A comparative study of oral nifedipine versus intravenous labetalol for controlling severe hypertension in pregnancy: a randomized controlled trial in Ilorin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202503835469014

Enrollment

Registered

2025-03-19

Start date

2025-04-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

severe hypertension in pregnancy

Interventions

intravenous labetalol

Oral Nipedipine

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Consenting pregnant women with viable fetus at estimated gestational age =28 weeks with systolic BP=160mmHg and/or diastolic BP=110mmHg measured on 2 occasions 15 minutes apart, which a decision has been made to terminate the pregnancy.

Exclusion criteria

Exclusion criteria: 1. History of allergy to nifedipine and/or labetalol. 2. Maternal heart rate 120beats per minute 3. History of heart rhythm abnormality 4. Women who cannot take oral medication 5. Active phase of labour 6. Chronic medical disorders including asthma, chronic liver disease, congestive heart failure and cardiac disease in pregnancy 7. Eclampsia 8. Patient who declines participation in the study

Design outcomes

Primary

Measure	Time frame
The time taken and the minimum number of doses of antihypertensive required to attain target blood pressure (systolic blood pressure 120-150 mmHg and diastolic blood pressure 70-100 mmHg)	—

Secondary

Measure	Time frame
1. Agent failure (refers to a condition in which a patient's blood pressure remains elevated above the desired target level, even after taking at least five doses of the trial drug) 2. The occurrence of significant side effects associated with drug administration (nausea, vomiting, diarrhea, headaches, flushing, dizziness, muscle/joint pains, palpitations, shortness of breath, chest pain, paresthesia, skin rash, pruritus, tachycardia, bradycardia and hypotension). 3. Urine output. 4. Maternal outcomes (absence of further complications, eclampsia, acute pulmonary edema, hemolytic anemia, acute kidney injury, HELLP syndrome, disseminated intravascular coagulopathy, cerebrovascular accident and placental abruption). 5. Perinatal outcomes (fetal demise, preterm delivery, first and fifth-minute APGAR scores, low birth weight, admission to the neonatal intensive care unit and early neonatal death)	—

Measure

Time frame

1. Agent failure (refers to a condition in which a patient's blood pressure remains elevated above the desired target level, even after taking at least five doses of the trial drug) 2. The occurrence of significant side effects associated with drug administration (nausea, vomiting, diarrhea, headaches, flushing, dizziness, muscle/joint pains, palpitations, shortness of breath, chest pain, paresthesia, skin rash, pruritus, tachycardia, bradycardia and hypotension). 3. Urine output. 4. Maternal outcomes (absence of further complications, eclampsia, acute pulmonary edema, hemolytic anemia, acute kidney injury, HELLP syndrome, disseminated intravascular coagulopathy, cerebrovascular accident and placental abruption). 5. Perinatal outcomes (fetal demise, preterm delivery, first and fifth-minute APGAR scores, low birth weight, admission to the neonatal intensive care unit and early neonatal death)

—

Countries

Nigeria

Contacts

Public ContactBashir Halimi

Supervisor

drbashir.halimi@gmail.com+2348033727790

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026