Trial · NCT02299414
Chronic Hypertension and Pregnancy (CHAP) Project
NCT02299414, Phase 4, Completed, University of Alabama at Birmingham; results first posted 2023-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Chronic Hypertension and Pregnancy (CHAP) Project. Trials, record NCT02299414. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02299414
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chronic Hypertension and Pregnancy (CHAP) Project
- NCT number
- NCT02299414
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,408 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Hypertension
- Interventions
- Anti-hypertensive therapy, No anti-hypertensive therapy (unless BP is severe)
- First posted
- 2014-11-24
- Last updated
- 2023-05-17
- Results first posted
- 2023-05-17
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). |
| Primary | Small for Gestational Age (Safety) | Until delivery | Birth weight less than 10th percentile for gestational age at birth according to accepted national standard |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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. |
| Other | Superimposed Preeclampsia | Up to 2 weeks after delivery | Mild or severe, including eclampsia |
| Other | 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 |
| Other | Severe Hypertension | Up to 6 weeks (4-12 weeks) after delivery | Blood pressure ≥160/110 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Adverse Perinatal Outcome | Up to 2 weeks postpartum for preeclampsia or 90 days for neonatal death | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Small for Gestational Age (Safety) | Until delivery | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Composite of Maternal Death or Severe Cardiovascular Morbidity | Up to 6 weeks (4-12 weeks) after delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Severe Maternal Hypertension + Components of the Primary Composite Endpoint | Up to 2 weeks postpartum or 90 days for neonatal death | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Preterm Birth and Indicated Preterm Birth (<37 Weeks) | Until delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Composite of Severe Neonatal Morbidities | Up to 90 days post delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adherence to Treatment After Delivery | 6 weeks (4-12 weeks) after delivery | 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. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Superimposed Preeclampsia | Up to 2 weeks after delivery | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Superimposed Gestational Hypertension | Enrollment (between 6 and 18 weeks gestation) to delivery | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Severe Hypertension | Up to 6 weeks (4-12 weeks) after delivery | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Adverse Perinatal Outcome | Anti-hypertensive Therapy to Goal <140/90 mmHg | Composite Primary Outcome | 353 | Participants | |
| Composite Adverse Perinatal Outcome | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Composite Primary Outcome | 427 | Participants | |
| Composite Adverse Perinatal Outcome | Anti-hypertensive Therapy to Goal <140/90 mmHg | Preeclampsia with Severe Features | 272 | Participants | |
| Composite Adverse Perinatal Outcome | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Preeclampsia with Severe Features | 336 | Participants | |
| Composite Adverse Perinatal Outcome | Anti-hypertensive Therapy to Goal <140/90 mmHg | Indicated Preterm Birth <35 weeks | 143 | Participants | |
| Composite Adverse Perinatal Outcome | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Indicated Preterm Birth <35 weeks | 193 | Participants | |
| Composite Adverse Perinatal Outcome | Anti-hypertensive Therapy to Goal <140/90 mmHg | Placental Abruption | 20 | Participants | |
| Composite Adverse Perinatal Outcome | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Placental Abruption | 22 | Participants | |
| Composite Adverse Perinatal Outcome | Anti-hypertensive Therapy to Goal <140/90 mmHg | Fetal or Neonatal Death <28 days | 41 | Participants | |
| Composite Adverse Perinatal Outcome | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | Fetal or Neonatal Death <28 days | 50 | Participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anti-hypertensive Therapy to Goal <140/90 mmHg | 1,208 | |
| Overall Study | STARTED | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | 1,200 | |
| Overall Study | COMPLETED | Anti-hypertensive Therapy to Goal <140/90 mmHg | 1,208 | |
| Overall Study | COMPLETED | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | 1,200 | |
| Overall Study | NOT COMPLETED | Anti-hypertensive Therapy to Goal <140/90 mmHg | 0 | |
| Overall Study | NOT COMPLETED | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | 0 |
Source ClinicalTrials.gov
Adverse events210
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Anti-hypertensive Therapy to Goal <140/90 mmHg | 3 | 1,208 | 3 |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | 0 | 1,200 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | Anti-hypertensive Therapy to Goal <140/90 mmHg | 0 | 1,208 | 0 |
| serious | Anaemia | Blood and lymphatic system disorders | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | 1 | 1,200 | 1 |
| serious | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Anti-hypertensive Therapy to Goal <140/90 mmHg | 1 | 1,208 | 1 |
| serious | Disseminated intravascular coagulation | Blood and lymphatic system disorders | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | 1 | 1,200 | 1 |
| serious | Foetal anaemia | Blood and lymphatic system disorders | Anti-hypertensive Therapy to Goal <140/90 mmHg | 1 | 1,208 | 1 |
| serious | Foetal anaemia | Blood and lymphatic system disorders | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | 0 | 1,200 | 0 |
| serious | Foetal Death | Pregnancy, puerperium and perinatal conditions | Anti-hypertensive Therapy to Goal <140/90 mmHg | 36 | 1,208 | 36 |
| serious | Foetal Death | Pregnancy, puerperium and perinatal conditions | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | 42 | 1,200 | 42 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anti-hypertensive Therapy to Goal <140/90 mmHg | 42 | 1,208 |
| Total, all-cause mortality | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | 52 | 1,200 |
| Total, other adverse events | Anti-hypertensive Therapy to Goal <140/90 mmHg | 0 | 1,208 |
| Total, other adverse events | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | 0 | 1,200 |
| Total, serious adverse events | Anti-hypertensive Therapy to Goal <140/90 mmHg | 113 | 1,208 |
| Total, serious adverse events | No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg | 126 | 1,200 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HL119242 | Chronic Hypertension and Pregnancy (CHAP): Data Coordinating Center | SZYCHOWSKI, JEFF M | UNIVERSITY OF ALABAMA AT BIRMINGHAM | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2014 to 2020 |
Source NIH RePORTER
Trial comparisons27
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Anti-hypertensive Therapy to Goal <140/90 mmHg vs No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg: Superimposed Preeclampsia | Trial comparisons |
| Anti-hypertensive Therapy to Goal <140/90 mmHg vs No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg: Neonatal Hospital Stay of 3 or More Days | Trial comparisons |
| Anti-hypertensive Therapy to Goal <140/90 mmHg vs No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg: Hypoglycemia | Trial comparisons |
| Anti-hypertensive Therapy to Goal <140/90 mmHg vs No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg: Low Birth Weight | Trial comparisons |
| Anti-hypertensive Therapy to Goal <140/90 mmHg vs No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg: Bronchopulmonary Dysplasia (BPD) | Trial comparisons |
| Anti-hypertensive Therapy to Goal <140/90 mmHg vs No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg: 5-min Apgar Score | Trial comparisons |
| Anti-hypertensive Therapy to Goal <140/90 mmHg vs No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg: Adherence to Treatment After Delivery | Trial comparisons |
| Anti-hypertensive Therapy to Goal <140/90 mmHg vs No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg: Superimposed Gestational Hypertension | Trial comparisons |
| Anti-hypertensive Therapy to Goal <140/90 mmHg vs No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg: Bradycardia | Trial comparisons |
| Anti-hypertensive Therapy to Goal <140/90 mmHg vs No Anti-hypertensive Unless BP is Severe (≥160/105 mmHg: Necrotizing Enterocolitis (NEC) | Trial comparisons |
1 to 10 of 27
See all 27 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02299414
GET https://conductscience.org/api/trials/v1/NCT02299414/registered?page=2