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