RecruitingPhase 3ACTRN12612000093886

Prostaglandin gel versus oxytocin for induction of labour in term prelabour rupture of membranes

For women with term prelabour rupture of membranes who wish active management does use of PG gel result in better satisfaction and less need for oxytocin without increasing risk of neonatal sepsis.


Sponsor

ipswich Hospital

Enrollment

280 participants

Start Date

Feb 1, 2009

Study Type

Interventional

Conditions

Summary

Term PROM is a common problem. Women have traditionally been offered oxytocin infusion. This requires intravenous fluids, continuous FHR monitoring and the woman is restricted to bed. PG gel has been shown in a large RCT to be safe and effective but has not become widely used in the public sector. This study will address safety and efficacy as well as womens satisfaction of the two methods of induction.


Eligibility

Sex: FemalesMin Age: 16 Yearss

Inclusion Criteria6

  • gestational age >36 weeks and 6 days
  • Confirmed SROM
  • Singleton pregnancy
  • live fetus
  • cephalic presentation
  • informed consent

Exclusion Criteria6

  • severe medical problem
  • compromised fetus
  • indication for immediate delivery
  • suspected sepsis
  • previous c/section
  • known gbs infection

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Interventions

Three doses of Prostaglandin F2 alpha gel 6 hours apart = first dose after obtaining consent doses are 2mg each time for nulliparous women and 1mg initially and then 2 mg for multiparous women g

Three doses of Prostaglandin F2 alpha gel 6 hours apart = first dose after obtaining consent doses are 2mg each time for nulliparous women and 1mg initially and then 2 mg for multiparous women gel will be inserted vaginally


Locations(1)

QLD, Australia

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ACTRN12612000093886