ASTOS1: Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: A Nifedipine + Magnesium sulfate |
Drug: Nifedipine 20 Mg
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.
Drug: Magnesium sulfate
Women will also receive MgSo4 as 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.
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| Active Comparator: B Magnesium Sulfate |
Drug: Magnesium sulfate
Women will also receive MgSo4 as 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.
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Outcome Measures
Primary Outcome Measures
- 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
- Perinatal mortality [From starting treatment until 1 month of delivery]
Death of the offspring during treatment, labor or neonatal period
- A composite of adverse neonatal outcomes [within 1 month of delivery]
convulsions, apnoea, asphyxia, proven meningitis, pneumothorax or sepsis
- 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
- 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
- Delivery after 37 weeks of gestation. [after 37th week of delivery]
number of women delivered after 37 weeks of gestation
- Number of days till delivery [from starting the intervention until delivery]
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pregnant women with threatened preterm labor defined as 3 or more uterine contractions in 30 minutes confirmed by cardiotocography.
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Gestational age from 28 week + 0 days to (inclusive) 31 weeks + 6 days.
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Women with singleton or multiple pregnancy.
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Women with preterm prelabor rupture of membranes (PROM) will be included if they have uterine contractions.
Exclusion Criteria:
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Contraindications for the use of either drugs, such as cardiac disease, hypotension, myasthenia gravis, or renal impairment.
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Contraindications for tocolysis, such as intrauterine demise, intrauterine infection, fetal distress, placental separation, or severe pre-eclampsia.
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Cervical dilatation > 5 cm.
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Cervical length > 30 mm by trans-vaginal ultrasound.
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Cervical cerclage.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ASsiut TOcolytic Study 1