Analysis of Caesarean Section Rate According to the Robson Classification System

NCT03794063 | Unknown DMC

• 1 other identifier: ERC-RCOG
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective cross- sectional study will be conducted to implement the Robson Classification to assess, analyze and compare Caesarean section rate of the participating hospital over the period of three months. The Robson implementation manual will be used as a tool guide for the study.

Conditions

Caesarean Section Rate

Keywords

Robson classification

Outcome Measures

Primary Outcomes (1)

• caesarean section rate

  absolute and relative caesarean section rate

  three months

Secondary Outcomes (5)

• Postpartum haemorrhage

  from 24 hours to 6 weeks after the delievry

• Maternal morbidity

  7 days after the delivery

• Neonatal morbidity

  7 days of the delivery

• Maternal mortality

  42 days after the delivery

• Neonatal mortality

  28 days after the delivery

Study Arms (10)

Robson group 1

Nulliparous women, single cephalic, more than or equal to 37 weeks, in spontaneous labour

Other: Robson 10 group classification system

Robson Group 2

Nulliparous women, single cephalic, more than or equal to 37 weeks, induced or Caesarean section before labour

Other: Robson 10 group classification system

Robson Group 3

Multiparous women with out a previous Caesarean section , with a single cephalic pregnancy, more than or equal 37 weeks gestation in spontaneous labour

Other: Robson 10 group classification system

Robson Group 4

Multiparous women with out a previous Caesarean section , with a single cephalic pregnancy, more or equal 37 weeks gestation who had labour induced or were delivered by Caesarean section before labour

Other: Robson 10 group classification system

Robson Group 5

All Multiparous women with at least one CS with a single cephalic pregnancy, more or equal to 37 weeks gestation

Other: Robson 10 group classification system

Robson Group 6

All nulliparous women with a single breech pregnancy

Other: Robson 10 group classification system

Robson Group 7

Multiparous women with a single breech pregnancy including women with previous Caesarean section

Other: Robson 10 group classification system

Robson Group 8

All women with multiple pregnancies including women with previous Caesarean sections

Other: Robson 10 group classification system

Robson Group 9

All women with a single pregnancy with a transverse or oblique lie, including women with previous Caesarean Section (s)

Other: Robson 10 group classification system

Robson Group 10

All women with a single cephalic pregnancy less than 37 weeks gestation, including women with previous Caesarean section (s)

Other: Robson 10 group classification system

Interventions

Robson 10 group classification system OTHER

WHO proposed the Robson classification system as a global standard for assessing, monitoring and comparing caesarean section rates within healthcare facilities over time, and between facilities. It classifies women in 10 groups based on their obstetric characteristics (parity, previous CS, gestational age, onset of labour, fetal presentation and number of fetuses) without needing the indication for CS.

Robson Group 10; Robson Group 2; Robson Group 3; Robson Group 4; Robson Group 5; Robson Group 6; Robson Group 7; Robson Group 8; Robson Group 9; Robson group 1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All women admitted to the labour ward for delivery who are 28 or more weeks of gestation.

You may qualify if:

• Women delivering at ≥ 28 weeks gestation

You may not qualify if:

• Women delivering at \< 28 weeks gestation

Sponsors & Collaborators

• Egyptian Society of Royal College of Obstetricians and Gynaecologists: lead

Study Sites (1)

Egyption society of Royal college of obstetricians and gynaecologist

Cairo, Egypt

RECRUITING

Related Publications (8)

• Appropriate technology for birth. Lancet. 1985 Aug 24;2(8452):436-7.

  PMID: 2863457 BACKGROUND

• Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.

  PMID: 26849801 BACKGROUND

• Torloni MR, Betran AP, Souza JP, Widmer M, Allen T, Gulmezoglu M, Merialdi M. Classifications for cesarean section: a systematic review. PLoS One. 2011 Jan 20;6(1):e14566. doi: 10.1371/journal.pone.0014566.

  PMID: 21283801 BACKGROUND

• Betran AP, Vindevoghel N, Souza JP, Gulmezoglu AM, Torloni MR. A systematic review of the Robson classification for caesarean section: what works, doesn't work and how to improve it. PLoS One. 2014 Jun 3;9(6):e97769. doi: 10.1371/journal.pone.0097769. eCollection 2014.

  PMID: 24892928 BACKGROUND

• Robson MS (2001) Classification of caesarean sections. Fetal and Maternal Medicine Review 12: 23-39.

  BACKGROUND

• Robson M, Hartigan L, Murphy M. Methods of achieving and maintaining an appropriate caesarean section rate. Best Pract Res Clin Obstet Gynaecol. 2013 Apr;27(2):297-308. doi: 10.1016/j.bpobgyn.2012.09.004. Epub 2012 Nov 3.

  PMID: 23127896 BACKGROUND

• Boatin AA, Cullinane F, Torloni MR, Betran AP. Audit and feedback using the Robson classification to reduce caesarean section rates: a systematic review. BJOG. 2018 Jan;125(1):36-42. doi: 10.1111/1471-0528.14774. Epub 2017 Jul 17.

  PMID: 28602031 BACKGROUND

• Chaillet N, Dumont A. Evidence-based strategies for reducing cesarean section rates: a meta-analysis. Birth. 2007 Mar;34(1):53-64. doi: 10.1111/j.1523-536X.2006.00146.x.

  PMID: 17324180 BACKGROUND

Related Links

• Egypt Demographic Health Survey (DHS) , 2014

Central Study Contacts

Bismeen Jadoon

CONTACT

00201002557602; bismeen.jadoon@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research coordinator

Study Record Dates

• First Submitted: December 29, 2018
• First Posted: January 4, 2019
• Study Start: March 10, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 months after the study completed

Locations

EG (1)