NCT Number: NCT01916291
Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38
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
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Notify MeKey information
Conditions
Age range
20 year–50 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2
Primary location
Seoul Metropolitan Goverment Seoul National University Boramae Medical Center, Seoul, South Korea
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Induction success rate after propess insertion
Time frame: Day 1 after propess insertion
Secondary outcomes
-
Concentration of prostaglandinE
Time frame: at delivery
Sponsors and collaborators
Lead sponsor
Seoul National University Hospital
Other
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2018
- Study completion
- 2019
- First posted
- Aug 5, 2013
- Registry last updated
- Mar 24, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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