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

NCT04435210 | Completed

• 1 other identifier: FETHA/REC/VOL1/2017/590
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension

Keywords

Hypertension; Pregnancy; Nifedipine; Hydralazine

Outcome Measures

Primary Outcomes (1)

• Number of drug doses

  Number of doses of the drug needed to achieve targeted blood pressure

  24 hours after the first dose

Secondary Outcomes (7)

• Number of patients with side effects

  24 hours after the first dose

• Number of fetuses with fetal heart rate irregularity

  Before delivery

• Number of live birth and stillbirth

  At birth

• Mean birth weight

  Through study completion, an average of six months

• APGAR score

  At birth

Study Arms (2)

Nifedipine arm

EXPERIMENTAL

Participants in this arm will be pregnant women with severe hypertension who will receive nifedipine

Drug: Nifedipine

Hydralazine

EXPERIMENTAL

Participants in this arm will be pregnant women with severe hypertension who will receive hydralazine

Drug: Hydralazine

Interventions

Hydralazine DRUG

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.

Hydralazine

Nifedipine DRUG

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

Nifedipine arm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with singleton pregnancy
• Gestational age of 28 weeks and above
• Severe hypertension in pregnancy

You may not qualify if:

• Patients who do not consent to the study
• Unconscious patients
• Complications of hypertension in pregnancy such as cerebrovascular accident, severe renal impairment and heart disease
• Multiple gestation
• Gestational ages below 28 weeks

Sponsors & Collaborators

• Adebayo Joshua Adeniyi: lead

Study Sites (1)

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 840001, Nigeria

Location

Related Publications (1)

• Adebayo JA, Nwafor JI, Lawani LO, Esike CO, Olaleye AA, Adiele NA. Efficacy of nifedipine versus hydralazine in the management of severe hypertension in pregnancy: A randomised controlled trial. Niger Postgrad Med J. 2020 Oct-Dec;27(4):317-324. doi: 10.4103/npmj.npmj_275_20.

  PMID: 33154284 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Hydralazine; Nifedipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phthalazines; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines

Study Officials

• Joshua Adebayo, MB;BS, FWACS

  Alex Ekwueme Federal University Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor, Senior Registrar, Department of Obstetrics and Gynaecology, Principal Investigator

Model Details: The participants in the study will be randomized into two study groups in ratio 1:1. One of the study groups will receive 20mg of oral nifedipine while the other arm will receive 10mg of intravenous hydralazine. Each dose is to be repeated after 30 minutes if the blood pressure is equal to or greater than 160/110 mmHg.

Study Record Dates

• First Submitted: May 24, 2020
• First Posted: June 17, 2020
• Study Start: August 13, 2018
• Primary Completion: February 9, 2019
• Study Completion: February 20, 2019
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Within 10 years after publication of the manuscript
• Access Criteria: On request

Locations

NG (1)