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Abstract

Background:

Intrapartum research (occurring during labour and birth) presents challenges to successful recruitment to clinical trials. These include limited time for discussion, decision-making for two (mother and baby), heightened emotional states (pain, anxiety and/or fatigue) and clinician hesitancy to discuss research in this setting. In the context of the Baby head ElevAtion Device Feasibility Study, where the event of interest (caesarean section at full dilatation) is both rare (fewer than 3% of all births) and unpredictable, we undertook a mixed-methods evaluation of the two-stage consent process: (1) abbreviated intrapartum consent and (2) full postpartum consent. The aim was to explore whether abbreviated intrapartum consent was acceptable to patients and clinicians.

Methods:

Eligible patients approached at full cervical dilatation (10 cm) to take part in the Baby head ElevAtion Device Feasibility Study were invited to complete a face-to-face survey of their experience of consent within 3 days after birth. We sampled those who consented and those who declined the study. Clinicians working at recruitment sites were invited to an individual semi-structured interview. Qualitative data were analysed using reflexive thematic analysis.

Results:

Over 12 months, 69% (128/186) of eligible patients consented to the Baby head ElevAtion Device Feasibility Study; 87% of consenters and 66% of decliners completed a follow-up survey. Most survey responders (78%) and clinicians found abbreviated intrapartum consent acceptable. Three themes shaped patient decision-making: perceived benefits, trust in healthcare, and feeling overwhelmed. Those who declined often wished they’d had more time or earlier information. Clinicians found the two-stage consent process feasible and appropriate for low-risk interventions, although time pressures and communication challenges affected consent quality. Many saw the model as respectful of autonomy and potentially useful for future intrapartum research.

Conclusion:

Our findings suggest that the two-stage consent process for this intrapartum study was acceptable to both patients and clinicians. We propose this as a useful consent model for peripartum studies where the clinical situation occurs infrequently, the intervention being studied is low risk, and where opt-out or deferred consent is not available.

Keywords

Consent intrapartum consent abbreviated consent emergency research obstetrics caesarean section clinical trial

Background/Aims

Approximately half of all clinical trials fail to meet recruitment targets, and reasons for this are often multi-factorial.^1,2 This has both ethical and financial implications and the potential to delay implementation of important clinical practices or treatments.^3–5 Pregnant people invited to participate in research have the additional burden of considering the benefits and risks for both themselves and their baby. Research conducted in the intrapartum period (during labour and birth) adds challenges to recruitment including limited time for discussion and decision-making. Unexpected events in labour can add stress for families, and patients may be fatigued, distressed and in pain.^4,6 Clinicians may feel hesitant to approach patients about research in these situations due to competing clinical demands, concerns about the patient’s vulnerability, and the potential risks or uncertainties associated with the proposed treatments.⁷ Understandably concerns have arisen about whether informed consent is possible in this context.⁸

Historically, ethical committees have been directed to consider pregnant people as ‘vulnerable’. It is possible that this view has led to a lack of advancement of the science around perinatal interventions and an underrepresentation of pregnant people in research.^6,8,9 There is no evidence that pregnant people lose capacity to consent for research. Moreover, they are required to consent to a range of tests and procedures during the antepartum and intrapartum period. Previous research has identified that pregnant people value the opportunity to participate in research, and evidence-based medicine is important to providing high-quality intrapartum care.^10,11

For these reasons, the clinical setting in which a trial is undertaken is crucial to the development of a suitable consent process.¹² While studies have looked at patient and/or clinician experience of consent in emergency settings, few have looked at maternity care specifically, and those that have present differing views on a recommended consent pathway.^6,7,12–14

The Royal College of Obstetricians and Gynaecologists (RCOG) have produced guidance around obtaining valid consent for perinatal research where consent is time critical. This guidance considers oral consent in acute settings, followed by written consent when the situation allows, to be appropriate when the event is rare.¹⁵ In the New Zealand setting, modifications to the standard consent process (e.g. opt-out, abbreviated or deferred consent) are considered on a case-by-case basis by ethics committees but are uncommonly used in maternity research.¹⁶

The Baby head ElevAtion Device (BEAD) Feasibility Study was a double-blinded randomised controlled trial with patients becoming eligible for enrolment to the study in labour when their cervix was fully dilated, and there was a recommendation for the baby to be born by caesarean section. As a caesarean section at full dilatation (CSFD) is difficult to predict and occurs in fewer than 3% of all births, we obtained ethical approval to undertake a two-stage consent process using initial abbreviated intrapartum consent and full postpartum consent after the intervention. This Study Within a Trial (SWAT) aimed to better understand the patient and clinician experience of an approach to participate in a study using a two-stage consent process.

Methods

The research setting

New Zealand has a publicly funded, midwifery-led maternity care system. Most pregnant people receive continuity of care from a community-based lead maternity carer, typically a midwife. Maternity care is free for eligible residents and includes antenatal, labour and birth, and postnatal care. Those with complexities during pregnancy, labour and birth or postpartum receive additional care from hospital-based obstetric and midwifery teams.

The BEAD Feasibility Study was a randomised controlled trial assessing the feasibility of recruitment to a larger trial (BEAD Study) investigating the use of a head elevation device (the Fetal Pillow^®) at CSFD.¹⁷ The Fetal Pillow^® is a small, inflatable silicone balloon inserted into the vagina under the baby’s head immediately prior to CSFD and inflated with 180 mL of saline. It is marketed to elevate the baby’s head out of the pelvis despite a lack of high-quality evidence for its effectiveness and is commonly used worldwide at surgeon discretion.^18,19

Over 1300 births within retrospective studies and one small randomised controlled trial (RCT) have been reported in the literature with no documented complications. The absence of reported harm supports the classification of this study as low risk, with no added risks beyond standard clinical care. The study took place at two major tertiary maternity hospitals in Auckland, New Zealand (Auckland City and Middlemore Hospitals).

Consent process for BEAD Feasibility Study

The BEAD Feasibility Study used a two-stage consent process approved by the ethics committee, designed to accommodate the urgent nature of CSFD. Information was made available during pregnancy via a study website, patient brochures and posters in antenatal clinics and around the hospital. Patients were still eligible if they had not seen this prior to labour.

Stage 1: Abbreviated intrapartum consent

Eligible patients (aged ≥16 years, with a live, singleton, cephalic pregnancy at ≥37 weeks’ gestation) were invited to take part in the study. Intrapartum consent was sought at the time of surgical consent for CSFD. Depending on randomisation, the device was inflated with 180 mL of saline or sham-inflated, with both patient and surgeon blinded to allocation.

A study-specific standardised script (Supplementary File 1), designed to take approximately 1–2 min to read aloud, was used alongside verbal explanations and written materials to provide essential information about the intervention while minimising cognitive burden during labour. The time available for patients to decide about participation varied by clinical urgency; typically, patients had up to 60 min, while those requiring urgent Category 1 CS were often not approached. Both the patient and the clinician obtaining consent signed the abbreviated consent form to document agreement.

All clinicians involved received training and resources on the consent process, including an instructional video and written guidance, to ensure consistent and ethically sound communication. A midwife was present with patients during the intrapartum consent discussion, serving as an advocate and providing support.

Stage 2: Postpartum full consent

Following delivery, participants were re-approached by research staff to reaffirm their consent for the intervention, which was a one-off procedure, and to obtain additional consent for the collection of maternal, neonatal and future pregnancy data. This process used the standard Health and Disability Ethics Committees consent form and patient information sheet, allowing participants to ask questions and withdraw from the study at any time without affecting their clinical care.

Sample and recruitment

Patients

Recruitment for the BEAD Feasibility Study occurred at both hospital sites over 12 months. Patients who consented or declined during labour were approached, before discharge, to complete an opt-in consent experience survey co-developed with consumers, research staff, obstetricians and midwives (Supplementary File 2). Those who gave abbreviated intrapartum consent were approached shortly after giving full postpartum consent, while decliners were approached if research staff were available, leading to a lower approach rate.

Clinicians

Between February and July 2024, clinicians at both recruitment sites were invited via email to participate in semi-structured interviews exploring barriers and enablers to recruitment to the BEAD Study. Purposive sampling was used to include clinicians who actively recruited patients in labour and those who were more hesitant to approach patients. Those who agreed were sent a participant information sheet and consent form, and interviews were undertaken by an independent clinician.

Data collection

Patients

Patients were invited to complete the short, face-to-face consent experience survey with a member of the research team. Patients were often with family during the survey, and this was supported by the research team. Data collection took place between 14 August 2023 and 5 August 2024. The survey included a combination of open and closed questions (using Likert-type scales) about the experience of intrapartum consent (Table 1). De-identified survey responses were recorded directly into a REDCap database hosted by the University of Auckland.²⁰ Demographic details and the number of eligible patients in the time frame (to calculate the proportion of those eligible who were approached or recruited to the BEAD Feasibility Study) were obtained from the study screening log.

Table 1.

Topics explored in patient consent experience survey and clinician interviews.

Patient survey – areas of questions explored	Clinician interview – topics related to consent
Recall of antenatal information about the BEAD Study	Timing of approach for participation (intrapartum)
Experience of abbreviated intrapartum consent used in the BEAD study	Experience of approaching patients in labour
Provision of information (format, quality, timing)	Perception of consent pathway (two-step process)
Factors influencing decision to participate or not participate in the BEAD study	Quality of intrapartum consent
Changes to make future participation more likely (for those who declined)

Clinicians

Topic guides for the semi-structured interviews were developed, then piloted and conducted via Zoom using a clinician independent of the study team. Interviews were recorded, and study transcripts were checked for accuracy and anonymised.

Data analysis

Quantitative questions were analysed descriptively, and statistical comparisons were made using chi-square tests. Some responses were combined for statistical testing, and denominators varied excluding unanswered questions.

Reflexive thematic analysis was used for qualitative data and highlights the researcher’s active role in knowledge production.²¹ We used a collaborative approach between three co-authors (J.W., R.C. and E.B.) to ensure a rich and ethnically appropriate interpretation of the data.²² All data were read by J.W. and R.C. to allow familiarisation before using Microsoft Excel and NVivo version 12, to organise codes and develop themes using an inductive approach. EB (Ngāti Awa, Te Ātiawa ki Whakarongotai, Te Arawa and Ha’ano (Tonga)) provided a Māori (indigenous peoples of Aotearoa New Zealand) perspective and allowed us to explore responses from the sub-group of Māori patients, to support our consent approach being culturally appropriate. Coded data sets were subjected to further, in-depth analysis to identify additional themes and illustrative quotations. Quotes from survey participants (P) are coded (e.g. P12C, with C indicating consent for the BEAD Feasibility Study and D indicating decline) and clinician quotes DR for doctor and MW for midwife. Reflexivity was used throughout data analysis and collection as a methodological tool to enhance the credibility of the findings.²³ Ethical approval for the Feasibility Study and the qualitative research was given by Northern A Health and Disability Ethics Committee, New Zealand (2023 AM 15526).

Results

Over 12 months, 186 patients were approached to participate in the BEAD Feasibility Study, of whom 128/186 (69%) consented. A greater proportion of those who consented to the BEAD study (111/128, 87%) completed the survey, compared to those who declined to take part (38/58, 66%) (Figure 1). Two people who provided intrapartum consent did not reaffirm consent for the trial when seen postpartum, both declining for data privacy concerns.

Figure 1.

Flow chart relating to patient experience survey for those approached about the BEAD Feasibility Study in labour.

Survey responders were representative of the ethnic groups of those eligible for the BEAD Feasibility Study (Table 2). The quantitative elements of the patient experience survey are summarised in Table 3 along with illustrative comments. Most participants received verbal information and felt it was sufficient to make a decision; however, those who declined participation were significantly less likely to recall being approached and more likely to want information at an earlier time. Differences were also noted in perceptions of information adequacy between consenters and non-consenters (Table 3).

Table 2.

Patient survey responders compared to patients eligible for the BEAD Feasibility Study, by ethnicity.

	Survey participants		Eligible for BEAD Feasibility Study
	n =	149	n =	363
	n	%	n	%
Ethnicity
Indigenous/Māori	12	8	24	7
Pacific	19	13	52	14
Indian	60	40	129	36
Other Asian	22	15	62	17
European/MELAA/not stated	36	24	96	26

MELAA = Middle Eastern, Latin American, African.

Table 3.

Patient survey findings by consent status among responders.

	All responders		Agreed to take part		Declined			Illustrative comments
	n =	149	n =	111	n =	38	p
	n	%	n	%	n	%
Ethnicity
Indigenous/Māori	12	8	9	8	3	8
Pacific peoples	19	13	13	12	6	16
Indian	60	40	46	41	14	37
Other Asian	22	15	14	13	8	21
MELAA (6)/European/not stated (2)	36	24	29	26	7	18	0.6
Care giver in pregnancy
Self-employed community midwife	102	68	81	73	21	55
Private obstetrician	4	3	4	4	0	0
Hospital primary care	43	29	26	23	17	45	0.03
Did you hear about the BEAD study during your pregnancy?	11	7	10	9	1	3	0.3	‘It is new to me and I [hadn’t] heard of it’ (P62D)
No	136	91	100	90	36	95
If yes, how?
Lead maternity carer	0	0
Social media	2	1
Antenatal clinic	0	0
Friends/other pregnant parent	2	1
Other (poster in toilet, poster in atrium (2), not sure, flyer, clinician went to education, used to work in research in India, aware of previous research)	7	5
Had you seen any posters or social media posts?
Yes	19	13	16	14	3	8	0.3
Do you remember anyone asking you if you wanted to take part?
Yes	139	93	110	99	29	76		‘I remember Dr. [Y] explained it to me. There were a lot of people telling me about this Fetal Pillow^®. I loved what they told me at the time.’ (P72C)
No	10	7	1	1	9	24	< 0.001
In labour how did you get the information?	n =	139	n =	110	n =	29
Verbal	134	96	107	97	27	93	0.3	‘Verbal was good had the opportunity to ask questions.’ (P102C)
Written	39	28	30	27	9	31	0.7	‘The information pamphlet is very confusing … I read it but I still need doctor to explain to me.’ (P110D)
Visual (e.g. video)	6	4	5	5	1	3	0.8
Would you have preferred a different format?
Yes** (see qualitative responses – email, video, earlier (3), see the balloon (1), antenatal or during induction (2))	20	14	13	12	7	24	0.09	‘Video would be really helpful to visualise.’ (P84D)
No	119	86	97	88	22	76
Was the information you received enough to make a decision about taking part?								‘I think information is enough for me because I just need to know about the key information.’ (P57C)
Enough	108	78	94	85	14	48		‘They only talked to me about this study, no video. It was quite helpful, information was enough.’ (P106C)
Not enough	20	14	11	10	9	31
Too much	5	4	3	3	2	7	0.002	‘Not really. I was in pain so when he asked me about this study I said no. I’m not too sure whether information was enough because I was not listening.’ (P68D)
Did not answer	6	4	2	2	4	14
Would you have preferred to receive this information at another time?
Yes	56	40	36	33	20	69		‘To be asked earlier and have time to understand information.’ (P95D)
No	82	59	73	66	9	31	< 0.001	‘Yes, but in the circumstances it was good enough to help make the decision … Especially as I was upset about the caesarean, the amount of information was comfortable.’ (P92C)
Did not answer	1	1	1	1

MELAA = Middle Eastern, Latin American and African; P = patient number; D = declining patient; C = consenting patient.

We asked patients who responded to the consent experience survey but had declined intrapartum participation in the BEAD Feasibility Study, if there was anything that could be changed that would make them more likely to participate if asked in a future pregnancy. Twenty-four of the 38 survey responders provided a comment, and many brought up the timing of information:

Knowing ahead of time. Before the pain. Nothing else, just the timing or when still pregnant. Coming for my appointments would like my midwife to tell me about it and we could have done our own research on it. (P122D)

Another patient pointed out that:

Would have been good to have had the information earlier and not during a vulnerable moment just before CS, as difficult to make a decision when you’re on drugs and being given so much information during a situation like that. (P143C)

We asked all survey responders how it felt to be asked about the study in labour and what were the reasons they chose to take part or not take part in the BEAD Feasibility Study. Three overarching themes (each with two sub-themes) were developed from the data that provided insight into their decision-making: (1) benefits of participation, (2) trust in healthcare and (3) overwhelmed in the moment (Table 4).

Table 4.

Patient barriers and enablers to participation in clinical trial when approached in labour.

Theme 1 – Benefits of Participation
Subtheme: Opportunity to help self and/or baby
‘It sounded beneficial to baby, and it was a no brainer.’ (P92C)
‘Clearly explained and may be beneficial for baby.’ (P48C)
‘Just [wanted] to get her out. Midwife said it would make it easier so when I heard that I said OK.’ (P42C)
‘I think this device may help me out because they told me my baby’s head was very down.’ (P80C)
Subtheme: Altruism
‘I had no qualms being asked. It always feels good being asked about something that betters understanding medically or scientifically.’ (P2C)
‘I’m a researcher and I have to recruit participants. Medical science research is my jam, and I wanted to help in some way.’ (P141C)
‘Always happy to be part of research or something medical related. Anything to help future mum’s and generations.’ (P117C)
‘Because I have medical background. I know it is important to have evidence based research.’ (P11C)
Theme 2 – Trust in healthcare
Subtheme: Trust in clinicians
‘Because I felt safe to join and [understood] what the doctor was going to do [because of] how the doctor explained to us. We felt good to join it. And you guys need to know about whether it is working or not.’ (P34C)
‘I was unsure about this study but my midwife reassured me … she encouraged me to participate in this study.’ (P67C)
‘At the time was too much because I used Entonox gas. but Dr. [X] was very good, she gave me time to think about it and allowed me to say no.’ (P104D)
‘I trust my obstetrician…wouldn’t present an option that would be bad, if it helps other mums why not, well presented by Dr [X], well-articulated.’ (P26C)
Subtheme: Trust in the device (Fetal Pillow^®)
‘My midwife … is from UK and she told us they had been using Fetal Pillow a lot in UK so she reassured us it was not a big deal.’ (P125C)
‘Because I want the doctor to use the device.’ (P21D)
‘Because I wanted to stick to the main parts of the birth.’ (P35D)
‘Honestly, it was a very positive experience. I’d rather have a Fetal Pillow than human fingers. The doctor was really nice and showed my partner the device.’ (P34C)
‘I was not familiar with it and I just didn’t fully understand that. I was scared when they told me they wanted to put some balloon in and push the head up. It sounded very scary to me. I said no because I didn’t want the Fetal Pillow^® to be used on me.’ (P104D)
Theme 3 – Overwhelmed in the moment
Subtheme: Initial reaction
‘Do we really want to do it? A bit guinea-pig like initially, then we understood what it was about. Medicine [is] only going to improve if we participate in these sorts of things.’ (P89C)
‘At first I was worried only because I didn’t expect to go through caesarean. I was thinking not of the benefits but of the risks. When the doctor explained it more and more, I was satisfied to help me and my baby and help other women. Best to explain while we are in the situation … I wouldn’t be interested to hear in pregnancy as didn’t think it would happen to me.’ (P126C)
‘Initially a bit taken aback and thought about saying no as had been through a lot already. Excited to be asked about being in a study as had missed out on other opportunity. Glad to have found a study. Doctor said it might help.’ (P141C)
Subtheme: Needed more time
‘Already many confusing and new things happening. For example: waters broke and not planning to have baby today. I am someone who thinks thrice about things. I wanted a vaginal delivery. It was the wrong time, not ready to think.’ (P105D)
‘Overwhelming in that moment, I didn’t mind being part of it but if I had more time to think about it…’ (P84D)

P = patient number; D = declining patient; C = consenting patient.

Benefits of participation

For self and/or baby

For those survey responders who chose to take part in the study, they commonly reported they were ‘happy to join’ and ‘give it a go’ and thought it would be ‘helpful’ or ‘beneficial’ either for their situation (needing a caesarean section in advanced labour) and/or for their baby. Clear explanations from clinicians about the relevance of the study were also important in their decision to take part.

Altruism

Other survey responders recognised an opportunity to make a difference to mums and babies in the future as well as appreciating the importance of research in women’s health. Despite the timing of discussion about this study (in advanced labour), for many, a combination of benefits for self and/or baby and of altruism was the motivation for their participation. ‘Made me feel like I was not only helping myself but potentially doing greater good. Happy to be asked’ (P41C).

Trust in healthcare

In clinicians

For those that consented to the BEAD Feasibility Study, trusting the clinician and the information they provided about the study during labour was an important factor in their decision to participate. This was reported less commonly for those who declined. Women looked to the healthcare professionals providing their care during labour for support and guidance.

In the device (Fetal Pillow^®)

The Fetal Pillow^® has been available for 10 years and used at surgeon discretion at one of our recruitment sites (as well as globally). There was mixed understanding about the device with some survey respondents misunderstanding the device to be ‘new’ and therefore a deviation from standard care, while others agreed or wanted the device to be used despite no evidence for benefit.

Overwhelmed in the moment

Initial reaction

Some survey responders described an initial reaction of feeling overwhelmed at having the study introduced to them in labour. However, when the study was explained clearly by clinicians, many felt comfortable to participate.

More time

For a small number of survey responders who declined participation in the BEAD Feasibility Study, the already stressful situation of an unexpected event (caesarean section) meant that it was not the right time for them to discuss research.

Sub-analysis of Māori responses (equity focus)

There were 11 survey responders who self-identified as Māori, representing 8% of all survey participants. The small sample size limited thematic analysis with an equity lens. However, their responses revealed similar themes to non-Māori participants but with less positivity. This was mainly related to the theme of being overwhelmed in the moment, with Māori participants more likely to report that being approached for intrapartum consent was a suboptimal experience, for example, ‘it felt a bit rushed …’ (P140D), and that the information presented was ‘very confusing’ (P110D). Yet it was reassuring that the majority of Māori patients (8/11) who were approached and completed the survey consented to participate in the BEAD Feasibility Study.

Clinician interviews

Interviews were conducted with 12 doctors (6 consultants and 6 registrars, half from each recruitment site) and 6 hospital midwives (all from Middlemore Hospital). Clinicians could appreciate that ‘trying to get consent in an emergency is difficult… not impossible… but a challenging thing to do’ (MW1), however feasible ‘as long as people can understand what’s involved’ (MW2) (Table 5).

Table 5.

Clinician responses to questions around the BEAD Feasibility Study consent process.

Timing of consent
Theme 1 – Practical consent, not premature‘I know there are lots of strong opinions on this, but no, I don’t think there’s a better time. I think that consenting people for a study that they may not be eligible for doesn’t make any sense. So, I think that the time to consent them is when you’ve made the decision that you’re going to theatre to either do a trial or a Caesarean. [We may] potentially harm people by consenting them for something they’re not actually eligible for.’ (D2)
‘Look consent in labour is fraught … But the process you have at the moment is actually quite reasonable. It’s a difficult study to do, because we’re consenting patients in their second stage but I don’t see any other way of doing it as well.’ (D10)
‘I think the timing is really difficult, but I don’t think it’s appropriate to discuss it [earlier]. Because it’s not that common to have a Caesarean at fully dilated and what we want for women at that stage is to believe that that they will probably be able to have the baby vaginally.’ (MW6)Theme 2 – Early awareness, better prepared‘I think the BEAD study should be brought up at antenatal clinic for everybody, regardless. So that people can be aware, and then when we say BEAD study, then they go, “Oh, that’s right, there was something in the antenatal clinic about that, I remember,’ or “No, nobody told me anything about it.”’ (MW3)
Quality of intrapartum consent
Theme – Communication and context‘There’s definitely practitioners that are excellent communicators, and the information is more easily understood by women. And they have been in and out of the room, and they know the woman already. I think that’s helpful in getting consent.’ (MW6)
‘There can be issues about the quality of the consent. Because I think some women aren’t completely with it. A lot of them are exhausted and worried and tired.’ (MW2)
‘I think it’s as good as any other intrapartum consent that we’re getting honestly, maybe better, because there’s special attention being paid to it, because it is a study rather than just a practice that requires consent.’ (MW1)
Two-stage consent process
Theme – Empathetic and flexible‘I think a brief consent is really appropriate. And then following it up when they’re maybe more able to chat about it, I think, is considerate. I think that is a really good approach.’ (MW1)
‘It’s obviously discussed at the very time in which the woman’s quite vulnerable … But obviously the woman has the choice to opt out later on. Obviously, if they can initially go with it, and then, if she decides she doesn’t want to be a part of it later on, there is that choice.’ (MW4)
‘I think the way that we’re consenting in this study and talking to people after the fact about how they’ve provided consent is actually really relevant, not just to this study, but potentially to other future studies, and also to consent in general in an emergency situation.’ (D2)
Experience of approaching patients
Theme – Positive but pressured‘I felt very comfortable. I think that you’re already in a high stake’s situation. You’re consenting for a full dilation section. For me it hasn’t felt awkward to then say, also, we’re doing a study. And this is what the study is.’ (D2)
‘It’s how you frame it to the patient. I’ve kept it very simple with the counselling. The BEAD [study team] gave us verbal queues you can use to make the consenting of the study more easier. I haven’t found any issues.’ (D4)
‘I would say usually quite positive. Most patients consent to this. But on a busy delivery suite sometimes we don’t have time to fully explain to the patient. There are also patients that [are] not native English speakers. And it’s very hard to explain sometimes to say like this is a device that we’ve used all over New Zealand. We’re just testing to see. … It seems like sometimes patients fixate on the fact that like we’re testing something on them.’ (D11)
‘I try and make it a sort of routine intervention that’s offered to women to take part in the trial … And I find when women are sort of aware that this is already been in use for several years, and it’s something that’s done routinely anyway, they’re usually really happy to take part in the trial rather than phrasing it as a new unknown intervention.’ (D7)

D = doctor; MW = midwife.

Timing of consent

Themes – (1) practical consent, not premature and (2) early awareness, better prepared

The optimal time to consent patients for the BEAD Study was felt to be ‘tricky’ or ‘difficult’ by most who were interviewed. Many felt discussing the study with those who become eligible (at decision for CSFD) was ‘practical’ and the most pragmatic way to conduct the study but that the addition of antenatal information for patients may be helpful.

Quality of intrapartum consent

Theme – communication and context

Clinicians observed that the quality of intrapartum consent varied due to factors such as time constraints, patient condition and how clearly clinicians were able to communicate study information, which sometimes limited patient understanding. Despite these challenges, many felt the process was appropriate and that the research context often improved consent quality through greater attention and repetition.

Two-stage consent process

Theme – empathetic and flexible

Clinicians viewed the two-stage consent process positively, noting it enabled informed decision-making despite the challenges of labour. They felt the abbreviated intrapartum consent followed by full postpartum consent was a ‘good process’ that respected women’s autonomy and could serve as a model for future studies.

Experience of approaching patients

Theme – positive but pressured

Doctors report mixed experiences when approaching patients in labour about the study. Some reported feeling ‘very comfortable’ (DR2) and had ‘no issues’ (DR4) and made trial participation a ‘routine intervention’ (DR7). Others felt on a busy delivery unit they didn’t always have time to ‘fully explain to the patient’ (DR11) or faced other challenges such as language barriers.

Discussion

This study explored the acceptability of a two-stage consent process – abbreviated intrapartum consent followed by full postpartum consent – for an intrapartum randomised controlled trial (the BEAD Feasibility Study) investigating use of the Fetal Pillow^® during CSFD. The process was broadly acceptable to both patients and clinicians. Overall, 69% of those approached during labour consented to take part, and only two withdrew postpartum citing data privacy concerns. Recruitment exceeded feasibility targets, suggesting that this consent approach is practical in time-sensitive obstetric settings.

Clinicians predominantly used verbal explanations when introducing the study during labour, and most consenting patients felt this was sufficient. Patient experiences centred around three core themes: (1) benefits of participation, (2) trust in healthcare and (3) feeling overwhelmed in the moment. While the study context was generally well accepted, both clinicians and patients – especially patients who declined participation – highlighted the importance of more time to consider involvement. Clinicians also reflected that while intrapartum consent quality could be affected by clinical pressures, the two-stage model supported informed choice and may offer a respectful, flexible framework for future intrapartum research.

As recognised in other maternity studies and from our findings, improved antenatal awareness of a research study may help facilitate intrapartum consent discussions.^12–14,24We need to balance the availability of information for all who wish to engage, with the potential to overburden and create excessive anxiety about an event (CSFD) which is unlikely.¹⁵ Indeed, a recent study using verbal consent with written retrospective consent for a prospective cohort study around postpartum haemorrhage reported that patients were happy to be presented with pertinent information to decide about participation in research within an emergency setting, although only those who consented were included.¹⁴

Fewer than 3% of birthing women were eligible for the BEAD Feasibility Study and we cannot predict prior to advanced labour who these will be. There is no evidence to suggest harm to mother or baby from use of the Fetal Pillow^®, and therefore, we are continuing the two-stage consent process for the larger BEAD Study. Following our analysis of feedback from survey participants and clinicians, we will provide further education to community-based maternity providers about the study to share with pregnant people and are now evaluating providing study information at induction of labour. The abbreviated intrapartum consent has proven successful for recruitment in a time-limited (emergency) situation. The follow-up full postpartum consent provides a safety net, allows for more in-depth discussion and debrief, and an option for patients to withdraw their data from the study.

Strengths and limitations

A key strength of this study is the dual perspective of patients and clinicians. Importantly, we included patients who declined participation in the BEAD Feasibility Study when approached in labour. The rate (31%) of patients declining participation suggests that individuals felt able to make an autonomous decision, supporting the ethical integrity of the consent process. Their views and feedback are crucial for understanding and improving the patient experience and supporting recruitment. Survey participants were representative by ethnicity of those eligible for participation in the BEAD Study. The face-to-face approach provided a high response rate compared to other survey methods (e.g. email) and offered an opportunity for participants to discuss their experience of intrapartum consent and have their questions answered.

Limitations included fewer responses from those who declined participation in the BEAD Feasibility Study compared to those who consented. This is partly explained by an opportunistic approach to those who declined. The research team member who surveyed patients also requested postpartum consent which may have biased responses. In addition, it was not always possible or appropriate to complete the survey at the time the research staff visited due to patient factors which may have led to a less representative sample. This consent process has been designed and evaluated in a single study, and therefore, these findings may not be generalisable in all intrapartum settings.

Future research

Based on feedback from survey participants wanting earlier information, a further SWAT is planned.

Patients presenting for induction of labour at Auckland Hospital will receive a BEAD trial brochure. Regardless of mode of birth, they will be invited to complete a survey postpartum about how this information was received. This will help us assess the acceptability of providing trial information earlier, even to those ultimately ineligible for participation.

Conclusion

This mixed-methods study of patient and clinician experience of recruitment to an intrapartum study in an ‘emergency setting’ was largely supportive of abbreviated consent. Understanding the views of eligible patients on the consent process is crucial for optimising both patient experience and recruitment. We are continuing with our two-stage consent model including abbreviated intrapartum consent for the planned larger BEAD trial while trying to provide more information antepartum. This may be a useful consent model for other researchers to consider when undertaking peripartum trials involving recruitment in emergency situations and where opt-out or deferred consent is not available.

Supplemental Material

sj-docx-1-ctj-10.1177_17407745251412767 – Supplemental material for Exploring abbreviated intrapartum consent: A mixed-methods study of patient and clinician perspectives in the Baby head ElevAtion Device trial

Supplemental material, sj-docx-1-ctj-10.1177_17407745251412767 for Exploring abbreviated intrapartum consent: A mixed-methods study of patient and clinician perspectives in the Baby head ElevAtion Device trial by Jordon Wimsett, Charlotte Oyston, Robin Cronin, Erena Browne, Maria Boston, Lih Hwan Huang, Meghan G Hill and Lynn Sadler in Clinical Trials

Supplemental Material

sj-docx-2-ctj-10.1177_17407745251412767 – Supplemental material for Exploring abbreviated intrapartum consent: A mixed-methods study of patient and clinician perspectives in the Baby head ElevAtion Device trial

Supplemental material, sj-docx-2-ctj-10.1177_17407745251412767 for Exploring abbreviated intrapartum consent: A mixed-methods study of patient and clinician perspectives in the Baby head ElevAtion Device trial by Jordon Wimsett, Charlotte Oyston, Robin Cronin, Erena Browne, Maria Boston, Lih Hwan Huang, Meghan G Hill and Lynn Sadler in Clinical Trials

Footnotes

Acknowledgements

The authors would like to thank all the patients and clinicians who participated in the interviews.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.

Funding

The authors disclosed receipt of the following financial support for the research, authorship and/or publication of this article: Mercia Barnes Trust (MB 23-1 – Jordon Wimsett), HRC research delivery activation grant (HRC 23/735/A – Charlotte Oyston) and HRC Clinical Practitioner Research Fellowship (HRC 22/016 – Lynn Sadler).

Trial registration

ANZCTR. This mixed-methods research was undertaken as part of the BEAD Feasibility Study (trial registration number: ACTRN12623000758606; prospectively registered on 12 July 2023.

ORCID iDs

Jordon Wimsett

Robin Cronin

Lih Hwan Huang

Lynn Sadler

Supplemental material

Supplemental material for this article is available online.

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Exploring abbreviated intrapartum consent: A mixed-methods study of patient and clinician perspectives in the Baby head ElevAtion Device trial

Abstract

Background:

Methods:

Results:

Conclusion:

Keywords

Background/Aims

Methods

The research setting

Consent process for BEAD Feasibility Study

Stage 1: Abbreviated intrapartum consent

Stage 2: Postpartum full consent

Sample and recruitment

Patients

Clinicians

Data collection

Patients

Clinicians

Data analysis

Results

Benefits of participation

For self and/or baby

Altruism

Trust in healthcare

In clinicians

In the device (Fetal Pillow®)

Overwhelmed in the moment

Initial reaction

More time

Sub-analysis of Māori responses (equity focus)

Clinician interviews

Timing of consent

Themes – (1) practical consent, not premature and (2) early awareness, better prepared

Quality of intrapartum consent

Theme – communication and context

Two-stage consent process

Theme – empathetic and flexible

Experience of approaching patients

Theme – positive but pressured

Discussion

Strengths and limitations

Future research

Conclusion

Supplemental Material

sj-docx-1-ctj-10.1177_17407745251412767 – Supplemental material for Exploring abbreviated intrapartum consent: A mixed-methods study of patient and clinician perspectives in the Baby head ElevAtion Device trial

Supplemental Material

sj-docx-2-ctj-10.1177_17407745251412767 – Supplemental material for Exploring abbreviated intrapartum consent: A mixed-methods study of patient and clinician perspectives in the Baby head ElevAtion Device trial

Footnotes

Acknowledgements

Declaration of conflicting interests

Funding

Trial registration

ORCID iDs

Supplemental material

References

In the device (Fetal Pillow^®)