Comparing nifedipine and magnesium sulfate for preventing preterm labor

Nifedipine Versus Magnesium Sulfate for Tocolysis in Pregnant Women at 32 - 36 Weeks Gestation With Threatened Preterm Labor

This study is testing whether nifedipine or magnesium sulfate is better at stopping preterm labor in pregnant women between 32 and 36 weeks along.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Assiut University (other)
• Locations: 1 site (Assiut)
• Trial ID: NCT05343806 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of nifedipine compared to magnesium sulfate for tocolysis in pregnant women experiencing threatened preterm labor. The study will enroll 264 women between 32 and 36 weeks of gestation who show signs of preterm labor, and they will be randomly assigned to receive either nifedipine or magnesium sulfate. The primary outcome will be the number of women who do not deliver within 48 hours of treatment. All participants will also receive corticosteroids to promote fetal lung maturity as per local protocols.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women aged 18 and older, between 32 and 36 weeks of gestation, experiencing signs of threatened preterm labor.

Not a fit: Patients with contraindications for either nifedipine or magnesium sulfate, or those with severe complications such as intrauterine infection or significant cervical dilation, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for managing threatened preterm labor, potentially improving outcomes for both mothers and infants.

How similar studies have performed: Other studies have explored tocolytic treatments, but this specific comparison of nifedipine and magnesium sulfate is relatively novel.

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.

Where this trial is running

Assiut

• Faculty of Medicine, Assiut University — Assiut, Egypt (RECRUITING)

Study contacts

• Study coordinator: Karim Abdallah, MD

Conditions: Threatened Preterm Labor