Hypertension in PregnancyPhase 4NCT01912677
Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy
A Phase 4 study testing Nifedipine, Labetalol and Methyldopa in people with Hypertension in Pregnancy and Preeclampsia, run by Gynuity Health Projects at 2 sites in India.
Trial summary
This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive regimens for women with severe hypertension in pregnancy. Women presenting with severe hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of three oral regimens: nifedipine, labetalol or… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hypertension in Pregnancy, Preeclampsia
- What is being tested?
- Nifedipine, Labetalol and Methyldopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 894 participants
- Where
- 2 sitesIndia
- Study dates
- Apr 2015to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant gestational age >= 28 weeks
- Systolic blood pressure >=160 mm Hg OR a diastolic blood pressure of >=110 mm Hg measured twice more than 15 minutes apart
- Able to swallow pills
- >= 18 years
Who cannot join
- Indication for emergent cesarean or known fetal anomaly
- Anti-hypertensive therapy received in the past 12 hours
- History of eclampsia or other adverse CNS complication (e.g., stroke or PRES) in this pregnancy
- Actively wheezing at time of enrollment or history of asthma complications
- Known coronary artery disease or type I DM with microvascular complications or signs of heart failure or clinical dissection of the aorta
Trial locations and contacts
2 sites in 1 country.
India2 sites
Daga Women's Hospital
Nagpur, Maharashtra, 440003
Government Medical College
Nagpur, Maharashtra, 440003
About this study
This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive regimens for women with severe hypertension in pregnancy. Women presenting with severe hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the efficacy, safety and side effects of these three oral regimens for management of hypertension in pregnant women. The investigators hypothesize that nifedipine treatment of severe hypertensive parturient women is more effective than treatment with labetalol or methyldopa in controlling high blood pressure within six hours.
Read the detailed description
This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive regimens for women with severe hypertension in pregnancy. Women presenting with severe hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the efficacy, safety and side effects of these three oral regimens for management of hypertension in pregnant women. The investigators hypothesize that nifedipine treatment of severe hypertensive parturient women is more effective than treatment with labetalol or methyldopa in controlling high blood pressure within six hours.
- Conditions
- Hypertension in Pregnancy, Preeclampsia
- Being tested
- Nifedipine, Labetalol, Methyldopa
- Keywords
- hypertension in pregnancy, preeclampsia, anti-hypertension, labetalol, nifedipine, methyldopa
- 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
LabetalolDrug
MethyldopaDrug
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine | Active comparator | Women will receive an initial dose of oral nifedipine 10mg. If blood pressure exceeds 155mmHg systolic OR 105 mmHg diastolic after 1h, an additional 10mg dose can be provided each hour for two additional doses (30 mg total). Receives: Drug: Nifedipine |
| Methyldopa | Experimental | Women will receive an initial dose of oral methyldopa 1000mg. No additional escalation in dose in the first 6 hours will be given. Receives: Drug: Methyldopa |
| Labetalol | Experimental | Women will receive an initial dose of oral labetalol 200mg. If blood pressure exceeds 155mmHg systolic OR 105 mmHg diastolic after 1h, an additional 200mg dose can be provided each hour for two additional doses (600 mg total). Receives: Drug: Labetalol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful outcome
Successful outcome will be considered blood pressure that reaches the target (defined as 120-150mmHg systolic and 70-100 mmHg mm Hg diastolic) at 6h without an adverse outcome.
Measured: 6 hours
Secondary outcomes (1)
number of hourly BP's in severe range
the number of hourly BP's in severe range
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startApr 2015
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 894 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Government Medical College, Nagpur, Daga Memorial Women's Hospital, Nagpur, India, University of British Columbia, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Hillary Bracken, PhD, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912677
- Sponsor's protocol ID
- 4000
- Status last verified
- Nov 2018
- First submitted
- 29 Jul 2013
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Easterling T, Mundle S, Bracken H, Parvekar S, Mool S, Magee LA, von Dadelszen P, Shochet T, Winikoff B. Oral antihypertensive regimens (nifedipine retard, labetalol, and methyldopa) for management of severe hypertension in pregnancy: an open-label, randomised controlled trial. Lancet. 2019 Sep 21;394(10203):1011-1021. doi: 10.1016/S0140-6736(19)31282-6. Epub 2019 Aug 1.
PubMed 31378394
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy
- ClinicalTrials.gov ID
- NCT01912677
- Acronym / sponsor ID
- 4000
- Conditions
- Hypertension in Pregnancy, Preeclampsia
- Keywords
- hypertension in pregnancy, preeclampsia, anti-hypertension, labetalol, nifedipine, methyldopa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 894 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Government Medical College, Nagpur, Daga Memorial Women's Hospital, Nagpur, India, University of British Columbia, Bill and Melinda Gates Foundation
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive regimens for women with severe hypertension in pregnancy. Women presenting with severe hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the efficacy, safety and side effects of these three oral regimens for management of hypertension in pregnant women. The investigators hypothesize that nifedipine treatment of severe hypertensive parturient women is more effective than treatment with labetalol or methyldopa in controlling high blood pressure within six hours.
Detailed description
This is a pragmatic, open-label, randomised control trial of three oral anti-hypertensive regimens for women with severe hypertension in pregnancy. Women presenting with severe hypertension in pregnancy in two hospitals in Nagpur, India will be randomised to one of three oral regimens: nifedipine, labetalol or methyldopa. This trial will compare the efficacy, safety and side effects of these three oral regimens for management of hypertension in pregnant women. The investigators hypothesize that nifedipine treatment of severe hypertensive parturient women is more effective than treatment with labetalol or methyldopa in controlling high blood pressure within six hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nifedipine | Active comparator | Drug: NifedipineWomen will receive an initial dose of oral nifedipine 10mg. If blood pressure exceeds 155mmHg systolic OR 105 mmHg diastolic after 1h, an additional 10mg dose can be provided each hour for two additional doses (30 mg total). |
| Methyldopa | Experimental | Drug: MethyldopaWomen will receive an initial dose of oral methyldopa 1000mg. No additional escalation in dose in the first 6 hours will be given. |
| Labetalol | Experimental | Drug: LabetalolWomen will receive an initial dose of oral labetalol 200mg. If blood pressure exceeds 155mmHg systolic OR 105 mmHg diastolic after 1h, an additional 200mg dose can be provided each hour for two additional doses (600 mg total). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant gestational age >= 28 weeks
- Systolic blood pressure >=160 mm Hg OR a diastolic blood pressure of >=110 mm Hg measured twice more than 15 minutes apart
- Able to swallow pills
- >= 18 years
Key exclusion criteria (5 listed)
- Indication for emergent cesarean or known fetal anomaly
- Anti-hypertensive therapy received in the past 12 hours
- History of eclampsia or other adverse CNS complication (e.g., stroke or PRES) in this pregnancy
- Actively wheezing at time of enrollment or history of asthma complications
- Known coronary artery disease or type I DM with microvascular complications or signs of heart failure or clinical dissection of the aorta
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 |
|---|---|---|
| Nifedipine | Drug | Nifedipine |
| Labetalol | Drug | Labetalol |
| Methyldopa | Drug | Methyldopa |
Primary outcome
Successful outcome
Time frame: 6 hours
Successful outcome will be considered blood pressure that reaches the target (defined as 120-150mmHg systolic and 70-100 mmHg mm Hg diastolic) at 6h without an adverse outcome.
1 secondary outcome
number of hourly BP's in severe range
Time frame: one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Derived from this study: PubMed 31378394Easterling T, Mundle S, Bracken H, Parvekar S, Mool S, Magee LA, von Dadelszen P, Shochet T, Winikoff B. Oral antihypertensive regimens (nifedipine retard, labetalol, and methyldopa) for management of severe hypertension in pregnancy: an open-label, randomised controlled trial. Lancet. 2019 Sep 21;394(10203):1011-1021. doi: 10.1016/S0140-6736(19)31282-6. Epub 2019 Aug 1.
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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.
Hillary Bracken, PhD principal investigator
Gynuity Health Projects
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, Labetalol and Methyldopa in people with Hypertension in Pregnancy and Preeclampsia, run by Gynuity Health Projects at 2 sites in India.
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 4 inclusion and 5 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 8 Nov 2018. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Successful outcome (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01912677, which also lists 1 linked publication.
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 8 Nov 2018.