Feasibility of a RCT of techniques for managing an impacted fetal head during emergency caesarean section: the MIDAS scoping study

Analysis

Jisc online surveys only collects and analyses full responses, and no completion checks were built-in; therefore, partially completed surveys were automatically removed from the final analysis. Prior to analysis, all data were de-identified by removing any e-mail addresses provided for contact regarding future studies.

Descriptive statistics of survey data were generated using Stata version 16 (StataCorp LP, College Station, TX, USA). Data were presented as n (% of total responses) and, where appropriate, the mean± 1SD, median [interquartile range (IQR)], and minimum and maximum data were reported.

Sample and recruitment

A systematic sample of women was recruited through one large teaching hospital in England. Women were eligible if they had experienced a second-stage CS in the 24 months prior to recruitment, were aged ≥ 16 years, had adequate spoken English and were able to give informed consent. There were no exclusion criteria. All women who were eligible over a 24-month period (n = 140) were identified from medical records. Of these, 80 were invited to participate: 50 who lived in deprived areas [i.e. an Index of Multiple Deprivation (IMD) decile of 1 or 2] and 30 who lived in less deprived areas (i.e. an IMD decile of 3–10). Women who were interested in taking part returned a response letter in a pre-paid envelope to the research team providing contact details and a signed consent form. Postal responses were returned by 19 women interested in taking part: 17 consented and two expressed interest but did not return the consent form. Of the women who consented, nine (53%) were available to be interviewed.

Women were offered an initial telephone call with a research psychologist so that they could ask questions and state their preference to take part in a one-to-one interview or a focus group. Nearly all women preferred one-to-one interviews. Interviews were conducted at the university campus by two practitioners: a psychologist experienced in qualitative research with vulnerable groups, and our parent and public involvement co-investigator, who has extensive experience in explaining birth-related information in an accessible way, via antenatal teaching. Women were able to bring their baby to the interview and were reimbursed for travel and childcare costs.

Before the interview, participants provided sociodemographic information and were given some brief information about the study and the different techniques used for IFH. During the presentation, participants were shown photographs and physical prototypes of the fetal pillow and Tydeman tube instruments. Using a topic guide, a 45-minute semistructured interview was then conducted to explore participants’ experiences and views on the acceptability of different techniques and a RCT of techniques. This interview guide was developed for this study and is provided as Report Supplementary Material 1. Not all women were aware of whether or not they had experienced an impacted head. Women were shown photographs and diagrams to illustrate the different techniques and, where appropriate, were shown a real-life version (fetal pillow and Tydeman Tube) that they could handle themselves. A model pelvis and baby were also used to explain the different techniques.

If women required additional information about their birth and/or referral to an obstetrician, they were encouraged to contact their general practitioner (GP). The participant information sheet provided recommendations of whom they could contact. The number of interviews conducted was dependent on the women’s availability. All interviews were audio-recorded and transcribed using an external transcription agency.

Data analysis

Audio recordings were transcribed verbatim and analysed using systematic thematic analysis. 8 A combined inductive and deductive approach was used with the following steps. First, all transcripts were read so that researchers could become familiar with the data. The transcripts were then re-read, and initial codes were identified and coded. When no further codes emerged (i.e. data saturation was reached), all of the codes were examined by two researchers (GR and SA), who agreed which were most frequent or could be combined into key themes. Themes were cross-checked against coded quotations to ensure reliability of coding and that main themes were represented. Analysis was conducted using NVivo 12 (QSR International, Warrington, UK). 9

Obstetricians, midwives and obstetric anaesthetists

Recall of previous incidences of IFH is reported in Table 1. The majority of health-care professionals had encountered IFH during emergency CS [n = 190 (92%) obstetricians; n = 30 (86%) midwives; n = 38 (100%) obstetric anaesthetists]. Among those with previous experience, obstetricians had observed a mean of 24.0 (range 2–300) cases, midwives had observed a mean of 6.1 (range 1–50) cases, and obstetric anaesthetists had observed a mean of 12.0 (range 1–70) cases.

Information on the current use of various techniques to manage IFH in health-care professionals is shown in Table 2. The vaginal push technique (84%) and operating table tilted down (80%) were most commonly used by obstetricians; 89% of obstetric anaesthetists had previously administered a tocolytic agent to the mother, and 69% of midwives had previously used the vaginal push technique.

All groups were asked to comment on their willingness to participate in a clinical trial and offer opinions on the acceptability of the various techniques for inclusion in a RCT aimed at managing IFH during an emergency CS (Table 3). For obstetricians, the most accepted techniques for inclusion in a clinical trial were, in order of preference, the insertion of fetal pillow [n = 178 (86%)], the vaginal push technique [n = 107 (52%)] and the ‘pull technique’ [n = 107 (52%)]. Among those who reported ‘other’, responses included ‘pushing the head up myself before starting the caesarean’; ‘using my non-dominant hand to deliver the head with the table tilted down’; ‘standing on a step’; and ‘patience and waiting for the uterus to relax with steady longitudinal traction’. Other responses included ‘using left hand to lift body up then inserting right hand below head’ and ‘rather than push the baby’s head up I request flexion of the head by a senior assistant i.e. not just blind pulling’. Information regarding obstetricians’ required training for the delivery of a clinical trial intended to manage IFH is presented in Table 3. The vaginal push technique was most accepted by midwives [n = 26 (74%)] and the administration of a tocolytic agent to the mother was most accepted by obstetric anaesthetists [n = 24 (63%)].

Parents

A total of 259 parents completed the parent survey: 256 (99%) had given birth in the previous 5 years and three (1%) had a partner who had given birth in that same timeframe. Most respondents (n = 113, 44%) were aged 30–34 years. Of the respondents, 196 (76%) reported one previous birth, 56 (22%) reported two previous births and seven (2.7%) reported three previous births.

Parents were presented with a scenario (Box 1) and asked to report their views on the acceptability of various techniques to deliver a baby with IFH during an emergency CS (Table 4).

Parents were also asked to report, using a Likert scale of 1 (least likely) to 5 (most likely), the likelihood that they would take part in a study during labour to determine the best techniques to deliver a baby with IFH. Ninety-eight (38%) respondents scored 3, 4 or 5, and 161 (62%) respondents scored 1 or 2. Participants who scored 1 or 2 were asked to report the reasons why they would be unlikely to take part in such a study. Of these respondents, 101 (63%) stated that they would prefer the doctor to deliver the baby in the way they felt most comfortable, 33 (20%) stated that they did not like the concept of randomisation and 27 (17%) would not like to have to think about a research study while in labour. Suggestions were made regarding a combined decision tool, specifically a combination of the doctor’s judgement and the computer-generated result, while also considering the success of such techniques from previous deliveries. One woman also stated that she felt she would not ‘make the best decisions whilst in pain and would prefer to be approached with comprehensive information before being in labour’.

Sample characteristics

Nine participants were included; all were 30–40 years of age and white British. Five participants were married, and the rest (n = 4) were living with their partner. The majority of women were educated to degree level (n = 5) or above (n = 1). All participants were in employment across a range of industries, including health care (n = 3), retail (n = 3), probation (n = 1), education (n = 1) and catering (n = 1).

Main themes

Three main themes were identified: (1) acceptability of different techniques; (2) informed choice in trials; and (3) birth education. Each theme had a number of subthemes, as shown in Table 5.

Round 1

Round 2

Round 3

Design

We undertook a qualitative interview study of health-care professionals’ and women’s views on the acceptability and feasibility of RCTs designed to determine the most effective technique for managing IFH at second-stage CS.

Ethics approval

Ethics approval was obtained from the West Midlands, Solihull, Research Ethics Committee (REC 19/WM/0118). The study was conducted in accordance with the ethical principles originating from the Declaration of Helsinki, 1996 (World Medical Association, 2013);20 and the Principles of Good Clinical Practice and the UK Department of Health and Social Care Policy Framework for Health and Social Care, 2017 (Health Authority Research, 2017). 21

Sample

Three samples of participants were identified for the purposes of this study: obstetric consultants or senior obstetric trainees, primiparous women, and women who had experienced an emergency CS in the 18 months preceding the interviews.

Procedure

Different trial designs

Two trial designs were proposed from previous work in the Management of the Impacted head At caesarean Section (MIDAS) programme. These are described in a visual guide in Report Supplementary Material 5. The first was a trial with two arms to compare the use of the vaginal push technique with the fetal pillow. Women would be randomised during emergency CS once it was established that the fetal head was impacted. The second trial design had three arms and randomisation was to occur prior to emergency CS at the point where IFH is anticipated. Women would be randomised to early disimpaction of the fetal head using the vaginal push technique, insertion of the fetal pillow or no action. The visual guide in Report Supplementary Material 5 was used during interviews with obstetricians and women to help them consider the different designs.

Data analysis

Audio-recordings were analysed using systematic thematic analysis. 8 A combined inductive and deductive approach was used. Data were analysed using the following steps. First, all transcripts were read so that the data became familiar. The transcripts were then re-read and all initial codes identified and coded. When no further codes emerged (i.e. data saturation), all the codes were examined by two researchers (Gabriella Romano and SA, or Georgina Constantinou and SA) who reached agreement on those that were most frequent or could be combined into main themes. Interviews for obstetricians and women were analysed separately and then compared to identify the main themes and subthemes from the different groups. The themes were relatively similar, so they are reported together. It is noted in the results section if themes or subthemes arose from only obstetricians or only women. Finally, the main themes were cross-checked against quotations to ensure that the quotations were reliably coded and represented the main themes. Analysis was facilitated by NVivo (QSR International, Warrington, UK), a specialist computer software package for qualitative analysis. 9 The approach used in this study was adopted from Ritchie and Lewis,22 who described the three inter-related stages involved, namely (1) data management, (2) descriptive accounts and (3) explanatory accounts.

Sample characteristics

Sample characteristics of women are given in Table 19. Women were all from white British, Scottish or European backgrounds. Two-thirds (69%) of women were educated to undergraduate or postgraduate degree level. The majority were married or living with their partner (88%) and in employment (94%). The average age was 32 years [standard deviation (SD) 4.9 years].

Sample characteristics of obstetricians are given in Table 20. The data show an even sex balance and that half of the sample were consultants. Mean years since qualifying were 18 (SD 7.2 years). Exposure to cases of IFH in the previous year ranged from 0 to 20 with a mean of 7 cases (SD 6.4 cases). Exposure to cases of IFH over the previous 5 years ranged from 0 to 150 with a mean of 41 cases (SD 44.2 cases).

Thematic analysis

Analysis of the interviews with obstetricians and women identified four main themes: (1) recruitment and consent; (2) feasibility and acceptability; (3) design considerations; and (4) outcomes. Each theme had a number of subthemes, which are shown in Table 21 and outlined in more detail below.

Theme 1: recruitment and consent

The first theme identifies a number of issues raised by obstetricians and women about barriers to and facilitators of recruiting women and health-care professionals into a trial. A number of ideas were shared on what to consider when engaging individuals in a trial. In relation to women’s recruitment, tackling the timing of consent was thought to be critical, and women and obstetricians frequently reflected on how best to present information to women to truly offer informed consent in an emergency situation:

It’s difficult because it’s already well known that taking consent for an emergency caesarean in itself isn’t full capacity consent-giving because women in that situation aren’t able to remember or retain what they’ve been told.

HCP08

I understand that you give the full clinical trial participant information 48 hours, erm, within a delivery but, you know, informed consent at that point it can be very difficult, especially if she hasn’t got an epidural.

HCP03

Obstetricians were mindful of the need to consult women to identify the optimal way to approach to consent and randomisation:

These are extremely sort of tumultuary circumstances that someone finds themself in when they’re delivering their baby and I think how you do that sort of consent procedure and randomisation would be, would have to be very carefully studied with PPI [public and patient involvement].

HCP07

Women also highlighted the barrier of trying to recruit under difficult circumstances when the woman is stressed and how this may influence the numbers of women willing to take part:

I think for most women in that situation, it’s going to be quite a fraught time, and um, and a stressful time, and I’m guessing it would be that moment that we would be introducing the . . . the . . . the study and the trial. Um, and I think that could cause undue stress to the mum, having to make a decision as to whether, oh, I need to be doing this, and I worry that that might mean that your um, er, numbers or women that were prepared to take part, would be quite low.

Primiparous W017

Information presentation was raised by women and obstetricians as important when recruiting and consenting women. This included consideration over when to present women with information about the trial, how much information to present, the content of the information and the format it should be presented in.

In terms of when to present women with information about the trial, views of obstetricians varied. Some thought women should be approached months before the birth and then, should an impacted head occur, at least women would already be aware of the trial when entering the labour ward. Others thought that information should be given on arrival at the labour ward:

I mean I think it would perhaps make more sense I think if all women in labour are actually given a leaflet about this so that they have time to think about it, just in case this were to happen to them. To give them more time to think about it. So any woman, I think, who is in labour and who is happy to take part in this trial, should be given this leaflet beforehand.

HCP06

However, most women stated that they would rather be told about the trial taking place earlier to allow them to process information before undergoing a CS:

Personally I feel like I would want to be approached before I went in theatre really ‘cos I feel like that’s, it’s such an intense thing. You know, if, if they think a caesarean or emergency caesarean is looming, I would want someone to approach me before everything starts going, you know. The chance to, the midwife to give it to me and give me chance to just read it in my own time so I can process it, ask some questions about it, but then to be reminded of it, you know, before, before it goes too crazy.

ECS W02

Women appreciated that IFH was rare but would like to be given information about the trial in their antenatal midwife appointments to minimise the impact of being asked to give assent when in labour:

I know obviously you say you don’t know until that point that it’s going to happen but whether it can be brought up in midwife appointments that there is, this trial ongoing and that obviously if this happens, this may come up, just so that when that does happen it, it’s maybe not a shock, it’s like, oh yes, I’ve read this about, I’ve read about this in, in the leaflet the midwife gave me, kind of thing.

ECS W09

Of those women who stated a preference to be given information early, some pinpointed the 20th to the 26th week of pregnancy as an ideal time to be approached about a trial taking place in the hospital:

I think the earlier the better, so maybe, at the point where they’re obviously, I wouldn’t say too early just in case there’s more complications with the pregnancy, or whatever, but maybe around the, the 26 week mark or, kind of when they know what’s happening more with the pregnancy, so they’re over that worry, you know, of actually being pregnant and what’s happening and getting that out the way and they’re used to that.

ECS W010

Being made aware earlier in pregnancy that a trial was taking place was also thought to improve the likelihood of women wanting to take part:

I think if I had the information about the trial before I gave birth, so then I’d be aware of it, that if an impacted head came up, oh this trial’s going to be discussed with me. I think if I knew about the trial before I went to give birth, then I would, I would be all for it, yeah, yeah.

ECS W013

In terms of how much information should be given, obstetricians argued this was very dependent on the context. They felt that when asking women to consent in emergency situations the information needs to be short and simple, whereas when providing information during pregnancy or after birth more detailed information can be given:

Because if you’ve done an instrumental, and you have been unsuccessful, you’ve got about three or four minutes, so at that point you’re going to say to them verbal, a verbal consent, but normally we would take a consent for a trial of instrumental in theatre. At that point, you should do the ‘do you want to join the trial, if this is unsuccessful?’

HCP02

Women had similar views, explaining that the language needs to be as simple as possible owing to the intensity of the situation:

Well it, it needs to be simple language, ‘cos you’re just kind of in a, in a space and in a zone where you’re not really understanding anything, and you, you’re that worried, because there is a complication and there is a problem.

ECS W013

When the time comes that the information is presented to you erm, in a really, in layman’s terms and make sure that I’m completely clued up about what’s going to happen.

Primiparous W018

Women stated that information given at the time of a CS should be kept to a minimum:

But I think definitely at the point of asking, the amount of information given should be the bare minimum if possible and if they want to know more and they’re in the right state of mind to ask more than they can.

ECS W009

In terms of the content of the information, obstetricians emphasised the importance of outlining the problem the trial is trying to solve:

In the . . . in the information, it would be really useful to have some, not necessarily figures, but some kind of idea as to the nature of the problem we’re trying to solve. So some kind of idea how frequent a problem occurs with a head that is difficult to deliver, either vaginally, or by a caesarean section. And that sometimes babies do have a lack of oxygen and we’re trying to improve on that. Something like that, but in laymen’s terms.

HCP02

Women thought that it would be useful to be given information about why the techniques had been chosen, including their effectiveness and safety as well as the potential impacts on both them and their baby. It was also deemed important to have a clear understanding of what will happen if a woman agrees to take part, particularly if the technique she is randomised to is not successful:

. . . be able to have some maybe facts or some science around why test this versus that and what is gonna happen to you and information on the safety of the baby and obviously if that technique doesn’t work how long is it tried for and then what happens, so just loads of information.

ECS W003

Women also would like to be reassured that either technique is appropriate and safe and that the obstetrician is well trained and confident in performing either technique:

I think I’d want to feel that being part of it. . . either option is great and the obstetrician would be equally as trained to do both, both of them are, well you can’t say both of them are as effective as the other ‘cos you’re trying to work that out aren’t you whether they are, which ones the most effective? So I think, I guess it would be a reassurance that both of them are good.

ECS W002

Obstetricians discussed providing information in different formats (i.e. verbal, written and visual) and that the trial should be explained as clearly and simply as possible:

I would feel that a written version should be shown as well, so apart from verbal like a laminated simple version, so it would have to be very simple, it couldn’t have all the complexities that many studies do have, it would.

HCP08

Women frequently discussed information being provided verbally and in written format and also the use of diagrams to help them understand the techniques. Women collectively felt that posters displayed in the clinics and waiting rooms were not as useful in providing information to women:

I think maybe considering, I think if I was in the waiting area and I saw it, I’d probably read it, but the fact that I’d never expect it to happen to me.

ECS W010

You said that the information was like available in antenatal clinics, but whether or not actually that’s enough, ‘cos I mean there’s loads of leaflets when you go to an antenatal clinic, you know, I mean I read them all because I get bored. But lots of women won’t, I think posters are quite passive.

Primiparous W001

It was thought that being actively given a leaflet to take away would be helpful, as opposed to having information available in waiting rooms, which they would probably not engage with:

. . . do you kind of make sure they have the information, when the lady’s come for their scans is that something that you could, is there a leaflet that you can give them when they come to the scan or. I don’t know whether that would be beneficial to you, you know, because I mean I see leaflets on the table and I’ll be very honest, I didn’t really pick any up because I got kind of leaflets and paperwork from my midwife appointments that I didn’t pick anything extra up when I was at the hospital.

ECS W012

Several women said that they preferred to receive information verbally from their midwife or clinician as a way to make them aware about the trial and also to reinforce information provided separately or at a different time. It was discussed that this reminder could be provided when arriving for labour:

I think it should be a clinician who’s involved in her care. So if she’s under consultant lead care, then it can be the consultant, if they’re under community midwife, then it can be the community midwife. And actually their part to play would be fairly small in . . . in that it’s just making them aware this study’s ongoing, here’s the information sheet.

Primiparous W017

So, if, you know, you do then go in, when you do go into labour and you know, the midwife who’s looking after you might say oh, have you, you know, did you read the information about the research trial that you were given at your scan? So, if they say yes, obviously you know there’s already some kind of understanding there and that kind of opens up the topic of conversation I suppose as to whether it is something they’d be happy to take part in if they needed to.

ECS W012

Barriers to and facilitators of recruiting health-care professionals and women were discussed by each group. Obstetricians reflected on how to engage other health-care professionals in a trial and recruitment in order to maximise participation. Advice included having a lead midwife for the trial to make sure midwives were engaged and recruiting during the day when consultants are present:

You need to make some kind of provision for somebody to be the lead midwife on the trial, not the lead obstetrician, the lead midwife, because if you don’t get midwives on board, it doesn’t happen.

HCP02

I think it would be feasible, I think recruitment would be better in daytime and when the consultants are around.

HCP03

Variation between sites was clear. Obstetricians working in sites with no access to the fetal pillow saw this as an attractive reason to take part in the trial, whereas obstetricians working at sites that were already using the fetal pillow saw this as less of an advantage:

I think it has to be really easy, has to be really er, clear, as to what is required. I think your er, possibly your jewel in the crown is that somebody is going to get the fetal pillow, so that’s attractive.

HCP02

In the last 5 years we’ve used the fetal pillow a lot more so the usual technique would be, well the current usual technique would be the fetal pillow.

HCP01

Obstetricians also emphasised the importance of the research team being accessible in case issues arise:

I think the most important thing is making sure that the research team are as accessible as possible for any issues which can happen. Making sure that the documentation is sent in a timely basis. Erm, obviously all the documentation needs to be as simply written as possible.

HCP06

Women reported factors that may influence recruitment to the trial. These included that introducing the trial early to primiparous women may cause them to worry about the birth of their baby or cause confusion:

I suppose there is a little concern now as to, would that make them worry because most women are not planning for a caesarean birth, and so if you start talking about caesarean birth at that point, will they get confused and think oh gosh, they’re going to force me into having a caesarean just for their study.

Primiparous WP17

In addition, it was discussed that knowledge of what to expect during birth may influence women’s willingness to take part, particularly first-time mothers, and that a woman birthing their second child may view the trial as more acceptable:

Maybe for not first-time parents because you’re only, you’ve already got no real idea, well I certainly don’t at the minute of what, what is going to go on. But if parents, if there’s a woman who’s had children before and has got a bit more experience in just the whole set-up of being, being in that situation and they have more of an understanding then may, then I’d think it’s more acceptable . . . but the preference would maybe to have women who are more, who have had children in the past, maybe.

Primiparous W018

Mm, I don’t know if it’s for my first child maybe not so much I’ve probably been through the situation and know for next time then you’re a bit more clued up aren’t you and probably a bit more relaxed about things.

Primiparous W018

Some women said that primiparous women may become aware of the possibility of a complicated birth through taking part in the study, and if they had not previously considered this then it may cause them to worry:

So, then you’re having that discussion about, you’re introducing the idea of a traumatic birth, you know quite far you know in the antenatal period. Yeah, I just it’s really difficult.

ECS W006

Women said that they may perceive being asked to take part in a trial as meaning there is something wrong with their baby and were worried this would cause panic:

I think if I was being asked, you know, are you happy to take part in this I’d be, like, what’s going on, like, is my baby still alive, like, it was such a panicked situation that I don’t know if that would make, that would kind of affect my decision making I guess.

ECS W002

Women also said that the word ‘trial’ could be perceived negatively as including ‘new’ or ‘poor’ techniques that might impact on safety. Therefore, the language used to present information about the trial was felt to be key to enhancing recruitment:

I feel like people, they hear the word ‘trial’, maybe they’d be a little scared and put off, just because you know, you view trials as something that’s not certain.

ECS W010

I think I’d just be a bit cautious of whether they would feel comfortable being used to test out these new techniques in case, you know, it didn’t work or something went wrong.

ECS W012

I think, as long as I had confidence that either technique was still potentially equally as successful as the other, you know, I wouldn’t want to think I was almost being a guinea pig for a technique which maybe was less um, less successful than the other one.

ECS W014