of these adverse outcomes. While antihypertensive treatment of CHTN is standard for the general population, it is uncertain whether treatment during pregnancy reduces maternal or fetal complications, and there are concerns that decreased arterial pressure may reduce fetal blood flow and cause poor fetal growth or small-for-gestational-age (SGA) infants. Some authorities, including the American College of Obstetricians and Gynecologists (ACOG) and American Society of Hypertension (ASH) recommend withholding antihypertensive therapy for mild CHTN, particularly if BP is \<160/105-110 mmHg. The recommendation to withhold antihypertensive treatment in pregnancy conflicts with the broader public health goal to reduce BP in those with CHTN and there is no evidence that discontinuing therapy during the brief period of pregnancy affects maternal outcomes (other than reducing the severe hypertension). For over a decade, authorities have consistently called for well-designed and powered trials to delineate the benefits and risks of pharmacologic therapy for CHTN during pregnancy. Therefore, our multicenter consortium proposes the Chronic Hypertension and Pregnancy (CHAP) Project, a large pragmatic randomized trial with a primary aim to evaluate the benefits and harms of pharmacologic treatment of mild CHTN in pregnancy.
Interventions
DRUGAnti-hypertensive therapy
1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
OTHERNo anti-hypertensive therapy (unless BP is severe)
Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Sponsors
Columbia University
Drexel University College of Medicine
Rutgers, The State University of New Jersey
Lehigh Valley Hospital
Saint Peters University Hospital
Christiana Care Health Services
Washington University School of Medicine
Duke University
University of Texas Southwestern Medical Center
The University of Texas Health Science Center, Houston
Stanford University
University of Pennsylvania
The University of Texas Medical Branch, Galveston
University of Utah
Intermountain Health Care, Inc.
University of California, San Francisco
Johns Hopkins University
University of Pittsburgh
Ochsner Health System
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
WakeMed Health and Hospitals
San Francisco General Hospital
McKay-Dee Hospital
Winthrop University Hospital
New York Hospital Queens
Latter Day Saints Hospital
Lyndon B Johnson General Hospital
Virtua Medical Group
Duke Regional Hospital
Utah Valley Regional Medical Center
Northwestern University
Women and Infants Hospital of Rhode Island
Baylor College of Medicine
Case Western/Metro Health
Ohio State University
University of Iowa
University of California, San Diego
Indiana University
Meriter Foundation
Weill Medical College of Cornell University
University of Oklahoma
Medical University of South Carolina
Beaumont Hospital
University of Colorado, Denver
University of Kansas Medical Center
Denver Health and Hospital Authority
Gundersen Health System
Wake Forest University Health Sciences
Oregon Health and Science University
Medical College of Wisconsin
Temple University
New Jersey Medical School
University of South Alabama
Vanderbilt University
University of Arkansas
Emory University
St. Luke's Hospital and Health Network, Pennsylvania
The Cleveland Clinic
University of Tennessee
TriHealth Inc.
Tulane University
Yale University
Arrowhead Regional Medical Center
Geisinger Clinic
Miami Valley Hospital
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women with chronic hypertension in pregnancy with new or untreated chronic hypertension, blood pressure 140-159 systolic or 90-104 diastolic OR known chronic hypertension on monotherapy and taking any antihypertensive and blood pressure ≤159/104 (including those with blood pressure \<140/90); 2. Singleton; and 3. viable pregnancy \<23 weeks of gestation.
Exclusion criteria
1. Blood pressures prior to randomization ≥160 systolic or ≥105 diastolic (with or without treatment); 2. Severe hypertension including patients currently treated with \>1 antihypertensive medication (more likely to have severe chronic hypertension); 3. Multi-fetal pregnancy; 4. Known secondary cause of chronic hypertension; 5. High-risk co-morbidities for which treatment may be indicated: * Diabetes mellitus diagnosed at age ≤10 years or duration of diagnosis ≥20 years * Diabetes mellitus complicated by end organ damage (retinopathy, nephropathy, heart disease, transplant) * Chronic kidney disease - including baseline proteinuria (\>300mg/24-hr, protein/creatinine ratio ≥0.3, or persistent 1+ proteinuria\*) or creatinine \>1.2. \*If a dipstick value at screening is more than trace, a clean catch or catheter urine should be obtained and re-tested by dipstick. If this shows trace or absence of protein, the patient is included. If it again shows 1+ protein, the patient is excluded until a 24-hr urine \<300mg/24hr or p/c ratio is \<0.3. If a p/c ratio is \>0.3, the patient may be included if a 24-hour urine is \< 300 mg. * Cardiac disorders: cardiomyopathy, angina, CAD * Prior stroke * Retinopathy * Sickle cell disease 6. Known major fetal anomaly; 7. Known fetal demise; 8. Suspected IUGR; 9. Membrane rupture or planned termination prior to randomization; 10. Plan to deliver outside the consortium centers (unless approved by the Clinical Coordinating Center) or unlikely to follow-up in the opinion of study staff or previous participation in this trial; 11. Contraindication to labetalol and nifedipine (e.g. know hypersensitivity); 12. Current substance abuse or addiction (cocaine, methamphetamine) 13. Participation in another trial without prior approval (CHAP participants will not be enrolled in other trials without prior approval by protocol committee) 14. Physician or provider refusal 15. Patient refusal \*The minimum age varies by center
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Adverse Perinatal Outcome | Up to 2 weeks postpartum for preeclampsia or 90 days for neonatal death | One or more severe outcomes including fetal death or neonatal death up to discharge or 90 days if prior; preeclampsia with severe features up to 2 weeks postpartum (Severe hypertension and proteinuria or hypertension and severe features per ACOG); placental abruption; or indicated PTB \<35 weeks (not due to spontaneous preterm labor or membrane rupture). |
| Small for Gestational Age (Safety) | Until delivery | Birth weight less than 10th percentile for gestational age at birth according to accepted national standard |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preterm Birth and Indicated Preterm Birth (<37 Weeks) | Until delivery | Preterm birth and Indicated preterm birth (\<37 weeks) includes any preterm birth less than 37 weeks |
| Composite of Maternal Death or Severe Cardiovascular Morbidity | Up to 6 weeks (4-12 weeks) after delivery | One or more of maternal death, new heart failure, stroke, encephalopathy, angina, myocardial infarction or ischemia, pulmonary edema, ICU admission/intubation, or renal failure |
| Adherence to Treatment After Delivery | 6 weeks (4-12 weeks) after delivery | Counts with high adherence to antihypertensive therapy after delivery for those prescribed medications. |
| Composite of Severe Neonatal Morbidities | Up to 90 days post delivery | One or more of Bronchopulmonary dysplasia (BPD), Retinopathy of prematurity (ROP), Necrotizing enterocolitis (NEC), Intraventricular hemorrhage (VH) grade III/IV |
| Severe Maternal Hypertension + Components of the Primary Composite Endpoint | Up to 2 weeks postpartum or 90 days for neonatal death | Persistent severe hypertension with or without proteinuria + the primary composite |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ponderal Index | At birth | Mean ponderal index, mass/height\^3 at birth |
| Head Circumference | At birth | Mean head circumference |
| Placental Weight | At delivery | Mean placental weight |
| Hypoglycemia | From delivery to hospital discharge (2 - 3 days after delivery) | Prevalence of hypoglycemia |
| Bradycardia | From delivery to hospital discharge (2 - 3 days after delivery) | Prevalence of bradycardia |
| Hypotension | From delivery to hospital discharge (2 - 3 days after delivery) | Incidence (%) with hypotension |
| Respiratory Distress Syndrome (RDS) | From delivery to hospital discharge (2 - 3 days after delivery) | Incidence (%) with respiratory distress syndrome (RDS) |
| Bronchopulmonary Dysplasia (BPD) | Up to 3 months after delivery | Incidence (%) with bronchopulmonary dysplasia (BPD) |
| Intubation/Ventilation | From delivery to hospital discharge (2 - 3 days after delivery) | Incidence (%) with resuscitation including oxygen, intubation, chest compression/CPR, or CPAP |
| Superimposed Preeclampsia | Up to 2 weeks after delivery | Mild or severe, including eclampsia |
| Necrotizing Enterocolitis (NEC) | Up to 3 months after delivery | Incidence (%) with necrotizing enterocolitis (NEC) |
| Hyperbilirubinemia | From delivery to hospital discharge (2 - 3 days after delivery) | Incidence (%) with hyperbilirubinemia |
| 5-min Apgar Score | At delivery | Incidence (%) with Apgar score \<7 (range 0-10 with lower scores indicating worse outcome) |
| Sepsis | From delivery to hospital discharge (2 - 3 days after delivery) | Incidence (%) with proven sepsis |
| Unscheduled Prenatal Clinic or ER Visits | Up to 3 months after delivery | Number of unscheduled clinic or ER visits before and after delivery |
| Hospitalizations | Up to 3 months postpartum | Number of hospitalizations before or after delivery |
| Postpartum Unscheduled or ER Visits | Up to 3 months after delivery | Number of postpartum unscheduled or ER visits |
| Postpartum Hospitalizations | Up to 3 months after delivery | Number of postpartum hospitalizations |
| Neonatal Hospital Stay of 3 or More Days | after delivery | Frequency of neonatal hospital stays lasting at least 3 days |
| Intraventricular Hemorrhage (IVH) | From delivery to hospital discharge (2 - 3 days after delivery) | Incidence (%) with any IVH and with IVH Grades III and IV |
| Superimposed Gestational Hypertension | Enrollment (between 6 and 18 weeks gestation) to delivery | Persistent worsening hypertension above baseline without pree or proteinuria occurring after 20 weeks gestation |
| Severe Hypertension | Up to 6 weeks (4-12 weeks) after delivery | Blood pressure ≥160/110 |
| Cesarean Delivery | Until delivery | Cesarean delivery |
| Blood Transfusion | Up to 6 weeks | During pregnancy or postpartum |
| NICU Admission | Up to 6 weeks (4-12 weeks) after delivery | Any NICU admission |
| Low Birth Weight | At birth | Birth weight \<2500g |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg Labetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used
Anti-hypertensive therapy: 1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol) | 1,208 |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg Antihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used
No anti-hypertensive therapy (unless BP is severe): Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105. | 1,200 |
| Total | 2,408 |
Baseline characteristics
| Characteristic | Total | Anti-hypertensive Therapy to Goal <140/90 mmHg | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg |
|---|---|---|---|
| Age, Continuous | 32.3 years STANDARD_DEVIATION 5.7 | 32.3 years STANDARD_DEVIATION 5.6 | 32.3 years STANDARD_DEVIATION 5.8 |
| Aspirin Use | 1075 Participants | 539 Participants | 536 Participants |
| Blood Pressure - Diastolic | 83.7 mmHg STANDARD_DEVIATION 9.6 | 83.9 mmHg STANDARD_DEVIATION 9.5 | 83.4 mmHg STANDARD_DEVIATION 9.6 |
| Blood Pressure - Systolic | 134.0 mmHg STANDARD_DEVIATION 12.6 | 134.3 mmHg STANDARD_DEVIATION 12.7 | 133.7 mmHg STANDARD_DEVIATION 12.4 |
| BMI | 37.6 kg/m^2 STANDARD_DEVIATION 9.8 | 37.7 kg/m^2 STANDARD_DEVIATION 10 | 37.5 kg/m^2 STANDARD_DEVIATION 9.6 |
| Current Smoker | 174 Participants | 92 Participants | 82 Participants |
| Diabetes Mellitus | 380 Participants | 191 Participants | 189 Participants |
| Gestational Age less than 14 weeks | 977 Participants | 496 Participants | 481 Participants |
| Insurance Type Government-assisted or Medicaid | 1329 Participants | 673 Participants | 656 Participants |
| Insurance Type Missing data | 32 Participants | 16 Participants | 16 Participants |
| Insurance Type None | 125 Participants | 60 Participants | 65 Participants |
| Insurance Type Private | 922 Participants | 459 Participants | 463 Participants |
| Prior Pregnancy | 1996 Participants | 1007 Participants | 989 Participants |
| Race/Ethnicity, Customized Race or Ethnic Group Hispanic | 488 Participants | 238 Participants | 250 Participants |
| Race/Ethnicity, Customized Race or Ethnic Group Non-Hispanic Black | 1144 Participants | 574 Participants | 570 Participants |
| Race/Ethnicity, Customized Race or Ethnic Group Non-Hispanic White | 673 Participants | 347 Participants | 326 Participants |
| Race/Ethnicity, Customized Race or Ethnic Group Other | 103 Participants | 49 Participants | 54 Participants |
| Region of Enrollment United States | 2408 participants | 1208 participants | 1200 participants |
| Sex: Female, Male Female | 2408 Participants | 1208 Participants | 1200 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Type of CHTN Diagnosed and not receiving medication | 529 Participants | 268 Participants | 261 Participants |
| Type of CHTN Diagnosed and receiving medication | 1358 Participants | 677 Participants | 681 Participants |
| Type of CHTN Newly diagnosed | 521 Participants | 263 Participants | 258 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 42 / 1,208 | 52 / 1,200 |
| other Total, other adverse events | 0 / 1,208 | 0 / 1,200 |
| serious Total, serious adverse events | 113 / 1,208 | 126 / 1,200 |
Outcome results
Primary
Composite Adverse Perinatal Outcome
One or more severe outcomes including fetal death or neonatal death up to discharge or 90 days if prior; preeclampsia with severe features up to 2 weeks postpartum (Severe hypertension and proteinuria or hypertension and severe features per ACOG); placental abruption; or indicated PTB \<35 weeks (not due to spontaneous preterm labor or membrane rupture).
Time frame: Up to 2 weeks postpartum for preeclampsia or 90 days for neonatal death
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Composite Adverse Perinatal Outcome | Preeclampsia with Severe Features | 272 Participants |
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Composite Adverse Perinatal Outcome | Placental Abruption | 20 Participants |
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Composite Adverse Perinatal Outcome | Indicated Preterm Birth <35 weeks | 143 Participants |
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Composite Adverse Perinatal Outcome | Fetal or Neonatal Death <28 days | 41 Participants |
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Composite Adverse Perinatal Outcome | Composite Primary Outcome | 353 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Composite Adverse Perinatal Outcome | Fetal or Neonatal Death <28 days | 50 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Composite Adverse Perinatal Outcome | Composite Primary Outcome | 427 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Composite Adverse Perinatal Outcome | Preeclampsia with Severe Features | 336 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Composite Adverse Perinatal Outcome | Indicated Preterm Birth <35 weeks | 193 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Composite Adverse Perinatal Outcome | Placental Abruption | 22 Participants |
p-value: <0.00195% CI: [0.73, 0.92]Chi-squared
95% CI: [0.7, 0.9]
95% CI: [0.6, 0.89]
95% CI: [0.49, 1.64]
95% CI: [0.54, 1.21]
Primary
Small for Gestational Age (Safety)
Birth weight less than 10th percentile for gestational age at birth according to accepted national standard
Time frame: Until delivery
Population: Analysis is restricted to 2270 (1146 in the Treatment Group and 1124 in the Standard Group) who were delivered and who had complete assessments during delivery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Small for Gestational Age (Safety) | 128 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Small for Gestational Age (Safety) | 117 Participants |
p-value: 0.5695% CI: [0.85, 1.36]Chi-squared
Secondary
Adherence to Treatment After Delivery
Counts with high adherence to antihypertensive therapy after delivery for those prescribed medications.
Time frame: 6 weeks (4-12 weeks) after delivery
Population: Analysis is restricted to 706 in Treatment Group and 479 in Standard Group who had complete antihypertensive therapy assessments at the follow-up study visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Adherence to Treatment After Delivery | 436 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Adherence to Treatment After Delivery | 275 Participants |
95% CI: [0.98, 1.18]
Secondary
Composite of Maternal Death or Severe Cardiovascular Morbidity
One or more of maternal death, new heart failure, stroke, encephalopathy, angina, myocardial infarction or ischemia, pulmonary edema, ICU admission/intubation, or renal failure
Time frame: Up to 6 weeks (4-12 weeks) after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Composite of Maternal Death or Severe Cardiovascular Morbidity | 25 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Composite of Maternal Death or Severe Cardiovascular Morbidity | 33 Participants |
95% CI: [0.45, 1.26]
Secondary
Composite of Severe Neonatal Morbidities
One or more of Bronchopulmonary dysplasia (BPD), Retinopathy of prematurity (ROP), Necrotizing enterocolitis (NEC), Intraventricular hemorrhage (VH) grade III/IV
Time frame: Up to 90 days post delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Composite of Severe Neonatal Morbidities | 24 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Composite of Severe Neonatal Morbidities | 31 Participants |
95% CI: [0.45, 1.3]
Secondary
Preterm Birth and Indicated Preterm Birth (<37 Weeks)
Preterm birth and Indicated preterm birth (\<37 weeks) includes any preterm birth less than 37 weeks
Time frame: Until delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Preterm Birth and Indicated Preterm Birth (<37 Weeks) | 332 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Preterm Birth and Indicated Preterm Birth (<37 Weeks) | 377 Participants |
95% CI: [0.77, 0.99]
Secondary
Severe Maternal Hypertension + Components of the Primary Composite Endpoint
Persistent severe hypertension with or without proteinuria + the primary composite
Time frame: Up to 2 weeks postpartum or 90 days for neonatal death
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Severe Maternal Hypertension + Components of the Primary Composite Endpoint | 529 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Severe Maternal Hypertension + Components of the Primary Composite Endpoint | 631 Participants |
95% CI: [0.77, 0.91]
Other Pre-specified
5-min Apgar Score
Incidence (%) with Apgar score \<7 (range 0-10 with lower scores indicating worse outcome)
Time frame: At delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | 5-min Apgar Score | 68 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | 5-min Apgar Score | 80 Participants |
95% CI: [0.62, 1.16]
Other Pre-specified
Blood Transfusion
During pregnancy or postpartum
Time frame: Up to 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Blood Transfusion | 46 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Blood Transfusion | 53 Participants |
95% CI: [0.59, 1.27]
Other Pre-specified
Bradycardia
Prevalence of bradycardia
Time frame: From delivery to hospital discharge (2 - 3 days after delivery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Bradycardia | 31 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Bradycardia | 35 Participants |
95% CI: [0.55, 1.42]
Other Pre-specified
Bronchopulmonary Dysplasia (BPD)
Incidence (%) with bronchopulmonary dysplasia (BPD)
Time frame: Up to 3 months after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Bronchopulmonary Dysplasia (BPD) | 8 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Bronchopulmonary Dysplasia (BPD) | 14 Participants |
95% CI: [0.24, 1.35]
Other Pre-specified
Cesarean Delivery
Cesarean delivery
Time frame: Until delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Cesarean Delivery | 592 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Cesarean Delivery | 582 Participants |
95% CI: [0.93, 1.1]
Other Pre-specified
Head Circumference
Mean head circumference
Time frame: At birth
Population: data incomplete for 84 in the Treated Group and 97 in the Standard Group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Head Circumference | 33.3 cm | Standard Deviation 3 |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Head Circumference | 33.0 cm | Standard Deviation 3 |
95% CI: [0.05, 0.56]
Other Pre-specified
Hospitalizations
Number of hospitalizations before or after delivery
Time frame: Up to 3 months postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Hospitalizations | 0.3 number of encounters | Standard Deviation 0.7 |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Hospitalizations | 0.3 number of encounters | Standard Deviation 0.8 |
95% CI: [-0.1, 0.1]
Other Pre-specified
Hyperbilirubinemia
Incidence (%) with hyperbilirubinemia
Time frame: From delivery to hospital discharge (2 - 3 days after delivery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Hyperbilirubinemia | 266 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Hyperbilirubinemia | 283 Participants |
95% CI: [0.81, 1.08]
Other Pre-specified
Hypoglycemia
Prevalence of hypoglycemia
Time frame: From delivery to hospital discharge (2 - 3 days after delivery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Hypoglycemia | 191 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Hypoglycemia | 195 Participants |
95% CI: [0.81, 1.17]
Other Pre-specified
Hypotension
Incidence (%) with hypotension
Time frame: From delivery to hospital discharge (2 - 3 days after delivery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Hypotension | 7 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Hypotension | 16 Participants |
95% CI: [0.18, 1.05]
Other Pre-specified
Intraventricular Hemorrhage (IVH)
Incidence (%) with any IVH and with IVH Grades III and IV
Time frame: From delivery to hospital discharge (2 - 3 days after delivery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Intraventricular Hemorrhage (IVH) | 11 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Intraventricular Hemorrhage (IVH) | 17 Participants |
95% CI: [0.3, 1.37]
Other Pre-specified
Intubation/Ventilation
Incidence (%) with resuscitation including oxygen, intubation, chest compression/CPR, or CPAP
Time frame: From delivery to hospital discharge (2 - 3 days after delivery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Intubation/Ventilation | 298 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Intubation/Ventilation | 303 Participants |
95% CI: [0.85, 1.12]
Other Pre-specified
Low Birth Weight
Birth weight \<2500g
Time frame: At birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Low Birth Weight | 232 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Low Birth Weight | 277 Participants |
95% CI: [0.71, 0.97]
Other Pre-specified
Necrotizing Enterocolitis (NEC)
Incidence (%) with necrotizing enterocolitis (NEC)
Time frame: Up to 3 months after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Necrotizing Enterocolitis (NEC) | 2 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Necrotizing Enterocolitis (NEC) | 2 Participants |
95% CI: [0.14, 7.06]
Other Pre-specified
Neonatal Hospital Stay of 3 or More Days
Frequency of neonatal hospital stays lasting at least 3 days
Time frame: after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Neonatal Hospital Stay of 3 or More Days | 590 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Neonatal Hospital Stay of 3 or More Days | 592 Participants |
95% CI: [0.9, 1.06]
Other Pre-specified
NICU Admission
Any NICU admission
Time frame: Up to 6 weeks (4-12 weeks) after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | NICU Admission | 368 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | NICU Admission | 402 Participants |
95% CI: [0.81, 1.02]
Other Pre-specified
Placental Weight
Mean placental weight
Time frame: At delivery
Population: data incomplete for 549 in the Treated Group and 562 in the Standard Group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Placental Weight | 466.3 g | Standard Deviation 177.6 |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Placental Weight | 464.6 g | Standard Deviation 175.6 |
95% CI: [-17.6, 20.9]
Other Pre-specified
Ponderal Index
Mean ponderal index, mass/height\^3 at birth
Time frame: At birth
Population: data incomplete for 71 in the Treated Group and 83 in the Standard Group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Ponderal Index | 2.9 g/cm^3 | Standard Deviation 3.7 |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Ponderal Index | 2.7 g/cm^3 | Standard Deviation 2.8 |
95% CI: [-0.11, 0.43]
Other Pre-specified
Postpartum Hospitalizations
Number of postpartum hospitalizations
Time frame: Up to 3 months after delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Postpartum Hospitalizations | 0.15 number of encounters | Standard Deviation 0.44 |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Postpartum Hospitalizations | 0.14 number of encounters | Standard Deviation 0.37 |
95% CI: [-0.02, 0.04]
Other Pre-specified
Postpartum Unscheduled or ER Visits
Number of postpartum unscheduled or ER visits
Time frame: Up to 3 months after delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Postpartum Unscheduled or ER Visits | 0.3 number of encounters | Standard Deviation 0.8 |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Postpartum Unscheduled or ER Visits | 0.4 number of encounters | Standard Deviation 0.8 |
95% CI: [-0.12, 0.002]
Other Pre-specified
Respiratory Distress Syndrome (RDS)
Incidence (%) with respiratory distress syndrome (RDS)
Time frame: From delivery to hospital discharge (2 - 3 days after delivery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Respiratory Distress Syndrome (RDS) | 149 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Respiratory Distress Syndrome (RDS) | 171 Participants |
95% CI: [0.71, 1.06]
Other Pre-specified
Sepsis
Incidence (%) with proven sepsis
Time frame: From delivery to hospital discharge (2 - 3 days after delivery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Sepsis | 21 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Sepsis | 34 Participants |
95% CI: [0.36, 1.05]
Other Pre-specified
Severe Hypertension
Blood pressure ≥160/110
Time frame: Up to 6 weeks (4-12 weeks) after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Severe Hypertension | 436 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Severe Hypertension | 531 Participants |
95% CI: [0.74, 0.9]
Other Pre-specified
Superimposed Gestational Hypertension
Persistent worsening hypertension above baseline without pree or proteinuria occurring after 20 weeks gestation
Time frame: Enrollment (between 6 and 18 weeks gestation) to delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Superimposed Gestational Hypertension | 132 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Superimposed Gestational Hypertension | 156 Participants |
95% CI: [0.68, 1.04]
Other Pre-specified
Superimposed Preeclampsia
Mild or severe, including eclampsia
Time frame: Up to 2 weeks after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Superimposed Preeclampsia | 295 Participants |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Superimposed Preeclampsia | 373 Participants |
95% CI: [0.69, 0.89]
Other Pre-specified
Unscheduled Prenatal Clinic or ER Visits
Number of unscheduled clinic or ER visits before and after delivery
Time frame: Up to 3 months after delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg | Unscheduled Prenatal Clinic or ER Visits | 1.1 number of encounters | Standard Deviation 1.6 |
| No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Unscheduled Prenatal Clinic or ER Visits | 1.2 number of encounters | Standard Deviation 1.6 |
95% CI: [-0.2, 0.03]