An interventional study of Nifedipine 20 Mg and Magnesium sulfate in Threatened Preterm Labor, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 264 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
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Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Nifedipine + Magnesium sulfate
Drug: Nifedipine 20 Mg · Drug: Magnesium sulfate
Magnesium Sulfate
Drug: Magnesium sulfate
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.
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.
Number of women not delivered within 48 hours of starting tocolytic therapy.
postponing delivery for at least 48 hours to allow the time for corticosteroid administration for fatal lung maturity
Time frame: 48 hours
Perinatal mortality
Death of the offspring during treatment, labor or neonatal period
Time frame: From starting treatment until 1 month of delivery
A composite of adverse neonatal outcomes
convulsions, apnoea, asphyxia, proven meningitis, pneumothorax or sepsis
Time frame: within 1 month of delivery
days on ventilation support
number of days on mechanical ventilation
Time frame: within 1 month of delivery
length of admission in neonatal intensive care
Number of days in the NICU
Time frame: within 1 month of delivery
Prolongation of pregnancy more than 7 days
Number of women not delivering after at least 7 days from starting the intervention
Time frame: 7 days after initiation of therapy
Delivery after 37 weeks of gestation.
number of women delivered after 37 weeks of gestation
Time frame: after 37th week of delivery
Number of days till delivery
Time frame: from starting the intervention until delivery
Maternal mortality rate
Number of maternal deaths during pregnancy, labor or puerperium
Time frame: from starting treatment until 1 month after delivery
Maternal infection rate
Number of women having Chorioamnionitis, Puerperal sepsis, endometritis, or sepsis
Time frame: from starting treatment until 1 month after delivery
Harm to mother from interventions (side effects)
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
Time frame: from starting treatment until 1 month after delivery
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr
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Assiut University