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

NCT02538718 | Completed

• 1 other identifier: MgSO4 study
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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Ritodrine is the conventional and the only approved tocolytics in Korea(by KFDA), although it was withdrawn from the US market more than 10 years ago.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

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

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

  48 hours later

Study Arms (2)

YTP(ritodrine) arm

ACTIVE COMPARATOR

who randomly assigned to have Yutopar(ritodrine) as tocolytics

Drug: YTP(Ritodrine)

MgSO4 arm

EXPERIMENTAL

who were randomised to have MgSO4 as tocolytics

Drug: MgSO4

Interventions

MgSO4 DRUG

MgSO4 arm

YTP(Ritodrine) DRUG

YTP(ritodrine) arm

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (2)

Seoul National University Hospital

Seoul, 110744, South Korea

Location

Seoul Metropolitan Goverment Seoul National University Boramae Medical Center

Seoul, 156707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 35947046 DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Joong Shin Park, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 2, 2015
• Study Start: September 22, 2015
• Primary Completion: November 29, 2016
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

KR (2)