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AYO TRIAL

Oral immediate-release nifedipine versus parenteral hydralazine for controlling severe hypertension in pregnancy: a double-blind randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201906662822573
Enrollment
70
Registered
2019-06-19
Start date
2019-06-12
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and Childbirth

Interventions

immediate release nifedipine
Hydralazine group

Sponsors

AYO OKWUOSA
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The time needed to achieve target blood pressure by both groups (nifedipine and hydralazine)

Secondary

MeasureTime frame
• 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;• 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

Countries

Nigeria

Contacts

Public ContactOKAY IKPEZE

PROFESSOR

ocikpeze@yahoo.com+2348167624145

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026