Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs (ASTOS1)
Primary Purpose
Threatened Preterm Labor
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nifedipine 20 Mg
Magnesium sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Threatened Preterm Labor
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
Nifedipine + Magnesium sulfate
Magnesium Sulfate
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Perinatal mortality
Death of the offspring during treatment, labor or neonatal period
A composite of adverse neonatal outcomes
convulsions, apnoea, asphyxia, proven meningitis, pneumothorax or sepsis
days on ventilation support
number of days on mechanical ventilation
length of admission in neonatal intensive care
Number of days in the NICU
Prolongation of pregnancy more than 7 days
Number of women not delivering after at least 7 days from starting the intervention
Delivery after 37 weeks of gestation.
number of women delivered after 37 weeks of gestation
Number of days till delivery
Maternal mortality rate
Number of maternal deaths during pregnancy, labor or puerperium
Maternal infection rate
Number of women having Chorioamnionitis, Puerperal sepsis, endometritis, or sepsis
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05345132
Brief Title
Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs
Acronym
ASTOS1
Official Title
Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate Alone for Tocolysis in Pregnant Women at 28 - 31 Weeks Gestation With Threatened Preterm Labor
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Threatened Preterm Labor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Nifedipine + Magnesium sulfate
Arm Title
B
Arm Type
Active Comparator
Arm Description
Magnesium Sulfate
Intervention Type
Drug
Intervention Name(s)
Nifedipine 20 Mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of women not delivered within 48 hours of starting tocolytic therapy.
Description
postponing delivery for at least 48 hours to allow the time for corticosteroid administration for fatal lung maturity
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Perinatal mortality
Description
Death of the offspring during treatment, labor or neonatal period
Time Frame
From starting treatment until 1 month of delivery
Title
A composite of adverse neonatal outcomes
Description
convulsions, apnoea, asphyxia, proven meningitis, pneumothorax or sepsis
Time Frame
within 1 month of delivery
Title
days on ventilation support
Description
number of days on mechanical ventilation
Time Frame
within 1 month of delivery
Title
length of admission in neonatal intensive care
Description
Number of days in the NICU
Time Frame
within 1 month of delivery
Title
Prolongation of pregnancy more than 7 days
Description
Number of women not delivering after at least 7 days from starting the intervention
Time Frame
7 days after initiation of therapy
Title
Delivery after 37 weeks of gestation.
Description
number of women delivered after 37 weeks of gestation
Time Frame
after 37th week of delivery
Title
Number of days till delivery
Time Frame
from starting the intervention until delivery
Title
Maternal mortality rate
Description
Number of maternal deaths during pregnancy, labor or puerperium
Time Frame
from starting treatment until 1 month after delivery
Title
Maternal infection rate
Description
Number of women having Chorioamnionitis, Puerperal sepsis, endometritis, or sepsis
Time Frame
from starting treatment until 1 month after delivery
Title
Harm to mother from interventions (side effects)
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karim S Abdallah, MD
Phone
+201270595485
Email
karimsayed88@aun.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Nifedipine Plus Magnesium Sulfate Versus Magnesium Sulfate for Very Early Preterm Tocolysifs
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