NCT01912677

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
894

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2015

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

2.4 years

First QC Date

July 29, 2013

Last Update Submit

November 6, 2018

Conditions

Hypertension in PregnancyPreeclampsia

Keywords

hypertension in pregnancypreeclampsiaanti-hypertensionlabetalolnifedipinemethyldopa

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • number of hourly BP's in severe range

    one hour

Study Arms (3)

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).

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.

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).

Drug: Labetalol

Interventions

NifedipineDRUG
Nifedipine
LabetalolDRUG
Labetalol
MethyldopaDRUG
Methyldopa

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Daga Women's Hospital

Nagpur, Maharashtra, 440003, India

Location

Government Medical College

Nagpur, Maharashtra, 440003, India

Location

Related Publications (1)

  • 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.

    PMID: 31378394DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedPre-Eclampsia

Interventions

NifedipineLabetalolMethyldopa

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsSalicylamidesAmidesAminesDihydroxyphenylalanineCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Officials

  • Hillary Bracken, PhD

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

July 31, 2013

Study Start

April 1, 2015

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

November 8, 2018

Record last verified: 2018-11

Locations

IN(2)