Prelabour Rupture of Membranes at Term Clinical Trial
Official title:
"Active vs Expectant Management and Routine vs Only-when-necessary Vaginal Examinations During Labour for Prelabour Rupture of Membranes at Term, a Pilot RCT Study"
This is a pilot study that will eventually result in a main randomised controlled trial that
will look at what management is associated with a higher rate of normal birth and a lower
rate of chorioamnionitis (maternal infection) when women break their waters but labour does
not start. Spontaneous rupture of the membranes (when the waters break) at term (37-42 weeks
gestation) is a physiological event that happens during labour. However, according to Gunn
et al. (1970) in 8-10 % of the cases the membranes rupture before labour starts. The time
between the rupture and the onset of labour is called latent phase and time wise is
variable.
Studies have showed no statistically significant differences in terms of neonatal infection
or chorioamnionitis when the investigators induce labour with prostaglandins compared to
when labour starts spontaneously (Hannah et al 1996). Seaward et al. (1997) noted a number
of confounding factors that might relate to the incidence of chorioamnionitis (maternal
infection), the strongest predictor was having more than 8 vaginal examinations since the
rupture of membranes and before delivery which was a stronger predictor than the duration of
the latent phase. It is thought that by reducing the number of internal examinations,
chorioamnionitis may be reduced, and hence neonatal infection may also be reduced. The main
RCT will compare clinical outcomes and maternal satisfaction when women consent to be
randomized to four groups: (1) Active management and routine internal examinations during
labour, (2) Active management and reduced internal examinations, (3) Expectant management
and routine internal examinations, (4) Expectant management and reduced internal
examinations.
This application seeks ethics approval for the pilot phase to ensure that a definitive study
can be undertaken appropriately. It is important to test that all the components work well
individually and as a whole, to estimate sample size and ultimately to test the integrity of
the research protocol before embarking on the main trial.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment