Comparing nifedipine plus magnesium sulfate to magnesium sulfate alone for threatened preterm labor
Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate Alone for Tocolysis in Pregnant Women at 28 - 31 Weeks Gestation With Threatened Preterm Labor
This study is testing if adding nifedipine to magnesium sulfate can help pregnant women in preterm labor more than just using magnesium sulfate alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Assiut) |
| Trial ID | NCT05345132 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of nifedipine combined with magnesium sulfate versus magnesium sulfate alone in treating women experiencing threatened preterm labor. The study will enroll 264 pregnant women between 28 and 31 weeks of gestation who show signs of preterm labor. Participants will be randomly assigned to receive either the combination treatment or magnesium sulfate alone, with all patients also receiving corticosteroids for fetal lung maturity. The primary outcome will focus on the number of women successfully managed with the respective treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older, between 28 and 31 weeks of gestation, experiencing signs of threatened preterm labor.
Not a fit: Patients with contraindications to the medications used or those with severe complications of pregnancy 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: While this approach is being tested in this specific context, similar studies have shown promise in using combination therapies for tocolysis.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Assiut
- Assiut University — Assiut, Egypt (Recruiting)
Study contacts
- Study coordinator: Karim S Abdallah, MD
- Email: karimsayed88@aun.edu.eg
- Phone: +201270595485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.