Nifedipine Versus Magnesium Sulfate for Late Early Preterm Tocolysifs (ASTOS2)
Threatened Preterm Labor
About this trial
This is an interventional treatment trial for Threatened Preterm Labor
Eligibility Criteria
Inclusion Criteria:
- Pregnant women with threatened preterm labor defined as 3 or more uterine contractions in 30 minutes confirmed by cardiotocography.
- Gestational age from 32 week + 0 days to (inclusive) 36 weeks + 0 days.
- Women with singleton or multiple pregnancy.
- Women with preterm prelabor rupture of membranes (PROM) will be included if they have uterine contractions.
Exclusion Criteria:
- 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.
Sites / Locations
- Faculty of Medicine, Assiut University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Nifedipine
Magnesium Sulfate
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.
Women will receive only MgSo4. 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.