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

September 13, 2022 updated by: Doaa M. Mostafa, Assiut University

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

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Placenta previa is implantation of placenta on or near internal os .It is classified into major degree when lower edge of placenta lies within 2 cm from internal os , and minor degree if lower edge of placenta at lower uterine segment but more than 2 cm from internal os .

There are many risk factors for developing placenta previa including multi parity , multiple pregnancy , increased maternal age (>35y ) , previous uterine surgery , history of placenta previa (4-8%) .

A significant degree of uterine contractility has been observed with symptomatic placenta previa. It is directly associated with vaginal bleeding. However, a large percentage of women who have placenta previa associated with haemorrhage will experience subclinical uterine contractions before the onset of overt vaginal bleeding. Therefore, the use of tocolytic agents in management of placenta previa seems reasonable .

Magnesium sulfate alters calcium up take, binding and distribution in smooth muscles of the uterus, so reduces the frequency of cell depolarization and inhibits myometrial contraction .

In addition to its tocolytic action magnesium sulfate also provide neuroprotection to preterm infant . .

At women Health Hospital, Assiut University, Egypt our policy is using magnesium sulfate as first line for tocolysis for placenta previa patients with preterm uterine contractions. By giving a loading dose of 4 g on 150 ml saline intravenous infusion over 20 minutes, and a maintenance dose of 6g/6h on 500 ml saline slow intra venous infusion

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Asyūţ, Egypt, 71111
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 41 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Singleton pregnancy.
  2. Gestational age between 28 weeks to 37 weeks.
  3. Patients presented to the hospital with per vaginal bleeding and in whom a clinical diagnosis of placenta previa is confirmed by trans vaginal ultrasound.
  4. Placenta previa with preterm uterine contractions (< 3 contractions in 10 minutes)
  5. Ability to provide informed consent.

Exclusion Criteria:

  1. Placental abruption .
  2. Women with placenta previa and severe attack of bleeding need immediate termination
  3. Clinical criteria of intra uterine infection.
  4. intrauterine growth restriction .
  5. Fetal anomalies.
  6. Fetal distress.
  7. intrauterine fetal death.
  8. Preterm rupture of membrane
  9. High order multiple pregnancies.
  10. Treatment with any tocolytic agent before maternal transport.
  11. Inability or refusal to provide informed consent.
  12. Women with any contraindication for use of magnesium sulfate as patients with renal failure.
  13. Patients with bleeding disorder or on anticoagulant therapy .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low dose of magnesium sulfate group
patients will receive 4 g intravenous loading dose of magnesium sulfate on 150 ml saline over 20 minute period. Patients then will receive maintenance therapy with magnesium sulfate 1g / h
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.
Active Comparator: High dose of magnesium sulfate group
patients will receive 4 g intravenous loading dose of magnesium sulfate on 150 ml saline over 20 minute period. Patients then will receive maintenance therapy with magnesium sulfate 2g/h
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate efficacy (postponing delivery for 48h - till administration of dexamethasone ) of different regimens 0f MgSO4 in patients with pp in preterm . 2) Different regimens of MGSO4 and changes in cervical length
Time Frame: 48 hour
comparing efficacy of low vs high dose of MgSO4 to postpone preterm delivery in patients with symptomatic pp and subsequent changes in cervical length
48 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Gestational age at delivery
Time Frame: at time of delivery
at time of delivery
birth weight
Time Frame: at time of delivery
at time of delivery
number of full term babies
Time Frame: at time of delivery
at time of delivery
fetal and Neonatal death .
Time Frame: at time of delivery
at time of delivery
Apgar score at five minutes .
Time Frame: 5 minutes
5 minutes
Neonatal intensive care unit admission & duration of admission
Time Frame: at time of delivery
at time of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

August 20, 2022

Study Completion (Actual)

August 20, 2022

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 18, 2020

First Posted (Actual)

October 23, 2020

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mgso4 for PTL in pp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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