Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs

NARecruitingINTERVENTIONAL
Enrollment

264

Participants

Timeline

Start Date

April 10, 2022

Primary Completion Date

November 1, 2025

Study Completion Date

February 1, 2026

Conditions
Threatened Preterm Labor
Interventions
DRUG

Nifedipine 20 Mg

The initial dose of nifedipine will be 2 × 10 mg nifedipine capsules orally in the first hour, followed by 20 mg slow-release nifedipine every 6 hours for the next 47 hours. In the first hour after starting nifedipine, blood pressure and heart rate will be measured every 15 minutes. If blood pressure remains within the normal limits, treatment will be continued.

DRUG

Magnesium sulfate

Women will also receive MgSo4 as a loading dose of MgSo4 will be given immediately after enrollment as 4 gm diluted in 200 mL of saline solution administered intravenous over a period of 20 minutes. Afterwards, the maintenance dose of MgSo4 will be administered intravenous in a dose of 1 gm/hour given as 6 gm diluted in 500 mL saline solution titrated with a rate of 100 mL per hour, then this dose is repeated every 6 hours for 48 hours. Respiratory rate and knee jerk will be assessed hourly for women in the MgSo4 group. Serum magnesium level will be measured if clinically indicated.

Trial Locations (1)

71111

RECRUITING

Assiut University, Asyut

All Listed Sponsors
lead

Assiut University

OTHER