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Clinical Trial Summary

Objective: This trial is designed to compare between the effectiveness of nifedipine versus magnesium sulfate (MgSO4) for tocolysis in women with threatened preterm labor. Patient Population: The population will include pregnant women at gestational age between 32 and 36 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 32 and 36 weeks having threatened preterm labor will be enrolled and randomized into two parallel treatment arms. Patients in the group A will receive nifedipine, 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

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Study Design


Related Conditions & MeSH terms


NCT number NCT05343806
Study type Interventional
Source Assiut University
Contact Karim Abdallah, MD
Phone +201270595485
Email karimsayed88@aun.edu.eg
Status Recruiting
Phase N/A
Start date March 1, 2023
Completion date February 1, 2026

See also
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Withdrawn NCT01314859 - Nifedipine Treatment in Preterm Labor Phase 3
Completed NCT01773135 - Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor N/A
Recruiting NCT05477381 - Cervical Softening and the Prediction of Preterm Birth
Recruiting NCT04374916 - Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor N/A
Recruiting NCT05345132 - Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs N/A