Dystocia Clinical Trial
Official title:
The Management of Spontaneous Labour in Primigravida (SLiP): Labor Scale Versus WHO Partograph
This study aims to compare the novel labour scale with the traditional WHO partograph in the management of spontaneous labour in primigravida in terms of maternal and neonatal outcomes
After many centuries through which vaginal delivery (VD) had been the only safe route of
birth, Cesarean section (CS) emerged as an alternative in emergency situations. CS has
gradually become an appealing option for both the mother and the obstetrician and its
indications increase while CS was proving safety; the rate of CS in U.S.A increased by about
50% within 10 years around the beginning of the current century. However, the increasing
prevalence of CS raises questions about the impact of this trend on maternal morbidity,
mortality as well as its economic burden. Accordingly, recent guidelines have been directed
to revise practice-base CS indications to only situations when CS is truly beneficial to the
mother and/or the fetus.
Of these indications, the most reported one was labour dystocia. The WHO partograph is a
famous chart that is commonly used to observe uncomplicated labour and is almost an
objective approach to guide interference. Unfortunately, the rule of the partograph in
reducing the incidence of CS is questionable. Furthermore, the design of the partograph is
not exactly perfect to present the process of labour. For these reasons, the labour scale
was designed as a novel follow-up chart during labour. The chart considered more objective
and timed management of labour with more flexible range of time based on recent evidence. A
previous pilot study on 77 women suggested that the labour scale may be a good alternative
to the current partograph. This study is the first randomized trial the compares the 2
charts as regards the rate of CS, maternal and neonatal health outcomes and both patient and
obstetrician satisfaction.
In this clinical trial, the investigators aim to compare the labour scale to the traditional
WHO partograph in terms of incidence of labor dystocia and CS as well as maternal and
neonatal outcomes
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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