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

Launched by ASSIUT UNIVERSITY · Apr 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two different treatments for women who are experiencing threatened preterm labor, which means they are having contractions and may give birth before 37 weeks of pregnancy. The trial is comparing the combination of nifedipine (a medication that helps relax the uterus) and magnesium sulfate (a common treatment to delay labor) against magnesium sulfate alone. The goal is to see which treatment helps prevent delivery within 48 hours of starting the medication.

To participate in this study, women must be between 28 and 31 weeks pregnant and at least 18 years old, showing signs of threatened preterm labor, such as having three or more contractions in 30 minutes. Women with certain medical conditions or complications may not be eligible. If a woman joins the trial, she will be randomly assigned to receive one of the treatments. All participants will also receive medication to help the baby’s lungs develop. The researchers will monitor various outcomes, such as how long the pregnancy can be prolonged and any health impacts on the mother or baby. This trial is currently recruiting participants.

Gender

FEMALE

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 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 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.