Labor Scale Versus WHO Partograph in the Management of Labor (SLiP)

Assiut University

Status: Unknown

Conditions: Dystocia

Treatments: Procedure: Amniotomy; Procedure: Cesarean Section; Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT02486822

IRB00008718 - SLiP

Details and patient eligibility

About

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

Full 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

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primigravida
• 38 - 42 weeks of gestation
• Singleton pregnancy
• Vertex presentation
• Spontaneous labour
• Average estimated fetal weight (2500 - 3800 gram)

Exclusion criteria

• Maternal medical or surgical major co-morbidity
• Previous uterine scar
• Induction of labor
• Premature rupture of membranes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Labor scale

Experimental group

Description:

Observation Amniotomy Oxytocin Cesarean Section (CS)

Treatment:

Procedure: Cesarean Section

Drug: Oxytocin

Procedure: Amniotomy

WHO partograph

Active Comparator group

Description:

Observation Amniotomy Oxytocin Cesarean Section (CS)

Treatment:

Procedure: Cesarean Section

Drug: Oxytocin

Procedure: Amniotomy