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NCT Number: NCT05134688

Magnesium Sulphate in Premature Rupture of Membranes

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulfate

Drug

Tocolytic to stop preterm labor

Primary outcomes

  1. Latency period after rupture of membranes

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Fathi

CONTACT

[email protected]

01002058742

Diaa eldeen Abdelaal

CONTACT

[email protected]

01005212137

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Magnesium Sulphate for Tocolysis in Preterm Prelabour Rupture of Membranes

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 26, 2021
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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