AYO TRIA

Not Applicable

• Conditions: Pregnancy and Childbirth

• Registration Number: PACTR201906662822573
• Lead Sponsor: AYO OKWUOSA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

a. All pregnant women with systolic blood pressure of 160mmHg and above, and/or diastolic blood pressure of 110mmHg and above, that persists after 15 minutes.
b.The gestational age of the pregnancy must be beyond the age of viability, which is 28 weeks in the study setting.
c.All pregnant women who give their consent.

Exclusion Criteria

a)All patients who refused to give consent for the study.

b)Any pregnant woman with severe hypertension and seizures, and/ or coma (eclampsia).

c)Any pregnant woman with signs of imminent eclampsia such as: severe headache, blurring of visions, epigastric pain, or reduced urinary output.

d)Any pregnant woman with severe hypertension complicated by abruptio placentae, or cerebrovascular accident.

e)Any pregnant woman with severe hypertension and already established fetal complications, such as: intrauterine growth restriction, or intrauterine fetal death.

f)All pregnant women with other co-morbidities such as; asthma, cardiac disease, diabetes mellitus, and other medical disorders in pregnancy.

g) Any pregnant woman with prior adverse drug reaction to hydralazine and nifedipine.
h)Any pregnant woman with a history of use of any antihypertensive medication within 12 hours of recruitment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The time needed to achieve target blood pressure by both groups (nifedipine and hydralazine)

Secondary Outcome Measures

Name	Time	Method
•Maternal side effects such as headache, nausea and vomiting, hot flushes, palpitations, tachycardia,;•Fetal side effects as fetal heart rate abnormalities;•Maternal complications such as seizures, antepartum haemorrhage, pulmonary oedema, acute kidney injury(reduced urinary output);•Fetal complications : accessed with apgar score especially the fifth minute score;•Route of delivery: vaginal or caesarean section;•The total number of doses of antihypertensives required to achieve target blood pressure;•The need for crossover treatment from one to another, and the use of rescue antihypertensive