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Breech-COS international study launches

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 Link: https://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

We would like to hear from you!

We are in the process of developing the protocol and study materials for Stage 2 of the OptiBreech study which will be a multi-centre prospective observational cohort study designed to support multiple trials of care for women with a breech pregnancy at term. 

In the next phase of our study, we will begin to record outcomes for breech pregnancies and births from several more hospitals across England, Wales and Scotland, on a large database. Personal information, such as names and NHS numbers, will be kept separately from information on the outcomes of pregnancies, so that those who participate are not identified by anyone looking at the data. We will need to collect a lot of data and store it for a long time, so it’s important we get this right. We want to ensure we are providing information about the study in a way that is clear and ethical. 

OptiBreech 2 will involve randomly allocating women to different care pathways, and creating a large scale database of term breech pregnancies for the purposes of 1) establishing safety outcomes in real-world settings and 2) conducting multiple nested trials to establish effectiveness of interventions in the breech care pathway. 

Also, we will be asking some women to allow us to assign them by chance to one treatment or another; this is called ‘randomisation.’ Assigning people by chance enables us to be sure that any differences we see in outcomes are due to the treatment and not something else. For this reason, evidence obtained following random assignment is considered the highest quality evidence. We would like to know how you feel about this and how we are proposing to do it.  

We would like to hear your views on the acceptability of randomisation as well as on the Participant information sheet and Consent forms (linked below).

We’ve created a Participant Information Sheet, with information about the study, and a Consent form, which we would need each participant to sign. We would like to ensure these are clear. And we invite you to tell us if you think we should be doing something differently. 

The meeting will be held on Wednesday 16th June, 11:00–12:00 via Microsoft Teams.  

The link to join: https://teams.microsoft.com/l/meetup-join/19%3ameeting_NjY2YWU3ZGUtYjUwMi00NmQxLWE0ZjMtZGUwMjFlNzRlNmIw%40thread.v2/0?context=%7b%22Tid%22%3a%228370cf14-16f3-4c16-b83c-724071654356%22%2c%22Oid%22%3a%220b7b88cc-f549-43c3-a733-ff811056d022%22%7d

We hope to see you there!

OptiBreech 1 recruitment has begun!

This post explains what this means and what will happen next.

This week, the first woman planning a vaginal breech birth consented to participate in the OptiBreech 1 study.

What does this mean?

The woman requested to plan a vaginal breech birth, and met the criteria, so her care provider spoke to her about the OptiBreech 1 study. After accessing our Information for Women and Birthing People, the woman agreed to have her data contribute to our study. She completed the on-line consent form, and the professional who counselled her completed the consent confirmation form.

What’s going to happen next?

The local Breech Lead makes a plan for how they will provide care for this birth. Ideally, someone who meets all of the OptiBreech Proficiency Criteria will attend the birth. Where this is not possible, the team will do their best to have someone attend the birth who has completed OptiBreech training.

How will they do that?

In this setting, ensuring experienced support is straightforward. The hospital employs a Consultant Midwife with a special interest in breech birth. She meets all of the Proficiency Criteria, and part of her job role is to attend planned vaginal breech births. While she is not paid for additional time on call, her Head of Midwifery has authorised her to claim time back for any birth she attends outside of her normal working hours.

In order to make the service sustainable, the Consultant Midwife will support the clinical staff caring for the woman to gain experience. Her role is to provide an additional layer of OptiBreech support and safety. Where possible, she will seek to involve another member of the OptiBreech team. This is the group of colleagues who expressed an interest in providing OptiBreech care, through the OptiBreech Interest and Proficiency Survey.

What if the Consultant Midwife can’t make it to the birth?

The expectation is that, where possible, a member of the OptiBreech team will be present for all of second stage at a minimum. For planned breech births, there is usually at least a few hours warning, time enough to sort out who is available to attend. All women are informed that there is not an absolute guarantee, and assisted to think through what might happen if no skilled and experienced practitioner is available.

If the Consultant Midwife can’t make it, she will liaise with her colleagues to determine whether someone else on the OptiBreech team is available. If no other skilled and experienced member of staff who has completed OptiBreech training is available, the woman will be informed of this. She will be counselled by the consultant obstetrician on-call and decide if she would like to proceed with a vaginal breech birth or have a caesarean section, just as she would if she were planning a VBB outside of the study.

If this occurs, and nobody who has completed OptiBreech training is available to attend the birth, this will be recorded on the Case Report Form. The research team will be monitoring this closely so that we can give women an accurate idea of how well they can depend on their birth being attended by someone with OptiBreech training.

There is no ‘penalty’ if a participating site is not able to get someone with the OptiBreech training to the birth. Part of what our feasibility testing will determine is how often this occurs. Women in our PPI group expressed understanding that it may be hard for Trusts to guarantee attendance, especially in the early days, but that they appreciated the willingness to try.

What will happen during the birth?

The OptiBreech team member who attends will lead the birth but liaise closely with the on-call consultant obstetrician, as an additional layer of safety. The team will ensure that the Pro Forma is completed, documenting the care around the time of birth.

What will happen after the birth?

The local Principal Investigator will gather the data from the birth and enter it onto a Case Report Form. This will be securely returned to the research team.

If the woman has consented to a follow-up interview or long-term outcome collection, the research team will be in touch as appropriate.

OptiBreech 1: First Steps

Your Research & Development Office have given your site the green light! This post will outline your first steps now that you are starting in the OptiBreech 1 Study.

In accordance with the protocol at site set-up, all sites should:

  1. Provide the OptiBreech research team with a copy of your current guideline covering the management of breech presentation at term, including information provided to women.
  2. Provide us with materials used in mandatory training and any specialist site-specific training, or a brief description. For example, we are interested if your mandatory training uses an in-house package or is based on PROMPT or another training programme.
  3. Please answer: When a woman plans a vaginal breech birth, is it routine to put a plan in place to ensure she has experienced support at the birth, e.g. formal or informal on-call system? (Yes/No)
  4. Liaise with your research team to identify how you will deliver the anonymised data required in the protocol, outlined below.
  5. Make the OptiBreech training available to your staff members. The research team will provide further information on how to do this.

Next Steps

The above information outlines the minimum required for sites who are participating in OptiBreech 1. For sites who are also intending to offer OptiBreech support for planned or unplanned breech births, these are the next steps.

  1. Invite your colleagues to express an interest in delivering OptiBreech care by completing the consent form and survey. This is linked from the top of the Information for Professionals page. (password is available from the protocol or research team)
  1. All staff members supporting OptiBreech births need to have completed the OptiBreech Training, also available from the Information for Professionals page. (password is available from the protocol or research team)
  1. On-line participant Information Sheets and Consent Forms are all linked from the Information for Women and Birthing People page. (password is available from the protocol or research team — the research team are happy to run through this process with you whenever you like, so do not hesitate to be in touch)

Accruals

In this study, the following count as accruals:

  1. recruitment of women who are planning a vaginal breech birth with OptiBreech support;
  2. recruitment of women who have had an unplanned vaginal breech birth with support from the OptiBreech team;
  3. interviews with health care professionals who have been involved directly or indirectly with care for women recruited to the study.

Because of the importance of developing services slowly and carefully where vaginal breech births have been rare in the past couple of decades, we have enabled sites to access the enhanced training in exchange for anonymised, retrospective data only; however the return of this data will not count as an accrual. There is no minimum recruitment target, though we may seek to interview key staff about their feelings of readiness / willingness to support planned vaginal breech births or to develop a proficient team.

Undiagnosed breech births in the OptiBreech 1 Study

How can women with an undiagnosed breech birth participate in the OptiBreech Study? This post covers the process.

The short answer: How does it work?

Image courtesy of Dr Anke Reitter, Frankfurt
  1. If staff feel it is in the woman’s best interests to call someone to the birth who has completed the OptiBreech training and/or achieved the proficiency criteria, then they should do so.
  2. When the breech presentation is diagnosed, staff should determine if there is someone available who has completed the enhanced training and/or meets the proficiency criteria, who can attend and support the birth. You can download a Breech Birth Pro Forma to assist with collecting all of the data we need about the birth.
  3. If someone with OptiBreech training has attended the birth, the woman may be approached after the birth and asked for her consent for her data to be used in the study, as per the standard consent procedures. The person has the right to decline use of their data. The Participant Information Sheet and Consent Form are linked from this page (including a video version of the PIS). The password for the on-line Consent Form (preferred) is available from your local Principal Investigator.
  4. Consent should be sought by someone who attended the birth, and they should also offer a thorough debrief of what happened at the birth at this time.

The longer explanation

In OptiBreech 1, we are collecting prospective observational data on planned vaginal breech births, where women and birthing people consent to our use of this data. This will include rates of vaginal birth and adverse outcomes for babies (death or admission to the neonatal unit) and mothers (PPH, severe perineal tears). We will also be looking at how many women plan a vaginal breech birth, and how many are attended by someone who has attended OptiBreech training and/or maintained proficiency-level experience. This will enable us to calculate whether a large trial will be possible.

Many participating sites are just beginning to re-build a breech birth service after decades of not offering such a service. Where overall experience levels are low, some Trusts are expecting to start out with mainly ‘undiagnosed breech births.’ This refers to a situation where the breech presentation is identified for the first time after the person has been admitted in labour. Approximately 20-30% of breech presentations are diagnosed for the first time in labour, or 5% where universal third trimester scanning has been implemented (Salim et al 2021).

The benefit-risk balance of vaginal birth vs caesarean section is altered when a woman is in labour. The findings of the Term Breech Trial indicated that a caesarean section performed prior to the start of labour significantly reduces risks to the baby compared to a vaginal birth (when the classical methods of delivery used in the TBT are used, Su et al 2003). This effect was less significant in early labour but still clear. However, when the woman was in active labour, defined as 3 cm or more, the benefit was less clear and did not reach statistical significance.

A potential benefit from a CS in labour needs to be balanced against known risks to the woman and future pregnancies. Although most women are very willing to sacrifice themselves for any benefit to their baby, a CS performed near to or in the second stage of labour also significantly increases the risks of early preterm birth and late miscarriage in all future pregnancies (Watson et al 2017).

Although many clinicians will still want to offer women a CS if they feel they have time to counsel appropriately, because of the change in benefit-risk balance in labour, the RCOG guideline currently advises that women near to or in the second stage of labour should not routinely be offered a CS. Women in our PPI group also tell us that being asked to decide on the mode of birth for a breech baby in labour, where there is no immediate threat to fetal well-being, is very stressful and can result in birth trauma, even where outcomes are good (Lightfoot 2018).

The OptiBreech study is designed on the premise that getting someone to a vaginal breech birth who has 1) completed an enhanced, evidence-based training package; and/or 2) has acquired proficiency-level experience, is likely to improve the outcomes of both planned and unplanned breech births. Therefore, we have worked into the protocol a way of enabling women with a breech presentation diagnosed in labour to participate, taking account of the RCOG guidance for obtaining valid consent to participate in perinatal research where consent is time critical (2016, see also Vernon et al 2006).

Women in our PPI group expressed that taking consent for participation in labour was not appropriate. As this is an observational, rather than interventional, stage of the study, and attendance of an OptiBreech-trained professional would be something in addition to, rather than replacing, standard care, they felt it was appropriate that women’s consent be taken retrospectively in the postnatal period. Standard counselling about mode of birth, according to RCOG guidelines, would apply in labour.

Women also identified that many found the experience of undiagnosed breech birth traumatic regardless of the outcome, due to the concern staff expressed when discovering their baby to be breech. However, they were rarely offered an opportunity to process what had happened with staff who were present. PPI participants said they felt women would benefit from careful explanations in the postnatal period. We therefore added the last step. We are grateful for the guidance of our PPI group, so that we can make participation in OptiBreech 1 potentially beneficial for women, rather than a burden.

If you have any comments to make about this process, you are welcome to leave them here or contact the research team.

Saturday at 2pm: Consultation on Draft NICE Antenatal Care Guideline — Breech Birth Network

You are invited to an open discussion about the Draft of the new NICE Antenatal Care Guideline. Breech Birth Network would like to collect the views of families who have experienced a breech presentation at term and care providers on the draft guidance. Josephine and Thiago talk about their experience of Ulysse’s breech birth at…

Saturday at 2pm: Consultation on Draft NICE Antenatal Care Guideline — Breech Birth Network

Inviting your views …

We invite participation in an on-line PPI (patient and public involvement) meeting to be held on the 10th of December.

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

The proposal

This research is funded by an NIHR Advanced Fellowship. The entire process took about 2 years, from the early stages of writing (2018) to the time the fellowship began (2020). The final design of the research was influenced by further PPI work with service users and professionals in participating sites.

Plain English Summary

Most babies are born head-first (cephalic), but about 1 in 25 are in a bottom-down position (breech) after 36 weeks of pregnancy, and some are not detected until labour. These babies have some increased risk around the time of birth, so most are born by caesarean section. However this is also associated with some risks for the babies, for mothers and for future pregnancies. Mode of childbirth is a very personal decision.

Women who have experienced breech pregnancies have asked for:

  • more information about non-caesarean options; and
  • reliable support from an experienced midwife or obstetrician if a vaginal birth is planned.

These requests align with national policy to enable maternal choice.

The Royal College of Obstetricians and Gynaecologists guideline indicates that with experienced attendants, a breech birth may be almost as safe as a cephalic birth. A package of care known as ‘physiological breech birth’ (PBB) may further reduce birth-related risks for the baby and increase the chance of a vaginal birth.

PBB care includes:

  • specialist team leadership,
  • evidence-based training, and
  • an active birth approach, including the mother’s choice of birthing position.

Previous research shows all three elements are necessary parts of the intervention.

We do not know whether PBB is as safe and cost-effective as standard care for breech presentation at the end of pregnancy. One way to find out is by a clinical trial, to compare outcomes in women who have standard care with those who have physiological breech care.

Some important questions must be answered first to design a successful large-scale trial. This is called a ‘feasibility study.’ The questions include:

  • What outcomes are most important to women and professionals? An agreement on what should be measured will be developed using on-line surveys with women and experienced professionals. The main outcomes being considered are: admission to the neonatal unit, vaginal birth, known caregiver in labour, satisfaction with care, whether everyone has the same access (equity), health service use and quality of life outcomes, for 2 years after birth.
  • How many women might wish to take part in a large trial? To predict this accurately, we will run a small version of the trial, aiming to recruit 100 women within four maternity units in South London.
  • Can we collect all of the information we need, and how much time does it take? We will describe how much can be obtained from routinely collected data and how much needs to be asked of women and staff.
  • How do women and staff feel about the interventions we are comparing? We will use surveys and interviews to collect views about the acceptability of PBB and standard care.
  • How much does it cost to provide PBB care, compared to standard care? We will collect information about costs of providing care and how they are measured, so a large trial can determine if PBB represents good value for money.
  • How many sites across the UK would be willing and able to participate in a full trial? We will survey all UK maternity units.
  • Is a full trial likely to succeed?  The information gathered in this feasibility study will help us to predict whether enough women might take part, and whether women and staff would find the PBB service acceptable if used more widely in the NHS following a trial.

International Collaborators

An initial objective of this research is to develop a core outcome set for effectiveness trials of vaginal breech birth (COMET). Establishing a core outcome set enables the results of trials to be combined and compared in meta-analysis and gives us a way to judge the effectiveness of interventions across settings.

If it does not prove feasible to conduct a randomised trial, a different design may work better. For example, a large prospective observational study, using the same core outcome criteria. While many sites within the UK are implementing physiological breech birth, many successful early adopters are outside of the UK. Collaborating with them will enable each of us to demonstrate local results, and to identify the incidence of rarer outcomes such as perinatal morbidity and mortality (death or serious illness around the time of birth).

Therefore I am proceeding with both potential projects in mind, so that the work has a flexible back-up plan for providing the answers that women and health care professionals want about physiological breech birth. I have applied for a smaller grant, which would fund the outcomes consensus project and creation of an on-line database, to which collaborators anywhere in the world could contribute once local approvals are obtained. If both applications are successful, the international prospective observational study would provide evidence of the generalisability of any results we see within the UK study.

International collaborators who have agreed to lead data collection in their countries are:

  • Germany — Dr Anke Reitter, Chief Obstetrician, Krankenhaus Sachsenhausen, Frankfurt
  • Australia — Dr Andrew Bisits, Director of Obstetrics, Royal Hospital for Women, Sydney
  • Denmark — Dr Kamilla Gerhard-Nielsen, Obstetrician, Syghus Sønderjylland, Aabenraa
  • Netherlands — Dr Floortje Vlemmix, Amsterdam Universitair Medische Centra; and Dr Leonie van Rheenan-Flach, OLVG West, Amsterdam
  • Sweden — Dr Julia Savchenko, Obstetrician, Södersjukhuset, Stockholm
  • Canada — Jane Wines, Midwifery Lecturer, University of British Columbia
  • Ethiopia — Kidist Eshetu Berhahu, Hawassa College of Health Science, Ethiopia; and Shimeles Tsegaya Tessema, Dilla University
  • Hungary — Dr Zoltan Kovacs, Obstetrician, Robert Hospital, Budapest
  • Brazil — Professor Melania Amorim, Senior Researcher & Obstetrician, Instituto Paraibano de Pesquisa Professor Joaquim Amorim Neto (IPESQ) and Dr Priscila Ribeiro Huguet, San Paolo
  • Belgium — Dr Caroline Daelemans and Dr Sara Derisbourg, Erasme Hospital, Brussels
  • India — Dr Evita Fernandez and Indie Kaur, Fernandez Hospital Foundation, Hyderabad
  • United States — Dr Emiliano Chavira, St Francis Medical Centre, and Dr Annette Fineberg, Sutter Davis Medical Centre, California, USA
  • Spain — Carmen Medina Mallen, Hospital de Sant Pau, Barcelona

If you are potentially interested in collaborating in this project, please contact me via the form below.

PPI with professionals around the UK

Each time I teach the Breech Birth Network Physiological Breech Birth Study Day, I explain the feasibility study and trial I am hoping to do and invite feedback from those attending. Below are examples of feedback from around the UK:

  • London, May 2019 — St Thomas’ Hospital
  • Ormskirk, Lancashire, August 2019 — Edge Hill University
  • London, October 2019 — St Thomas’ Hospital
  • Hayward’s Heath, December 2019 — Princess Royal Hospital

Some surprising feedback in a recent meeting with the Lead Obstetrician and Director of Midwifery in one of the South London teaching hospitals who are not currently planning to participate in the randomisation element of the feasibility study. This hospital is further along implementing a breech clinic and some on-call element to support physiological breech births. Because of this, they feel it might be unethical to randomise women to ‘standard care,’ as outlined in the Description of Intervention. They will still be participating in the implementation evaluation aspect of the feasibility study. I and the Steering Group will be considering this and feedback from other Trusts when deciding if the final design should be modified in a larger study.