Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38

Induction of Labor Clinical Trial

Official title:

Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916291
• Other study ID #: Propess in PROM or GA<38
• Status: Completed
• Phase: Phase 2
• Start date: August 25, 2013
• Est. completion date: April 4, 2019

Study information

• Verified date: September 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has intact membrane after 38weeks of gestational age. The investigators study safety and efficacy of dinoprostone in the pregnant women with premature rupture of membrane or GA<38weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: April 4, 2019
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnant women who admitted for induction of labor

• Bishop score <= 6

Exclusion Criteria:

• Contraindication to induction of labor

• Active labor

• Vaginal bleeding, unknown origin

• Hypersensitive to Prostaglandin E

• History of asthma, glaucoma

• Infection (birth canal)

• Placental abruption

• Multiparity(>5)

• Pelvic inflammatory disease

• Heart, lung, kidney disease

• Multiple pregnancy

• Major anomaly

• Fetal distress before induction of labor

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Induction of Labor
• Rupture

Intervention

Drug:
• Propess insertion group

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	Induction success rate after propess insertion		Day 1 after propess insertion
Secondary	Concentration of prostaglandinE		at delivery