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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01916291

Enrollment

189

Registered

2013-08-05

Start date

2013-08-25

Completion date

2019-04-04

Last updated

2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor

Brief 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

Interventions

DRUGPropess insertion group

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Induction success rate after propess insertion	Day 1 after propess insertion

Secondary

Measure	Time frame
Concentration of prostaglandinE	at delivery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026