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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000093886

Acronym

PO PROM

Enrollment

184

Registered

2012-01-18

Start date

2009-02-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

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 gel will be inserted vaginally

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results