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Efficacy of Nifedipine Versus Hydralazine in Management of Severe Hypertension in Pregnancy

NCT04435210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-06-17

No results posted yet for this study

Summary

Introduction - Hypertension is the commonest medical complication of pregnancy. When severe, it puts the lives of both the mother and the unborn baby at risk. Therefore, immediate lowering of blood pressure is indicated whenever this is detected. Different anti-hypertensive drugs are being used to that effect, but more commonly these include: hydralazine, labetalol and nifedipine. Nifedipine, despite being cheap, readily available, safe in pregnancy and easy to administer, is hardly utilized for this purpose in our setting. Hydralazine is usually used instead.

Objectives - This will be: to determine the efficacy of nifedipine and compare it with that of hydralazine, which is more commonly used, and to compare their maternal and fetal side effect profile.

Materials and methods - This will be a prospective randomized controlled open label study of nifedipine versus hydralazine. Patients will be assigned to different arms of the study using computer-generated random numbers. Efficacy and adverse effects of the drugs will be noted on each arm of the study. Data will be collated, tabulated and then statistically analysed using the statistical package for social sciences (SPSS).

Conclusion - The outcome of the study will enable recommendation to be made on the use of nifedipine for severe hypertension if found to be effective.

Conditions

Interventions

DRUG

Hydralazine

Participants in this group will receive 10mg of hydralazine intravenously. This will be repeated every 30 minutes if the blood pressure is equal to or more than 160/110 mmHg after the last dose, up to maximum of five doses.

DRUG

Nifedipine

Participants in this arm will receive 20mg of nifedipine and the blood pressure will be measured 30 minutes after the dose. This will be repeated every 30 minutes if the blood pressure is equal to or more than 160/110 mmHg after the last dose, up to maximum of five doses

Sponsors & Collaborators

  • Adebayo Joshua Adeniyi

    lead OTHER

Principal Investigators

  • Joshua Adebayo, MB;BS, FWACS · Alex Ekwueme Federal University Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-13
Primary Completion
2019-02-09
Completion
2019-02-20

Countries

  • Nigeria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04435210 on ClinicalTrials.gov