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Caesarean Section RateNCT03794063

Analysis of Caesarean Section Rate According to the Robson Classification System

An observational study of Caesarean Section Rate, run by Egyptian Society of Royal College of Obstetricians and Gynaecologists at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Caesarean Section Rate
What is being tested?
Robson 10 group classification system
How many people
3,000 participants
Where
1 siteEgypt
Study dates
10 Mar 2019to 1 Aug 2019
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Women delivering at ≥ 28 weeks gestation

Who cannot join

  • Women delivering at < 28 weeks gestation

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Egyption society of Royal college of obstetricians and gynaecologist

    Cairo

    Bismeen Jadoon, MBBS, 0020 1002557602, bismeen.jadoon@gmail.com

    Amr El Nouri, MD, 00201222146848, amr.elnouri@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Analysis of Caesarean Section Rate According to the 10 Group Robson Classification; A Multicenter Prospective Study in Egypt

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.

Read the detailed description

Increase rate of unnecessary caesarean sections has been a growing concern in most parts of the world. According to the latest survey one in five women in the world now deliver by caesarean section (CS). The Eastern Mediterranean Region (EMR) with its twenty -two Member States (MSs) as classified by the World Health Organization is of no exception in this respect. Within the EMR, Egypt has the highest CS rate of 54%, with no further improvement to maternal and child mortality rates in Egypt, the association of extremely high CS rate and its potential benefits has been questioned. This may suggest that although the necessary numbers of CSs are performed for the population at risk but the rates higher than the recommended threshold (10-15% according to the WHO) could be the measure of unjustified CSs in healthy populations . However, determining the adequate caesarean section rate at the population level - i.e. the minimum rate for medically indicated caesarean section, while avoiding medically unnecessary operations - is a challenging task. Variations in overall CS rate between different settings or over time are difficult to interpret and compare because of intrinsic differences in hospital factors and infrastructure (primary versus tertiary level), difference in the characteristics of the obstetric population (case mix) served (eg % of women delivered by previous CS) and difference in clinical management protocols. This is seen as one of the barriers in better understanding of CS trends and underlying causes. In order to propose and implement effective measures to achieve optimal CS rates, it is first essential to identify what groups of women are contributing the most towards overall CS rate and investigate the underlying reasons for trends in different settings. Like many developing countries, health care facilities in Egypt have no such standardized internationally accepted classification system in place to monitor and compare facility based CS rates in a consistent and action oriented manner.

Policy makers and health organisations have suggested the need for such classification system that can best monitor and compare CS rates in a standardised, reliable, consistent and action-oriented manner. 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. It gives an opportunity to evaluate the prevalence of CSs among various groups of women, to compare data between institutions, learn from each other and to create strategies for better results through audit and feed back cycle. This classification is clinically relevant and categorizes women prospectively which in turns allows the implementation and evaluation of interventions targeted to specific groups. Some studies have shown that if this classification is used on a regular basis, it can provide critical assessment to change the practice.

Aim: The study aim is, to assess, analyse and compare CSR of the participating hospital over the period of three months according to the 10 Group Robson classification system

Participating hospitals

1: Ain Shams University Hospital 4: Mataria Teaching Hospital 4: Shatby Alexandria Hospital 5: Benha University Hospital 6: Ahmed Maher Hospital 7: El-Galaa Hospital 8: Alexandria Hospital 9: Behira Hospital 10:Menia Hospital 11: Luxor Hospital 12: Nada Hospital 13: Rofayda Hospital

Study design: A prospective cross- sectional study will be conducted to implement the Robson Classification within the obstetric department of participating hospitals. The Robson implementation manual will be used as a tool guide for the study.

The study population will include all women with live births and stillbirths of at least 28 weeks gestation at from. Two-study investigator from each participating hospital will be assigned who will provide the ongoing support during the study period. Participants will be invited to attend the introductory workshop for the implementation of the Robson Classification by the study coordinators. Variables necessary to categorise women in to Robson groups will be collected through the predesigned proforma. These variables will be used to classify each woman in to Robson groups with the help of a flow diagram. The collected information will be analyzed on the Excel Sheet to finalize the grouping either manually or by an automatic calculator.The results of each group will be statistically analyzed after entering the data in the report and will be sent on a monthly basis by e-mail or fax to study coordinators.

Being tested
Robson 10 group classification system
Keywords
Robson classification

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robson 10 group classification systemOther

    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.

Study groups in NCT03794063
Study groupRoleWhat they receive
Robson group 1Nulliparous women, single cephalic, more than or equal to 37 weeks, in spontaneous labour
Receives: Other: Robson 10 group classification system
Robson Group 2Nulliparous women, single cephalic, more than or equal to 37 weeks, induced or Caesarean section before labour
Receives: Other: Robson 10 group classification system
Robson Group 3Multiparous women with out a previous Caesarean section , with a single cephalic pregnancy, more than or equal 37 weeks gestation in spontaneous labour
Receives: Other: Robson 10 group classification system
Robson Group 4Multiparous 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
Receives: Other: Robson 10 group classification system
Robson Group 5All Multiparous women with at least one CS with a single cephalic pregnancy, more or equal to 37 weeks gestation
Receives: Other: Robson 10 group classification system
Robson Group 6All nulliparous women with a single breech pregnancy
Receives: Other: Robson 10 group classification system
Robson Group 7Multiparous women with a single breech pregnancy including women with previous Caesarean section
Receives: Other: Robson 10 group classification system
Robson Group 8All women with multiple pregnancies including women with previous Caesarean sections
Receives: Other: Robson 10 group classification system
Robson Group 9All women with a single pregnancy with a transverse or oblique lie, including women with previous Caesarean Section (s)
Receives: Other: Robson 10 group classification system
Robson Group 10All women with a single cephalic pregnancy less than 37 weeks gestation, including women with previous Caesarean section (s)
Receives: Other: Robson 10 group classification system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. caesarean section rate

    absolute and relative caesarean section rate

    Measured: three months

Secondary outcomes (5)
  1. Postpartum haemorrhage

    1. Blood loss of more than 500 mls at vaginal birth
    2. Blood loss of more than 1000 mls at caesarean section

    Measured: from 24 hours to 6 weeks after the delievry

  2. Maternal morbidity

    Admission to Intensive care unit after the delivery

    Measured: 7 days after the delivery

  3. Neonatal morbidity

    Admission of newborn to Neonatal intensive care unit

    Measured: 7 days of the delivery

  4. Maternal mortality

    maternal death from 24 hours to 42 days after the delivery

    Measured: 42 days after the delivery

  5. Neonatal mortality

    death during the first 28 days of life (0-27 days

    Measured: 28 days after the delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2019
  2. Study start10 Mar 2019
  3. Primary completion1 Aug 2019 (estimated)
  4. Study completion1 Aug 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
3,000 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03794063
Sponsor's protocol ID
ERC-RCOG
Status last verified
Jul 2019
First submitted
29 Dec 2018
Last updated
18 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

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

    PubMed 2863457
  • 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.

    PubMed 26849801
  • 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.

    PubMed 21283801
  • 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.

    PubMed 24892928
  • Robson MS (2001) Classification of caesarean sections. Fetal and Maternal Medicine Review 12: 23-39.

  • 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.

    PubMed 23127896
  • 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.

    PubMed 28602031
  • 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.

    PubMed 17324180

Questions about this trial

What is this clinical trial studying?

An observational study of Caesarean Section Rate, run by Egyptian Society of Royal College of Obstetricians and Gynaecologists at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bismeen Jadoon (00201002557602, bismeen.jadoon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

caesarean section rate (time frame: three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03794063, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.

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