Efficacy and Safety of MgSO4 as Tocolytics Compared to Ritodrine in Preterm Labor

April 23, 2019 updated by: Seoul National University Hospital
Ritodrine is the conventional and the only approved tocolytics in Korea(by KFDA), although it was withdrawn from the US market more than 10 years ago. As already known well, ritodrine has many side effects such as tachycardia, hyperglycemia, pulmonary edema and so on. When such complications of ritodrine appears, clinicians consider of using MgSO4 as substitute, but its use is off-the-label yet in Korea. Facing this discrepancy, the investigators want to compare the efficacy and safety of MgSO4 with ritodrine and prove that MgSO4 is not inferior to ritodrine as tocolytics. For the singleton and twin pregnancies between 24+0weeks and 34 completed weeks whose uterine contraction is more than 4 during 20 minutes period with their cervical ripening is more than 25%, the investigators randomise them in Ritodrine group or MgSO4 group. Then, the investigators will check the change of their interval of uterine contraction, degree of pain and the appearance of any side effects or treatment failure sign.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 156707
        • Seoul Metropolitan Goverment Seoul National University Boramae Medical Center

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestational age of 24+0 to 34+6weeks
  • singleton and twin pregnancies
  • preterm labor with more than 4 times of uterine contraction for 20 minutes or more than 8 times for 1 hour on external tocography
  • cervical dilatation of 0 to 3cm and cervical ripening more than 25%, or cervical length in sonography below 2cm

Exclusion Criteria:

  • triplet etc
  • preterm premature rupture of membrane
  • cervical dilatation more than 3cm
  • history of cerclage operation during this pregnancy
  • placenta previa
  • severe hypertensive diseases in pregnancy
  • history of administration of any tocolytics 12 hours before enrollment
  • fever more than 38.0'c

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: YTP(ritodrine) arm
who randomly assigned to have Yutopar(ritodrine) as tocolytics
Drug: YTP(Ritodrine)
Experimental: MgSO4 arm
who were randomised to have MgSO4 as tocolytics
Drug: MgSO4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of MgSO4 as tocolytics : increased interval of uterine contraction, decreased maternal painful sensation, stopping the cervical change
Time Frame: 48 hours later
48 hours later

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Joong Shin Park, M.D., Ph.D., Seoul National University Hospital

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)

September 22, 2015

Primary Completion (Actual)

November 29, 2016

Study Registration Dates

First Submitted

August 28, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MgSO4 study

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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