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

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Seoul National University

Status and phase

Completed
Phase 2

Conditions

Induction of Labor

Treatments

Drug: Propess insertion group

Study type

Interventional

Funder types

Other

Identifiers

NCT01916291
Propess in PROM or GA<38

Details and patient eligibility

About

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

Enrollment

189 patients

Sex

Female

Ages

20 to 50 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

189 participants in 1 patient group

Propess insertion
Experimental group
Treatment:
Drug: Propess insertion group

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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