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Search / Trial NCT05343806

Nifedipine Versus Magnesium Sulfate for Late Preterm Tocolysis

Launched by ASSIUT UNIVERSITY · Apr 19, 2022

Trial Information

Current as of November 13, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at two medications, nifedipine and magnesium sulfate (MgSO4), to see which one is better at helping pregnant women who are at risk of delivering their babies early, a condition known as threatened preterm labor. Specifically, the study will include women who are between 32 and 36 weeks pregnant and experiencing signs of early labor, such as frequent contractions. Participants will be randomly assigned to receive either nifedipine or magnesium sulfate, and both groups will also receive treatment to help their baby's lungs mature.

To be eligible for this trial, women must be 18 years or older and have specific signs of threatened preterm labor. However, certain conditions, like serious heart problems or infections, may prevent some women from participating. Throughout the study, women can expect to receive close monitoring and care as they receive their assigned treatment. Overall, the goal is to determine which medication is more effective in delaying delivery for these women, which is crucial for the health of both the mother and the baby.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Pregnant women with threatened preterm labor defined as 3 or more uterine contractions in 30 minutes confirmed by cardiotocography.
  • 2. Gestational age from 32 week + 0 days to (inclusive) 36 weeks + 0 days.
  • 3. Women with singleton or multiple pregnancy.
  • 4. Women with preterm prelabor rupture of membranes (PROM) will be included if they have uterine contractions.
  • Exclusion Criteria:
  • 1. Contraindications for the use of either drugs, such as cardiac disease, hypotension, myasthenia gravis, or renal impairment.
  • 2. Contraindications for tocolysis, such as intrauterine demise, intrauterine infection, fetal distress, placental separation, or severe pre-eclampsia.
  • 3. Cervical dilatation \> 5 cm.
  • 4. Cervical length \> 30 mm by trans-vaginal ultrasound.
  • 5. Cervical cerclage.

About Assiut University

Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.

Locations

Assiut, Egypt

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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