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High Versus Low Dose of Magnesium Sulfate as Initial Tocolytic Agent for Preterm Labour in Symptomatic Placenta Previa.

NCT04599868 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2022-09-14

No results posted yet for this study

Summary

To assess the efficacy and safety of alternative magnesium sulfate regimens when used as single agent tocolytic therapy for prevention of preterm labour in patients with symptomatic placenta previa and subsequent changes in the cervical length .

Conditions

  • Placenta Previa Bleeding

Interventions

DRUG

Magnesium sulfate

Patients will be assessed hourly for pulse and blood pressure, contraction frequency, vaginal bleeding. With strict monitoring for symptoms of magnesium sulfate toxicity. All patients will receive dexamethasone to enhance fetal lung maturity. Rhesus factor status will be determined for all patients, . Hb level will be measured and anemic patients will receive correction by blood transfusion Cervical length will be measured after 24 h\& 48 h from administration of magnesium sulfate in both groups Maternal serum magnesium will be measured at admission and after 4 hours ,12 hours and 24 hours after administration of magnesium sulfate Patients of both groups will be assessed for their neonatal outcomes include deaths and gestational age at delivery, fetal birth weight. Apgar score at five minutes, neonatal intensive care unit admission and duration of admission and neonatal calcium level at time of delivery will be also assessed.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-08-20
Completion
2022-08-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04599868 on ClinicalTrials.gov