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Not Yet RecruitingNCT05134688

Magnesium Sulphate in Premature Rupture of Membranes

Magnesium Sulphate for Tocolysis in Preterm Prelabour Rupture of Membranes

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
124 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
Female
Age
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
DRUGMagnesium sulfateTocolytic to stop preterm labor

Timeline

Start date
2024-07-30
Primary completion
2024-09-01
Completion
2024-12-01
First posted
2021-11-26
Last updated
2024-07-22

Source: ClinicalTrials.gov record NCT05134688. Inclusion in this directory is not an endorsement.