Term PreLabour Rupture of Membranes ( TermPROM )

1. Term PreLabour Rupture of Membranes (TermPROM) Max Brinsmead PhD FRANZCOG July 2011

2. Resources • NICE Guidelines “Intrapartum Care” September 2007 • RANZCOG Statement July 2010 • Cochrane Database “Planned early birth versus expectant management for prelabour rupture of membranes at term” January 2006

3. Definition, Incidence & Natural History • Rupture of membranes after 37 completed weeks of gestation and before the onset of labour • Occurs in 8% of pregnancies • In the absence of any intervention... • 70% of patients will labour within 24 hours • 85% will labour within 48 hours • 95% will labour within 96 hours

4. TermPROM –The Dilemma • Historically a risk of ascending infection and chorioamnionitis • So induction of labour by Syntocinon infusion became the management of choice • But some ended in failed induction, especially in nullipara with an unripe cervix • So two questions arose: • Is it safe to wait for spontaneous ripening? • Or can vaginal Prostaglandins be used? • These questions answered by the TermPROM trial

5. The TermPROM Study • A multicentre RCT of 5041 women with TermPROM randomly assigned to: • Immediate oxytocin infusion • Immediate vaginal prostaglandin E2 gel • Observation for up to 4 days • Primary outcome was the rate of neonatal infection • Secondary outcomes included measures of maternal infection, Caesarean section and satisfaction with care • Subgroup analysis compared care in hospital with at home and those with Gp B Streptococcus colonization

6. TermPROM Study Results

7. TermPROM Study Results • More women satisfied with active management • Higher rates of infection with vaginal prostaglandins but it did not reach statistical significance. • In pooled results with other studies this does reach statistical significance • A trend towards higher risk of infection with home vs hospital care (RR for nullips requiring antibiotics 1.52 CI 1.04 – 2.24) • An association with Gp B Strep colonization and infection • Early oxytocin infusion is the most cost effective management

8. TermPROM Study Outcome • Different outcomes for different stakeholders • Some saw it as a vindication for conservative management because the primary outcomes were not statistically different in the 3 main study groups • Others saw it as the opportunity to use Prostaglandins • Certainly it introduced an element of informed patient CHOICE • Most saw the trial as vindication for the long-established plan of management i.e. • Wait up to 24 hours to see if labour begins • Commence Syntocinon at a time that is convenient to all

9. Cochrane Review • 12 trials of 6814 women in 12 studies found that active vs expectant management resulted in... • No significant difference in the rate of Caesarean birth (RR=0.94, CI 0.82 -1.08) • Reduced risk of clinical chorioamnionitis (RR=0.74, CI 0.56 -0.97) • Reduced risk of endometritis (RR=0.30, CI 0.12-0.74) • No significant difference in the risk of neonatal infection (RR=0.83, CI 0.61-0.12) but... • Fewer infants requiring intensive/special care (RR=0.72. CI 0.57-0.92)

10. NICE Guidelines

11. RANZCOG Guidelines • Much more interventionist/proactive • Conservative management is only sanctioned for: • Those with a stable cephalic presentation • GBS negative • No digital VE or cervical suture • No signs of chorioamnionitis • Commitment to 4th hourly monitoring for signs of infection in hospital • A very low threshold for antibiotic use (18 hours) • Vaginal prostaglandins are better avoided

12. Some Practical Points • The diagnosis is best made by history, speculum examination and, for a few patients: • Observation over time • Tests for AF e.g. pH strips/sticks or Amnisure (expensive) • There is no role for ultrasound • If, at the end of the day, you can’t decide if the forewaters are ruptured they probably haven’t • Digital examination is to be avoided if you plan to offer a conservative approach • Always check during Syntocinon infusion to confirm ruptured forewaters

13. Detection of Chorioamnionitis • Requires a high index of suspicion and concern about... • Any low grade fever • Fetal (or maternal) tachycardia • Discolouration of the liquor • Uterine tenderness • Decreased fetal movements • Be aware that studies suggest that labour in the presence of chorioamnionitis can be DYSFUNCTIONAL • And with reduced sensitivity to Syntocinon

14. In Conclusion • Management of TermPROM depends on the context within which you are working • When there is poor maternal and fetal monitoring and high risk of chorioamnionitis then active management (early induction of labour) is appropriate • With informed patient consent ... • And on a background of very low tolerance for any delay in response to induction of labour... • Conservative management , particularly for a nulliparous with an unfavourable cervix , is attractive • Oral Misoprotol is a very good alternative

15. Any Questions or Comments? For copies of this Powerpoint go to www.brinsmead.net.au and follow the links to “Students”