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

Not Applicable

Completed

• Conditions: Preterm Labor
• Interventions: Drug: YTP(Ritodrine); Drug: MgSO4

• Registration Number: NCT02538718
• Lead Sponsor: Seoul National University Hospital

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Ritodrine is the conventional and the only approved tocolytics in Korea(by KFDA), although it was withdrawn from the US market more than 10 years ago.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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-02
• Study Start: 2015-09-22
• Primary Completion: 2016-11-29
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
YTP(ritodrine) arm	YTP(Ritodrine)	who randomly assigned to have Yutopar(ritodrine) as tocolytics
MgSO4 arm	MgSO4	who were randomised to have MgSO4 as tocolytics

Primary Outcome Measures

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

Trial Locations

Locations (2)

Seoul Metropolitan Goverment Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of