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

Preterm Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538718
• Other study ID #: MgSO4 study
• Status: Completed
• Phase: N/A
• Start date: September 22, 2015

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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Ritodrine is the conventional and the only approved tocolytics in Korea(by KFDA), although it was withdrawn from the US market more than 10 years ago.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. primary completion date: November 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Drug:
• MgSO4

• YTP(Ritodrine)

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Goverment Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of MgSO4 as tocolytics : increased interval of uterine contraction, decreased maternal painful sensation, stopping the cervical change		48 hours later