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

May 9, 2016 updated by: Sherif Abdelkarim Mohammed Shazly, Assiut University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut Faculty of Medicine - Women Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Labor scale
Observation Amniotomy Oxytocin Cesarean Section (CS)
Procedure: Cesarean Section
Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)
Other Names:
  • CS
Procedure: Amniotomy
Amniotomy, 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)
Other Names:
  • Artificial rupture of membranes
Drug: Oxytocin
Oxytocin augmentation: given with further delay of labour (according to the point of intervention of the partograph or the scale)
Other Names:
  • augmentation of labor
Active Comparator: WHO partograph
Observation Amniotomy Oxytocin Cesarean Section (CS)
Procedure: Cesarean Section
Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)
Other Names:
  • CS
Procedure: Amniotomy
Amniotomy, 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)
Other Names:
  • Artificial rupture of membranes
Drug: Oxytocin
Oxytocin augmentation: given with further delay of labour (according to the point of intervention of the partograph or the scale)
Other Names:
  • augmentation of labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported)
Time Frame: Time of labor (maximum 24 hours)
The proportion who delivered vaginal versus those indicated for Cesarean Section for labor dystocia
Time of labor (maximum 24 hours)

Secondary Outcome Measures

Outcome Measure
Time Frame
Intrapartum maternal distress (assessed by clinical signs of maternal distress and dehydration)
Time Frame: Time of labor (maximum 24 hours)
Time of labor (maximum 24 hours)
Intrapartum maternal birth injuries (assessed clinically at the time of labor, the extent and type of repair and subsequent complications will be reported)
Time Frame: Time of labour and hospital stay (expected average 72 hours)
Time of labour and hospital stay (expected average 72 hours)
Primary postpartum hemorrhage evaluated by clinical signs, blood loss in mL, hemoglobin and interventions
Time Frame: The length of hospital stay (expected average 72 hours)
The length of hospital stay (expected average 72 hours)
Maternal fever/postpartum infections as evaluated temperature, WBC count, CRP and culture
Time Frame: The length of hospital stay (expected average 72 hours)
The length of hospital stay (expected average 72 hours)
Intrapartum fetal distress as diagnosed by fetal auscultation and electronic fetal monitoring
Time Frame: Duration of labor (maximum 24 hours)
Duration of labor (maximum 24 hours)
birth injuries of the newborn (as reported by physical examination, documentation of birth injuries, and subsequent management )
Time Frame: The length of hospital stay (expected average 1 week)
The length of hospital stay (expected average 1 week)
Neonatal distress "asphyxia" (as reported 1 & 5 minutes APGAR score, resuscitation event, umbilical artery pH, admission to NICU, length of stay and any further medical complications)
Time Frame: The length of hospital/NICU stay (expected average 1 week)
The length of hospital/NICU stay (expected average 1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Sherif AM Shazly, MBBCh,MSc, Assistant lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00008718 - SLiP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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