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| Name | Class |
|---|---|
| Government Medical College, Nagpur | INDUSTRY |
| Daga Memorial Women's Hospital, Nagpur, India | OTHER |
| University of British Columbia | OTHER |
| Bill and Melinda Gates Foundation |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine | Drug |
| ||
| Labetalol |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| number of hourly BP's in severe range | the number of hourly BP's in severe range | one hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Bracken, PhD | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daga Women's Hospital | Nagpur | Maharashtra | 440003 | India | ||
| Government Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31378394 | Derived | 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. |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| D007741 | Labetalol |
| D008750 | Methyldopa |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| OTHER |
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|
| Methyldopa | Drug |
|
| Nagpur |
| Maharashtra |
| 440003 |
| India |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004983 |
| Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D012457 | Salicylamides |
| D000577 | Amides |
| D000588 | Amines |
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |