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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Threatened Preterm Labor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    April 8, 2022
    Last Updated
    April 19, 2022
    Sponsor
    Assiut University
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    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

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