Labor Scale Versus WHO Partograph in the Management of Labor

NCT02486822 | Unknown DMC

• 1 other identifier: IRB00008718 - SLiP
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Dystocia

Keywords

Labor scale; Partograph; Spontaneous labor; Primigravida

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• Intrapartum maternal distress (assessed by clinical signs of maternal distress and dehydration)

  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 of labour and hospital stay (expected average 72 hours)

• Primary postpartum hemorrhage evaluated by clinical signs, blood loss in mL, hemoglobin and interventions

  The length of hospital stay (expected average 72 hours)

• Maternal fever/postpartum infections as evaluated temperature, WBC count, CRP and culture

  The length of hospital stay (expected average 72 hours)

• Intrapartum fetal distress as diagnosed by fetal auscultation and electronic fetal monitoring

  Duration of labor (maximum 24 hours)

Study Arms (2)

Labor scale

EXPERIMENTAL

Observation Amniotomy Oxytocin Cesarean Section (CS)

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

WHO partograph

ACTIVE COMPARATOR

Observation Amniotomy Oxytocin Cesarean Section (CS)

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

Interventions

Amniotomy PROCEDURE

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)

Also known as: Artificial rupture of membranes

Labor scale; WHO partograph

Oxytocin DRUG

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

Also known as: augmentation of labor

Labor scale; WHO partograph

Cesarean Section PROCEDURE

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

Also known as: CS

Labor scale; WHO partograph

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Faculty of Medicine - Women Health Hospital

Asyut, 71515, Egypt

Location

Related Publications (10)

• 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.

  PMID: 24835694 BACKGROUND

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

  PMID: 20334736 BACKGROUND

• 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.

  PMID: 16753484 BACKGROUND

• 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.

  PMID: 17296957 BACKGROUND

• 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.

  PMID: 19330572 BACKGROUND

• 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.

  PMID: 10725495 BACKGROUND

• 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.

  PMID: 18843690 BACKGROUND

• 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/

  PMID: 21250397 BACKGROUND

• 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.

  PMID: 11520523 BACKGROUND

• 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.

  PMID: 28787749 DERIVED

MeSH Terms

Conditions

Dystocia

Interventions

Amniotomy; Oxytocin; Cesarean Section

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Labor, Induced; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Sherif AM Shazly, MBBCh,MSc

  Assistant lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.B.B.Ch, M.S.c

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 1, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

EG (1)