Labor Scale Versus WHO Partograph in the Management of Labor

Dystocia Clinical Trial

— SLiP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02486822
• Other study ID #: IRB00008718 - SLiP
• Status: Active, not recruiting
• Phase: N/A
• First received: June 24, 2015
• Last updated: May 9, 2016
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dystocia

Intervention

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)

Drug:
• Oxytocin
Oxytocin augmentation: given with further delay of labour (according to the point of intervention of the partograph or the scale)

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

Locations

Country	Name	City	State
Egypt	Assiut Faculty of Medicine - Women Health Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

Amer-Wåhlin I, Hellsten C, Norén H, Hagberg H, Herbst A, Kjellmer I, Lilja H, Lindoff C, Månsson M, Mårtensson L, Olofsson P, Sundström A, Marsál 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. — View 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. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2012;8:CD005461. — View 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. — View Citation

Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8. — View 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. — View 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. — View Citation

Villar J, Valladares E, Wojdyla D, Zavaleta N, Carroli G, Velazco A, Shah A, Campodónico L, Bataglia V, Faundes A, Langer A, Narváez A, Donner A, Romero M, Reynoso S, de Pádua 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. Erratum in: Lancet. 2006 Aug 12;368(9535):580. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time of labor (maximum 24 hours)	No
Secondary	Intrapartum maternal distress (assessed by clinical signs of maternal distress and dehydration)		Time of labor (maximum 24 hours)	No
Secondary	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)	No
Secondary	Primary postpartum hemorrhage evaluated by clinical signs, blood loss in mL, hemoglobin and interventions		The length of hospital stay (expected average 72 hours)	No
Secondary	Maternal fever/postpartum infections as evaluated temperature, WBC count, CRP and culture		The length of hospital stay (expected average 72 hours)	No
Secondary	Intrapartum fetal distress as diagnosed by fetal auscultation and electronic fetal monitoring		Duration of labor (maximum 24 hours)	No
Secondary	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)	No
Secondary	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)	No