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UnknownNCT02486822

Labor Scale Versus WHO Partograph in the Management of Labor

The Management of Spontaneous Labour in Primigravida (SLiP): Labor Scale Versus WHO Partograph

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
Female
Age
18 Years – 35 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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

Conditions

Interventions

TypeNameDescription
PROCEDUREAmniotomyAmniotomy, artificial rupture of membranes, is done with initial delay of labor (in partograph: extension beyond alert line, in labor scale: when progress reaches the membrane line)
DRUGOxytocinOxytocin augmentation: given with further delay of labour (according to the point of intervention of the partograph or the scale)
PROCEDURECesarean SectionCesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)

Timeline

Start date
2015-07-01
Primary completion
2016-06-01
Completion
2016-06-01
First posted
2015-07-01
Last updated
2016-05-11

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT02486822. Inclusion in this directory is not an endorsement.