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

Plain Language Summary

Simplified for easier understanding

This study compares two methods of inducing labour in women at term (37 weeks or more) whose waters have broken but labour has not started on its own (called prelabour rupture of membranes, or PROM). The two methods are: an oxytocin drip (the current standard approach, given through an IV) or prostaglandin gel (inserted vaginally). Prostaglandin gel may allow more freedom of movement and is less invasive. The study measures safety, effectiveness, and how satisfied women are with each method. You may be eligible if: - You are 16 years or older - You are at least 37 weeks pregnant (term) with your waters broken - You are carrying a single baby in a head-down position - The baby is alive and doing well You may NOT be eligible if: - You have a serious medical problem - There are signs the baby is in distress requiring immediate delivery - There are signs of infection (sepsis) - You have had a previous caesarean section - You have a confirmed Group B Streptococcus (GBS) infection Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12612000093886