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Magnesium Sulphate in Premature Rupture of Membranes

Primary Purpose

Premature Rupture of Membrane

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Magnesium sulfate
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Premature Rupture of Membrane focused on measuring Magnesium sulphate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • pregnant women with gastational age between 28 weeks and 36 weeks and 6 days who are diagnosed with preterm prelabour rupture of membranes

Exclusion Criteria:

  • clinical suspicion of chorioamnionitis
  • Patients refusal to participate in clinical research.
  • significant vaginal bleeding
  • previous tocolysis use after rupture of membranes
  • nonreassuring fetal heart tracing
  • fetal anomalies
  • significant maternal medical complications, and maternal or fetal indication for delivery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Grup 1

    Group 2

    Arm Description

    Group receive magnesium sulphate IV(4gm loading dose over 20 minutes followed by 1gm /hour for 6 hours

    Receive no further treatment than conservative mangement( antibiotics and steroids)

    Outcomes

    Primary Outcome Measures

    Latency period after rupture of membranes
    Measure letancy period between prelabour rupture of membranes and delivery during using magnesium sulphate as a tocolytic and without using magnesium sulphate

    Secondary Outcome Measures

    Full Information

    First Posted
    November 15, 2021
    Last Updated
    May 8, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05134688
    Brief Title
    Magnesium Sulphate in Premature Rupture of Membranes
    Official Title
    Magnesium Sulphate for Tocolysis in Preterm Prelabour Rupture of Membranes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 30, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (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

    5. Study Description

    Brief Summary
    To assess the outcome of using magnesium sulphate on fetus and women with preterm premature rupture of membranes
    Detailed Description
    Preterm premature rupture of membranes (PPROM) is defined as rupture of the chorioamniotic membranes before the onset of labor prior to 37 weeks of gestation. Approximately 1% to 5% of pregnancies are complicated by PPROM . PPROM contributes to perinatal morbidity and mortality, secondary to premature birth, and maternal morbidity. Overall, PPROM accounts for about one-third of all preterm births . In order to reduce the effects of prematurity, early PPROM (24 to 33 weeks) is best served with conservative management in the absence of labor, infection, or fetal distress . The conservative management of PPROM consists of the use of antibiotic treatment and antenatal steroid to enhance fetal lung maturity . With or without the presence of labor, it is unclear whether tocolysis of women with PPROM would be efficacious in reducing the consequences of prematurity .The use of tocolytics in women with PPROM is still controversial. Many physicians use tocolytic therapy as a prophylactic measure and others initiate tocolysis only with the onset of contractions. There is also a variety of options for tocolysis: betamimetics, calcium channel blockers, cyclo-oxygenase (COX) inhibitors, oxytocin receptor antagonists and magnesium sulphate . As betamimetis is not available and isn't used in our country and magnesium sulphate is available magnesium sulphate is used widly. The loading dose of magnesium sulphate is IV 4 gm over 20 minutes followed by 1gm/hour for 6 hours The potential benefit from increased latency due to tocolysis must be weighed against the potential harm in increased maternal and perinatal infection, the latter of which can possibly lead to long-term sequelae for the child, including cerebral palsy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Rupture of Membrane
    Keywords
    Magnesium sulphate

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    260 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Grup 1
    Arm Type
    Active Comparator
    Arm Description
    Group receive magnesium sulphate IV(4gm loading dose over 20 minutes followed by 1gm /hour for 6 hours
    Arm Title
    Group 2
    Arm Type
    No Intervention
    Arm Description
    Receive no further treatment than conservative mangement( antibiotics and steroids)
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium sulfate
    Intervention Description
    Tocolytic to stop preterm labor
    Primary Outcome Measure Information:
    Title
    Latency period after rupture of membranes
    Description
    Measure letancy period between prelabour rupture of membranes and delivery during using magnesium sulphate as a tocolytic and without using magnesium sulphate
    Time Frame
    Baseline

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: pregnant women with gastational age between 28 weeks and 36 weeks and 6 days who are diagnosed with preterm prelabour rupture of membranes Exclusion Criteria: clinical suspicion of chorioamnionitis Patients refusal to participate in clinical research. significant vaginal bleeding previous tocolysis use after rupture of membranes nonreassuring fetal heart tracing fetal anomalies significant maternal medical complications, and maternal or fetal indication for delivery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Fathi
    Phone
    01002058742
    Email
    Ahmedalfathi94@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Diaa eldeen Abdelaal
    Phone
    01005212137
    Email
    Abdelaald@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9486996
    Citation
    Parry S, Strauss JF 3rd. Premature rupture of the fetal membranes. N Engl J Med. 1998 Mar 5;338(10):663-70. doi: 10.1056/NEJM199803053381006. No abstract available.
    Results Reference
    background
    PubMed Identifier
    6988128
    Citation
    Kaltreider DF, Kohl S. Epidemiology of preterm delivery. Clin Obstet Gynecol. 1980 Mar;23(1):17-31. doi: 10.1097/00003081-198003000-00005.
    Results Reference
    background
    PubMed Identifier
    17400872
    Citation
    ACOG Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 80: premature rupture of membranes. Clinical management guidelines for obstetrician-gynecologists. Obstet Gynecol. 2007 Apr;109(4):1007-19. doi: 10.1097/01.AOG.0000263888.69178.1f.
    Results Reference
    background
    PubMed Identifier
    17636741
    Citation
    Crowther CA, Harding JE. Repeat doses of prenatal corticosteroids for women at risk of preterm birth for preventing neonatal respiratory disease. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003935. doi: 10.1002/14651858.CD003935.pub2.
    Results Reference
    background
    PubMed Identifier
    26662716
    Citation
    McNamara HC, Crowther CA, Brown J. Different treatment regimens of magnesium sulphate for tocolysis in women in preterm labour. Cochrane Database Syst Rev. 2015 Dec 14;2015(12):CD011200. doi: 10.1002/14651858.CD011200.pub2.
    Results Reference
    background
    PubMed Identifier
    20664400
    Citation
    Shatrov JG, Birch SCM, Lam LT, Quinlivan JA, McIntyre S, Mendz GL. Chorioamnionitis and cerebral palsy: a meta-analysis. Obstet Gynecol. 2010 Aug;116(2 Pt 1):387-392. doi: 10.1097/AOG.0b013e3181e90046.
    Results Reference
    background
    PubMed Identifier
    3134815
    Citation
    Weiner CP, Renk K, Klugman M. The therapeutic efficacy and cost-effectiveness of aggressive tocolysis for premature labor associated with premature rupture of the membranes. Am J Obstet Gynecol. 1988 Jul;159(1):216-22. doi: 10.1016/0002-9378(88)90524-8. Erratum In: Am J Obstet Gynecol 1991 Sep;165(3):785.
    Results Reference
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    Magnesium Sulphate in Premature Rupture of Membranes

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