Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs
- Conditions
- Threatened Preterm Labor
- Interventions
- Registration Number
- NCT05345132
- Lead Sponsor
- Assiut University
- 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 Population: The population will include pregnant women at gestational age between 28 and 31 weeks who are 18 years old or older and have signs of threatened preterm labor.
Study Design: This is a single-center, prospective, randomized controlled clinical trial. A total of 264 women pregnant between 28 and 31 weeks having threatened preterm labor will be enrolled and randomized into two parallel treatment arms. Patients in the group A will receive nifedipine plus MgSO4, while patients in group B will MgSO4 only.
Treatment: All patients will be randomized on the day of enrollment. Patients with threatened preterm labor will receive the respective tocolysis in each group. All patients will receive corticosteroids for lung maturity according to the local protocol.
Primary outcome: Number of women not delivered within 48 hours of starting tocolytic therapy.
Secondary outcomes: perinatal mortality, a composite of adverse neonatal outcomes, birth weight, days on ventilation support, length of admission in neonatal intensive care, prolongation of pregnancy more than 7 days, delivery after 37 weeks of gestation, number of days till delivery, maternal mortality, maternal infection, and harm to mother from intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 264
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Nifedipine 20 Mg Nifedipine + Magnesium sulfate B Magnesium sulfate Magnesium Sulfate A Magnesium sulfate Nifedipine + Magnesium sulfate
- Primary Outcome Measures
Name Time Method Number of women not delivered within 48 hours of starting tocolytic therapy. 48 hours postponing delivery for at least 48 hours to allow the time for corticosteroid administration for fatal lung maturity
- Secondary Outcome Measures
Name Time Method Perinatal mortality From starting treatment until 1 month of delivery Death of the offspring during treatment, labor or neonatal period
days on ventilation support within 1 month of delivery number of days on mechanical ventilation
length of admission in neonatal intensive care within 1 month of delivery Number of days in the NICU
Delivery after 37 weeks of gestation. after 37th week of delivery number of women delivered after 37 weeks of gestation
A composite of adverse neonatal outcomes within 1 month of delivery convulsions, apnoea, asphyxia, proven meningitis, pneumothorax or sepsis
Number of days till delivery from starting the intervention until delivery Harm to mother from interventions (side effects) from starting treatment until 1 month after delivery admission to intensive care, anaphylactic shock, dyspnoea, hypotension (leading to cardiotocography abnormalities), liver test abnormalities (elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT)), general side effects (nausea, vomiting, headache) and postpartum haemorrhage defined as \>500 mL blood loss
Prolongation of pregnancy more than 7 days 7 days after initiation of therapy Number of women not delivering after at least 7 days from starting the intervention
Maternal mortality rate from starting treatment until 1 month after delivery Number of maternal deaths during pregnancy, labor or puerperium
Maternal infection rate from starting treatment until 1 month after delivery Number of women having Chorioamnionitis, Puerperal sepsis, endometritis, or sepsis
Trial Locations
- Locations (1)
Assiut University
🇪🇬Assiut, Egypt