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

Primary Purpose

Dystocia

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Amniotomy
Oxytocin
Cesarean Section
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dystocia focused on measuring Labor scale, Partograph, Spontaneous labor, Primigravida

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Assiut Faculty of Medicine - Women Health Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Labor scale

WHO partograph

Arm Description

Observation Amniotomy Oxytocin Cesarean Section (CS)

Observation Amniotomy Oxytocin Cesarean Section (CS)

Outcomes

Primary Outcome Measures

Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported)
The proportion who delivered vaginal versus those indicated for Cesarean Section for labor dystocia

Secondary Outcome Measures

Intrapartum maternal distress (assessed by clinical signs of maternal distress and dehydration)
Intrapartum maternal birth injuries (assessed clinically at the time of labor, the extent and type of repair and subsequent complications will be reported)
Primary postpartum hemorrhage evaluated by clinical signs, blood loss in mL, hemoglobin and interventions
Maternal fever/postpartum infections as evaluated temperature, WBC count, CRP and culture
Intrapartum fetal distress as diagnosed by fetal auscultation and electronic fetal monitoring
birth injuries of the newborn (as reported by physical examination, documentation of birth injuries, and subsequent management )
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)

Full Information

First Posted
June 24, 2015
Last Updated
May 9, 2016
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02486822
Brief Title
Labor Scale Versus WHO Partograph in the Management of Labor
Acronym
SLiP
Official Title
The Management of Spontaneous Labour in Primigravida (SLiP): Labor Scale Versus WHO Partograph
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystocia
Keywords
Labor scale, Partograph, Spontaneous labor, Primigravida

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Labor scale
Arm Type
Experimental
Arm Description
Observation Amniotomy Oxytocin Cesarean Section (CS)
Arm Title
WHO partograph
Arm Type
Active Comparator
Arm Description
Observation Amniotomy Oxytocin Cesarean Section (CS)
Intervention Type
Procedure
Intervention Name(s)
Amniotomy
Other Intervention Name(s)
Artificial rupture of membranes
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
augmentation of labor
Intervention Description
Oxytocin augmentation: given with further delay of labour (according to the point of intervention of the partograph or the scale)
Intervention Type
Procedure
Intervention Name(s)
Cesarean Section
Other Intervention Name(s)
CS
Intervention Description
Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)
Primary Outcome Measure Information:
Title
Successful vaginal delivery (reporting of whether labor ends in vaginal delivery or Cesarean Section. In case of CS, the indication will be reported)
Description
The proportion who delivered vaginal versus those indicated for Cesarean Section for labor dystocia
Time Frame
Time of labor (maximum 24 hours)
Secondary Outcome Measure Information:
Title
Intrapartum maternal distress (assessed by clinical signs of maternal distress and dehydration)
Time Frame
Time of labor (maximum 24 hours)
Title
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)
Title
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)
Title
Maternal fever/postpartum infections as evaluated temperature, WBC count, CRP and culture
Time Frame
The length of hospital stay (expected average 72 hours)
Title
Intrapartum fetal distress as diagnosed by fetal auscultation and electronic fetal monitoring
Time Frame
Duration of labor (maximum 24 hours)
Title
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)
Title
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif AM Shazly, MBBCh,MSc
Organizational Affiliation
Assistant lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut Faculty of Medicine - Women Health Hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
24835694
Citation
Shazly SA, Embaby LH, Ali SS. The labour scale--assessment of the validity of a novel labour chart: a pilot study. Aust N Z J Obstet Gynaecol. 2014 Aug;54(4):322-6. doi: 10.1111/ajo.12209. Epub 2014 May 17.
Results Reference
background
PubMed Identifier
20334736
Citation
Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8.
Results Reference
background
PubMed Identifier
16753484
Citation
Villar J, Valladares E, Wojdyla D, Zavaleta N, Carroli G, Velazco A, Shah A, Campodonico L, Bataglia V, Faundes A, Langer A, Narvaez A, Donner A, Romero M, Reynoso S, de Padua KS, Giordano D, Kublickas M, Acosta A; WHO 2005 global survey on maternal and perinatal health research group. Caesarean delivery rates and pregnancy outcomes: the 2005 WHO global survey on maternal and perinatal health in Latin America. Lancet. 2006 Jun 3;367(9525):1819-29. doi: 10.1016/S0140-6736(06)68704-7. Erratum In: Lancet. 2006 Aug 12;368(9535):580.
Results Reference
background
PubMed Identifier
17296957
Citation
Liu S, Liston RM, Joseph KS, Heaman M, Sauve R, Kramer MS; Maternal Health Study Group of the Canadian Perinatal Surveillance System. Maternal mortality and severe morbidity associated with low-risk planned cesarean delivery versus planned vaginal delivery at term. CMAJ. 2007 Feb 13;176(4):455-60. doi: 10.1503/cmaj.060870.
Results Reference
background
PubMed Identifier
19330572
Citation
Kjaergaard H, Olsen J, Ottesen B, Dykes AK. Incidence and outcomes of dystocia in the active phase of labor in term nulliparous women with spontaneous labor onset. Acta Obstet Gynecol Scand. 2009;88(4):402-7. doi: 10.1080/00016340902811001.
Results Reference
background
PubMed Identifier
10725495
Citation
Gifford DS, Morton SC, Fiske M, Keesey J, Keeler E, Kahn KL. Lack of progress in labor as a reason for cesarean. Obstet Gynecol. 2000 Apr;95(4):589-95. doi: 10.1016/s0029-7844(99)00575-x.
Results Reference
background
PubMed Identifier
18843690
Citation
Lavender T, Hart A, Smyth RM. Effect of partogram use on outcomes for women in spontaneous labour at term. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD005461. doi: 10.1002/14651858.CD005461.pub2.
Results Reference
background
PubMed Identifier
21250397
Citation
National Collaborating Centre for Women's and Children's Health (UK). Intrapartum Care: Care of Healthy Women and Their Babies During Childbirth. London: RCOG Press; 2007 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK49388/
Results Reference
background
PubMed Identifier
11520523
Citation
Amer-Wahlin I, Hellsten C, Noren H, Hagberg H, Herbst A, Kjellmer I, Lilja H, Lindoff C, Mansson M, Martensson L, Olofsson P, Sundstrom A, Marsal K. Cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram for intrapartum fetal monitoring: a Swedish randomised controlled trial. Lancet. 2001 Aug 18;358(9281):534-8. doi: 10.1016/s0140-6736(01)05703-8.
Results Reference
background
PubMed Identifier
28787749
Citation
Tolba SM, Ali SS, Mohammed AM, Michael AK, Abbas AM, Nassr AA, Shazly SA. Management of Spontaneous Labor in Primigravidae: Labor Scale versus WHO Partograph (SLiP Trial) Randomized Controlled Trial. Am J Perinatol. 2018 Jan;35(1):48-54. doi: 10.1055/s-0037-1605575. Epub 2017 Aug 8.
Results Reference
derived

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Labor Scale Versus WHO Partograph in the Management of Labor

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