Magnesium Sulphate in Premature Rupture of Membranes

Assiut University

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Premature Rupture of Membrane

Treatments

Drug: Magnesium sulfate

Study type

Observational

Funder types

Other

Identifiers

NCT05134688

Magnesium sulphate in PPROM

Details and patient eligibility

About

To assess the outcome of using magnesium sulphate on fetus and women with preterm premature rupture of membranes

Full 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

Enrollment

124 estimated patients

Sex

Female

Volunteers

Accepts 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