Tag Archives: core outcome set

Breech-COS meeting: May 8, 2024

Avni Batish and Kate Stringer, photo by George Haroun

On May 8th, we will be holding an online meeting to establish a consensus on short-term outcomes in our Breech-COS study. We invite anyone with an interest to attend. Book here to attend.

The RCOG training day has been postponed.

Papers to inform the above events:

Walker S, Dasgupta T, Halliday A, Reitter A. Development of a core outcome set for effectiveness studies of breech birth at term (Breech-COS): A systematic review on variations in outcome reportingEur J Obstet Gynecol Reprod Biol. 2021;263:117-126. doi:10.1016/j.ejogrb.2021.06.021

Walker S, Dasgupta T, Shennan A, Sandall J, Bunce C, Roberts P. Development of a core outcome set for effectiveness studies of breech birth at term (Breech-COS)—an international multi-stakeholder Delphi study: study protocol. Trials. 2022;23(1):249. doi:10.1186/s13063-022-06136-9

How it began …

Shawn Walker is funded by a National Institute of Health and Care Research (NIHR) Advanced Fellowship (300582, OptiBreech).

Webinar 30 August 5PM: Testicular complications of vaginal breech birth

Join the webinar using this Zoom link: https://us02web.zoom.us/j/88170521832?pwd=U1RUSzhPNTJ3elVRSFRuL3c2bGszQT09

David Coggin-Carr is a UK+US dual-certified obstetrician, Maternal-Fetal Medicine subspecialist and early career physician-scientist at the University of Vermont (UVM). He practices full-spectrum MFM in Vermont and upstate New York and additionally serve as Associate Medical Director of the Birthing Center and Associate Director of Quality for Obstetrics at UVM Medical Center. In recent years he has developed a strong interest in physiological breech birth in response to the local community’s desire for greater autonomy around their birth choices amidst a near-total lack of trained/experienced providers in the region. Accordingly, he now regularly provides consultations and intrapartum support for planned vaginal breech birth.

Image: Book of Traceable Heraldic Art

All births have the potential for injury, whether this be facial markings from forceps delivery or lacerations from a caesarean birth. Vaginal breech birth has its own variations. This webinar will explore how vaginal breech birth affects neonatal genitals, both normal variations in appearance from being born bottom-first, to potential injuries.

We will also discuss what research on genital injuries should be done, and how these should be measured and reported in clinical trials. This discussion will inform the on-going Breech-COS (core outcome set) in the OptiBreech research programme.

We will discuss and consider the statements:

There should be no requirement to report genital injury as a separate category in ALL effectiveness studies of breech birth at term, although it may be reported in some. It should not be included in the Breech-COS composite measure of severe morbidity.

or

The incidence of significant genital injury, defined as one that is likely to have long-term, life-altering consequences, should be reported as a separate category in ALL effectiveness studies of breech birth at term. Significant genital injury should be included in the Breech-COS composite measure of severe neonatal morbidity associated with vaginal breech birth.

For all sites that have expressed an interest in our planned stepped wedge trial of OptiBreech collaborative care: please include your name and hospital in the chat, and we will award one site selection point for every site that participates.

References

Kekki, M., Koukkula, T., Salonen, A., Gissler, M., Laivuori, H., Huttunen, T.T., Tihtonen, K., 2022. Birth injury in breech delivery: a nationwide population-based cohort study in Finland. Arch. Gynecol. Obstet. https://doi.org/10.1007/S00404-022-06772-1

Habek, D., 2023. Traumatic testicular avulsion during amniotomy in vaginal breech delivery. Eur. J. Obstet. Gynecol. Reprod. Biol. https://doi.org/10.1016/j.ejogrb.2022.12.003

Breech-COS international study

Round 1 of the international multi-stakeholder Delphi study, Development of a Core Outcome Set for Effectiveness Studies of Breech Birth at Term (Breech-COS) is now open. We invite the involvement of anyone from the following stakeholder groups, who has experience of care for women having vaginal breech births:

QR code for Breech-COS Round 1
  • obstetrician
  • midwife
  • service users (you or your partner have had a breech-presenting baby within the last 5 years)
  • neonatologist
  • researcher
  • health services manager
  • healthcare commissioner
  • health economist
  • statistician
  • support group representative
  • other relevant roles

You can read more information about the research and participate using the link or the QR code below. You are welcome to share this post or forward to your stakeholder associates.

Participation Linkhttps://qualtrics.kcl.ac.uk/jfe/form/SV_b4uw2QJxcTC8oZM

This consensus-building activity follows on from our systematic review, including Patient and Public Involvement (PPI) activity, Development of a core outcome set for effectiveness studies of breech birth at term (Breech-COS): A systematic review on variations in outcome reporting.

Shawn Walker, on behalf of the OptiBreech team

Inviting your views … — The OptiBreech Project

From Tisha Dasgupta, OptiBreech Research Assistant, re-blog from The OptiBreech Project: We would like to invite women, birthing people and their families who have experienced a breech pregnancy at term to attend an online focus group discussion on Thursday 10th December 10.30-11.30am to be conducted via Microsoft Teams.  Anyone with an interest and experience of breech pregnancy can participate.

The purpose of this meeting will be to get your perspective on the following issues: 

A core outcome set is a minimum set of outcomes that should be collected in every study about a topic, in this case vaginal breech birth at term. Making these consistent means that we can better compare and combine studies, and ensure research meets the needs of those who use it.

To develop a core outcomes set, we have conducted a systematic review of the available literature relevant to this project (brief summary below). However, we need your input to determine if these outcomes are important to the people who will use the results of research to make decisions, and how important each is. Does this meet all your informational needs or are there outcomes that have not been identified, which you think is important to record? 

Do you think it is important to include salutogenically focused outcomes that emphasize positive well-being of the mother and newborn such as maternal satisfaction, relationship with baby etc.? If so, which factors would you like to see and how important do you think these are? 

The next stage will be to ask both professionals and service users to rate the importance of the outcomes to be included in the core outcome set. But before we do this, we want to insure all of the outcomes important to you are included.

You are welcome to share your feedback directly during the focus group meeting or by emailing Tisha Dasgupta (tisha.dasgupta@kcl.ac.uk), the OptiBreech Research Assistant, at any point. If you are unable to make it and would like to contribute, or have further feedback after the session, please also contact Tisha.

While we do not require written consent for your participation in the meeting, it is important to let you know that the session will be recorded. We intend to take the feedback you provide into consideration while designing the next stage of this project: a multinational Delphi study. No identifiable information will be used such as direct quotes or anecdotes, and we will only report summary data.  

Thank you very much for your consideration. Please could you send your RSVP to tisha.dasgupta@kcl.ac.uk by Monday, 7th December to confirm your attendance at the session? She will be in touch thereafter to provide you access to the online meeting.

More information:

The COMET Database

The CROWN initiative

We’d also love to hear your views on the information presented on the OptiBreech website!


Overall summary of the Systematic Review

A systematic review of all relevant literature was conducted to identify outcomes, definitions and measurements previously reported in effectiveness studies of breech births at term. 108 studies were identified comprising of systematic reviews, randomised controlled trials and comparative observational studies, with full-text available in English. Below are the most common outcome measures, with a percentage of how many studies reported them. These are the top 10 most frequently reported measures in each category grouped by neonatal, maternal, features of labour, and long-term maternal outcomes respectively.

Neonatal outcomes

Outcome measure% studies reported
APGAR score at 5 minutes78.7
Perinatal or neonatal mortality68.5
Admission to neonatal intensive care unit (NICU)59.3
Neonatal birth trauma/morbidity53.7
Brachial plexus injury / peripheral nerve injury38.0
Low umbilical artery pH35.2
Bone fracture33.3
Neonatal seizures/convulsions31.5
Intubation/ventilation29.6
Hematoma (cephalic or subdural)20.4

Maternal outcomes

Maternal mortality24.1
Post-partum haemorrhage (PPH) 16.7
PPH requiring blood transfusion14.8
Other serious maternal morbidity/other complications14.8
Genital tract trauma13.0
Wound infection requiring prolonged hospital stay/re-admission12.0
Deep vein thrombosis (DVT) requiring anticoagulant therapy10.2
Prolonged hospital stay9.3
Hysterectomy8.3
Anaemia7.4

Features of labour

Vaginal Delivery97.2
Emergency Caesarean88.0
Elective caesarean80.6
Induction of labour24.1
Instrumental vaginal delivery18.5
Manoeuvres used17.6
Regional anaesthesia15.7
Trial of labour14.8
Actual mode of birth13.9
Duration of delivery/second stage13.9

Long-term maternal outcomes

Urinary incontinence6.5
Breastfeeding complications5.6
Faecal incontinence5.6
Postnatal depression5.6
CS in subsequent delivery5.6
Long term abdominal pain4.6
Dyspareunia4.6
Flatus incontinence4.6
Relationship with partner4.6
Long term perineal pain3.7