Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs — ASTOS1  

Threatened Preterm Labor Clinical Trial

Official title: Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate Alone for Tocolysis in Pregnant Women at 28 - 31 Weeks Gestation With Threatened Preterm Labor

Status Recruiting

Clinical Trial Summary

Objective: This trial is designed to compare between the effectiveness of nifedipine plus magnesium sulfate (MgSO4) and MgSO4 alone for tocolysis in women with threatened preterm labor.

Patient Population: The population will include pregnant women at gestational age between 28 and 31 weeks who are 18 years old or older and have signs of threatened preterm labor.

Study Design: This is a single-center, prospective, randomized controlled clinical trial. A total of 264 women pregnant between 28 and 31 weeks having threatened preterm labor will be enrolled and randomized into two parallel treatment arms. Patients in the group A will receive nifedipine plus MgSO4, while patients in group B will MgSO4 only.

Treatment: All patients will be randomized on the day of enrollment. Patients with threatened preterm labor will receive the respective tocolysis in each group. All patients will receive corticosteroids for lung maturity according to the local protocol.

Primary outcome: Number of women not delivered within 48 hours of starting tocolytic therapy.

Secondary outcomes: perinatal mortality, a composite of adverse neonatal outcomes, birth weight, days on ventilation support, length of admission in neonatal intensive care, prolongation of pregnancy more than 7 days, delivery after 37 weeks of gestation, number of days till delivery, maternal mortality, maternal infection, and harm to mother from intervention.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Threatened Preterm Labor

• NCT number: NCT05345132
• Study type: Interventional
• Source: Assiut University
• Contact: Karim S Abdallah, MD
• Phone: +201270595485
• Email: karimsayed88@aun.edu.eg
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2022
• Completion date: February 1, 2026