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

Primary Purpose

Preterm Labor

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MgSO4
YTP(Ritodrine)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Labor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital
  • Seoul Metropolitan Goverment Seoul National University Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

YTP(ritodrine) arm

MgSO4 arm

Arm Description

who randomly assigned to have Yutopar(ritodrine) as tocolytics

who were randomised to have MgSO4 as tocolytics

Outcomes

Primary Outcome Measures

Efficacy of MgSO4 as tocolytics : increased interval of uterine contraction, decreased maternal painful sensation, stopping the cervical change

Secondary Outcome Measures

Full Information

First Posted
August 28, 2015
Last Updated
April 23, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02538718
Brief Title
Efficacy and Safety of MgSO4 as Tocolytics Compared to Ritodrine in Preterm Labor
Official Title
Efficacy and Safety of MgSO4 as Tocolytics Compared to Ritodrine in Preterm Labor
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 22, 2015 (Actual)
Primary Completion Date
November 29, 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YTP(ritodrine) arm
Arm Type
Active Comparator
Arm Description
who randomly assigned to have Yutopar(ritodrine) as tocolytics
Arm Title
MgSO4 arm
Arm Type
Experimental
Arm Description
who were randomised to have MgSO4 as tocolytics
Intervention Type
Drug
Intervention Name(s)
MgSO4
Intervention Type
Drug
Intervention Name(s)
YTP(Ritodrine)
Primary Outcome Measure Information:
Title
Efficacy of MgSO4 as tocolytics : increased interval of uterine contraction, decreased maternal painful sensation, stopping the cervical change
Time Frame
48 hours later

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joong Shin Park, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
Facility Name
Seoul Metropolitan Goverment Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
156707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
35947046
Citation
Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
Results Reference
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Efficacy and Safety of MgSO4 as Tocolytics Compared to Ritodrine in Preterm Labor

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