Hypertension in PregnancyPhase 4NCT03506724
Response to Anti-hypertensives in Pregnant and Postpartum Patients
A Phase 4 study testing Nifedipine and Labetalol in people with Hypertension in Pregnancy and Preeclampsia, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
In this study, the investigators will evaluate the blood pressure response to nifedipine and labetalol in pregnant and postpartum patients, who present with hypertensive disease in pregnancy with severe range blood pressure defined as greater than 160/110. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension in Pregnancy, Preeclampsia
- What is being tested?
- Nifedipine and Labetalol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2017to 5 Apr 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant patients from 20 weeks to up to 6 weeks postpartum
- between the ages of 18-55.
- persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic.
Who cannot join
- multiple gestation
- patients with non-reassuring fetal heart rate (category 3)
- patients with abruptio placenta
- patients with renal impairment
- history of heart failure
- history of cardiac arrhythmia
- use of anti-hypertensive medications in the past 24 hours
- patients with allergies or medical contraindications to labetalol or nifedipine.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Maimonides Hospital
Brooklyn, New York, 11219
Mount Sinai West
New York, New York, 10019
About this study
Official title: Ethnic Differences in Anti-Hypertensive Medication Response Among Pregnant and Postpartum Patients
In this study, the investigators will evaluate the blood pressure response to nifedipine and labetalol in pregnant and postpartum patients, who present with hypertensive disease in pregnancy with severe range blood pressure defined as greater than 160/110. These anti-hypertensives are first line therapy for management of severe range blood pressures in pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG). In addition at the Mount Sinai West site, the investigators will also analyze the ADRB1 and similar genes involved in beta blockade, genes involved in calcium channel blockade and other genes implicated in blood pressure response among pregnant and postpartum patients receiving labetalol and nifedipine. This analysis will be used to determine if a pharmacogenetic association exists between variant alleles in these receptors in the pregnant and postpartum population.
Read the detailed description
Hypertensive disease in pregnancy is a major cause of maternal morbidity and mortality. This condition is responsible for about 12% of the maternal deaths in the United States.
Currently, if pregnant patients present with severe hypertension they are either given IV labetalol, IV hydralazine of nifedipine based on individual provider preference. There are few studies in the literature comparing oral nifedipine and IV labetalol with mixed data showing either they are equally effective or a faster time to achieving target blood pressure for patients who received nifedipine.
In this study, the investigators will evaluate if there is a difference in time to achieve goal blood pressure in pregnant and postpartum patients who are treated with nifedipine and labetalol for severe range blood pressures defined as greater than 160/110. These anti-hypertensives are first line therapy for management of severe range blood pressures in pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG).
- Conditions
- Hypertension in Pregnancy, Preeclampsia
- Being tested
- Nifedipine, Labetalol
- Keywords
- Hypertension, Pregnancy-induced, Pregnancy Induced Hypertension, Gestational Hypertension, Transient Hypertension, Pregnancy, Pharmacogenetics
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NifedipineDrug
Nifedipine 10mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given and institution specific protocol will be performed.
LabetalolDrug
Labetalol 20mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication will be chosen based on institution specific protocol.
| Study group | Role | What they receive |
|---|---|---|
| Oral nifedipine | Other | Oral medication 10mg and 20mg Receives: Drug: Nifedipine |
| Intravenous labetalol | Other | intravenous medication 20mg, 40mg, 80 mg Receives: Drug: Labetalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Achieve Non Severe Range Blood Pressure
Time to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
Measured: Ten minute intervals from the time of the first severe range blood pressure, up to 1 hour
Number of Participants to Achieve Non Severe Range Blood Pressure
Number of participants by ethnicity to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
Measured: up to 1 hour
Secondary outcomes (2)
Frequency of Genetic Variants of Genes
the frequency of variant alleles in different receptors involved in the response to labetalol and nifedipine administration in the pregnant and postpartum population.
Measured: up to 1 year
Number of Participants With Medication Side Effects
Number of participants with side effect profile to assess the rate of side effects from IV labetalol and oral nifedipine
Measured: assessed 10 minutes to 1 hour after medication is given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start11 Sep 2017
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who present to the hospitals in this study will be randomized to receive IV labetalol or oral nifedipine when presenting with persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic. These anti-hypertensives are first line therapy for management of severe range blood pressures by the American Congress of Obstetricians and Gynecologists.
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, New York, Maimonides Medical Center
- Responsible party
- Principal investigator, Dyese Taylor, Icahn School of Medicine at Mount Sinai
- Investigators
- Lois Brustman, MD, Study director, Icahn School of Medicine at Mount SinaiHoward Minkoff, MD, Study director, Icahn School of Medicine at Mount SinaiPoroshat Shekarloo, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506724
- Sponsor's protocol ID
- GCO 17-0257
- Other IDs
- Maimonides IRB 2018-02-17
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2018
- Last updated
- 24 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnic Differences in Anti-Hypertensive Medication Response Among Pregnant and Postpartum Patients
- ClinicalTrials.gov ID
- NCT03506724
- Acronym / sponsor ID
- GCO 17-0257
- Conditions
- Hypertension in Pregnancy, Preeclampsia
- Keywords
- Hypertension, Pregnancy-induced, Pregnancy Induced Hypertension, Gestational Hypertension, Transient Hypertension, Pregnancy, Pharmacogenetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, New York, Maimonides Medical Center
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Posted 24 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will evaluate the blood pressure response to nifedipine and labetalol in pregnant and postpartum patients, who present with hypertensive disease in pregnancy with severe range blood pressure defined as greater than 160/110. These anti-hypertensives are first line therapy for management of severe range blood pressures in pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG). In addition at the Mount Sinai West site, the investigators will also analyze the ADRB1 and similar genes involved in beta blockade, genes involved in calcium channel blockade and other genes implicated in blood pressure response among pregnant and postpartum patients receiving labetalol and nifedipine. This analysis will be used to determine if a pharmacogenetic association exists between variant alleles in these receptors in the pregnant and postpartum population.
Detailed description
Hypertensive disease in pregnancy is a major cause of maternal morbidity and mortality. This condition is responsible for about 12% of the maternal deaths in the United States.
Currently, if pregnant patients present with severe hypertension they are either given IV labetalol, IV hydralazine of nifedipine based on individual provider preference. There are few studies in the literature comparing oral nifedipine and IV labetalol with mixed data showing either they are equally effective or a faster time to achieving target blood pressure for patients who received nifedipine.
In this study, the investigators will evaluate if there is a difference in time to achieve goal blood pressure in pregnant and postpartum patients who are treated with nifedipine and labetalol for severe range blood pressures defined as greater than 160/110. These anti-hypertensives are first line therapy for management of severe range blood pressures in pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients who present to the hospitals in this study will be randomized to receive IV labetalol or oral nifedipine when presenting with persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic. These anti-hypertensives are first line therapy for management of severe range blood pressures by the American Congress of Obstetricians and Gynecologists.
| Arm | Type | Receives |
|---|---|---|
| Oral nifedipine | Other | Drug: NifedipineOral medication 10mg and 20mg |
| Intravenous labetalol | Other | Drug: Labetalolintravenous medication 20mg, 40mg, 80 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pregnant patients from 20 weeks to up to 6 weeks postpartum
- between the ages of 18-55.
- persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic.
Key exclusion criteria (8 listed)
- multiple gestation
- patients with non-reassuring fetal heart rate (category 3)
- patients with abruptio placenta
- patients with renal impairment
- history of heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NifedipineNifedipine 10mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given and institution specific protocol will be performed. | Drug | Oral nifedipine |
| LabetalolLabetalol 20mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication will be chosen based on institution specific protocol. | Drug | Intravenous labetalol |
Primary outcome
Time to Achieve Non Severe Range Blood Pressure
Time frame: Ten minute intervals from the time of the first severe range blood pressure, up to 1 hour
Time to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
Number of Participants to Achieve Non Severe Range Blood Pressure
Time frame: up to 1 hour
Number of participants by ethnicity to achieve goal blood pressure, that is, non severe range blood pressures after medication received.
2 secondary outcomes
Frequency of Genetic Variants of Genes
Time frame: up to 1 year
Number of Participants With Medication Side Effects
Time frame: assessed 10 minutes to 1 hour after medication is given
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lois Brustman, MD study director
Icahn School of Medicine at Mount Sinai
Howard Minkoff, MD study director
Icahn School of Medicine at Mount Sinai
Poroshat Shekarloo, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nifedipine and Labetalol in people with Hypertension in Pregnancy and Preeclampsia, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Achieve Non Severe Range Blood Pressure (time frame: Ten minute intervals from the time of the first severe range blood pressure, up to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.