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SLiP: Labor Scale Versus WHO Partograph in the Management of Labor

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02486822
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
11
Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Management of Spontaneous Labour in Primigravida (SLiP): Labor Scale Versus WHO Partograph
Study Start Date :
Jul 1, 2015
Anticipated Primary Completion Date :
Jun 1, 2016
Anticipated Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Labor scale

Observation Amniotomy Oxytocin Cesarean Section (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

    • Procedure: Cesarean Section
    Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)
    Other Names:
  • CS

    		•
    Active Comparator: WHO partograph

    Observation Amniotomy Oxytocin Cesarean Section (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

    • Procedure: Cesarean Section
    Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)
    Other Names:
  • CS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported) [Time of labor (maximum 24 hours)]

      The proportion who delivered vaginal versus those indicated for Cesarean Section for labor dystocia

    Secondary Outcome Measures

    1. Intrapartum maternal distress (assessed by clinical signs of maternal distress and dehydration) [Time of labor (maximum 24 hours)]

    2. Intrapartum maternal birth injuries (assessed clinically at the time of labor, the extent and type of repair and subsequent complications will be reported) [Time of labour and hospital stay (expected average 72 hours)]

    3. Primary postpartum hemorrhage evaluated by clinical signs, blood loss in mL, hemoglobin and interventions [The length of hospital stay (expected average 72 hours)]

    4. Maternal fever/postpartum infections as evaluated temperature, WBC count, CRP and culture [The length of hospital stay (expected average 72 hours)]

    5. Intrapartum fetal distress as diagnosed by fetal auscultation and electronic fetal monitoring [Duration of labor (maximum 24 hours)]

    6. birth injuries of the newborn (as reported by physical examination, documentation of birth injuries, and subsequent management ) [The length of hospital stay (expected average 1 week)]

    7. 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) [The length of hospital/NICU stay (expected average 1 week)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut Faculty of Medicine - Women Health Hospital Assiut Egypt 71515

    Sponsors and Collaborators

    • Assiut University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sherif Abdelkarim Mohammed Shazly, M.B.B.Ch, M.S.c, Assiut University
    ClinicalTrials.gov Identifier:
    NCT02486822
    Other Study ID Numbers:
    • IRB00008718 - SLiP
    First Posted:
    Jul 1, 2015
    Last Update Posted:
    May 11, 2016
    Last Verified:
    May 1, 2016
    Keywords provided by Sherif Abdelkarim Mohammed Shazly, M.B.B.Ch, M.S.c, Assiut University
    Labor scale
    Partograph
    Spontaneous labor
    Primigravida
    Additional relevant MeSH terms:
    Dystocia
    Oxytocin

    Study Results

    No Results Posted as of May 11, 2016