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Magnesium Sulphate in Premature Rupture of Membranes

Magnesium Sulphate for Tocolysis in Preterm Prelabour Rupture of Membranes

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05134688
Enrollment
124
Registered
2021-11-26
Start date
2024-07-30
Completion date
2024-12-01
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Rupture of Membrane

Keywords

Magnesium sulphate

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

Interventions

DRUGMagnesium sulfate

Tocolytic to stop preterm labor

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Contacts

Primary ContactAhmed Fathi
Ahmedalfathi94@gmail.com01002058742
Backup ContactDiaa eldeen Abdelaal
Abdelaald@yahoo.com01005212137

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026