Status:

RECRUITING

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

Lead Sponsor:

Assiut University

Conditions:

Threatened Preterm Labor

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief 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 Popul...

Eligibility Criteria

Inclusion

  • Pregnant women with threatened preterm labor defined as 3 or more uterine contractions in 30 minutes confirmed by cardiotocography.
  • Gestational age from 28 week + 0 days to (inclusive) 31 weeks + 6 days.
  • Women with singleton or multiple pregnancy.
  • Women with preterm prelabor rupture of membranes (PROM) will be included if they have uterine contractions.

Exclusion

  • Contraindications for the use of either drugs, such as cardiac disease, hypotension, myasthenia gravis, or renal impairment.
  • Contraindications for tocolysis, such as intrauterine demise, intrauterine infection, fetal distress, placental separation, or severe pre-eclampsia.
  • Cervical dilatation \> 5 cm.
  • Cervical length \> 30 mm by trans-vaginal ultrasound.
  • Cervical cerclage.

Key Trial Info

Start Date :

April 10 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2026

Estimated Enrollment :

264 Patients enrolled

Trial Details

Trial ID

NCT05345132

Start Date

April 10 2022

End Date

February 1 2026

Last Update

December 8 2023

Active Locations (1)

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Assiut University

Asyut, Egypt, 71111