During the course of the study, challenges emerged in five sectors that are reflected as follows: 1) Selection of and support for cooperating hospitals; 2) Establishing a process of requesting informed consent; 3) Individual, digital real time randomization; 4) The standardized birthing room; 5) GCP-compliant documentation. In each following section, the relevant initial conditions in the participating hospitals will be outlined before the challenges are named and solution strategies are presented.
2.1 Selection of and support for cooperating hospitals
In Germany, midwives are authorized to conduct physiological births. They support and care for the birthing mothers independently in hospitals and cooperate with an obstetrician in pathological incidences. Midwives working in maternity hospitals generally have a high workload; nearly two-thirds of all midwives regularly look after three birthing mothers at the same time during one shift; in about a third of their shift they deal with unrelated additional work such as cleaning and are only seldom able to take a break; due to the poor working conditions, staff shortages prevail in many places since no applications for the vacant posts are made [25].
Challenges:
The challenge in the BE-UP study was to find hospitals where the rate of vaginal births was relatively low and thus potentially capable of improvement. Moreover, the staff there had to be sufficiently motivated to want to achieve this improvement. Since at least the BE-UP birthing room plus one other normal birthing room are required in order to carry out individual randomization, the hospitals must at the same time have an adequate number of birthing rooms available in comparison to the number of births. Furthermore, the layout of the normal birthing rooms (as the control group), in which many hospitals in Germany provide such things as pezziballs, ceiling ropes and birthing stools, should be clearly distinguishable from the BE-UP birthing room in order for the effect of the complex intervention to be examined properly.
Considering that the study can only be successfully implemented if the whole team has developed sufficient motivation to want changes in obstetrics to take place, it was important to find out whether an effective cooperation existed between midwives and physicians and whether they were interested in the study. This was difficult for the study team to recognize, especially if the head physician was very impressed by the study. In such cases, the midwives might feel patronized. In addition, thought had to be given to how personnel with little experience of clinical trials should be supported in conducting the study and their motivation strengthened during the study’s 36 months duration.
Solutions:
In many cases, the first contact was made via the head midwife. Apart from the number and size of the birthing rooms and the staff situation, we requested obstetrical data from the hospital’s perinatal report.
To inform the personnel about participating in the study, staff meetings were held during which the study team presented the study and responded to questions. After the cooperation contract had been signed, several introductory events were held in each hospital in order to save their time resources, despite considerable expenditure of time and money for the study itself. During the course of the study, staff meetings and further training sessions were also used to instruct new staff members. Since financial resources are limited in a publicly funded study, an expense allowance of 20 Euros per study participant was planned as an incentive for the hospital, which was intended to compensate for the expenditure of one additional hour required for informing the study participants and the documentation of the additional study data; however, this compensation had little effect because only seldom was the obstetric unit’s staff allowed to have it at their own disposal. We informed the staff about new announcements concerning the study, gave them helpful tips and tricks via email and the password protected study website. We also coordinated press announcements for the hospitals when the 100th or 250th baby was born within the BE-UP trial, all with the intention of providing continuous support and motivation to recruit women for the study.
During the course of the study, the study team organized several one-day study meetings for representatives of the staff in all of the BE-UP hospitals to facilitate interaction between them and to promote a sense of community and identification with the study. To raise the participation preparedness, travel and meal expenses for two people of each hospital were reimbursed from the study’s budget. The study team also presented interesting reports in regular newsletters for the hospitals’ obstetrical teams (e. g. managing a shoulder dystocia in upright maternal posture). Moreover, the participating hospitals were informed every month via email about the current recruitment situation.
2.2 Establishing a process of requesting informed consent
In Germany, pregnant women are free to choose whichever hospital they prefer for birth, but in most gynaecological practices the women are advised to sign up in a hospital in the close vicinity. Information about the hospitals and the care they provide can be obtained from the respective website or at information events. Expectant parents often visit antenatal classes held by freelance midwives or attend parenting classes in a hospital. Since most of the pregnant women are registered for giving birth in a hospital where a patient’s record is also set up, fundamental data about the women are already available when they arrive for the actual birth. Then they can be informed about the BE-UP study and taken to the birthing room in good time. In contrast, there is not always sufficient time to refer to the BE-UP study during the medical-diagnostic activities in special obstetrical risk consultations.
Challenges:
In the busy everyday hospital routine, the challenge for the BE-UP study centres is to draw the attention of all potential study participants – i. e. all pregnant women with a singleton pregnancy - at an early stage to the possibility of participating in the BE-UP study. Only then would the women have enough time to give their informed consent in writing. The Corona pandemic has complicated matters because the normal information meetings and antenatal classes were cancelled for weeks and pregnant women could register for birth only over the phone.
Solutions:
Comprehensive information for potential study participants was prepared and presented on the study website. There, the study centres were listed and explanatory materials approved by the ethics committee, i. e. information about study participation and informed consent for pregnant women, were made available for download (www.be-up-studie.de). All the text and image material was compiled with help and participation of user representatives. With the aim of relieving the hospital staff and supporting recruitment a multiple strategy was realized, consisting of printed materials (QR code, information card, flyers, website), each with increasingly more detail. When it was seen that recruitment was rather slow, the study team sent out QR code information cards and flyers to the gynaecological practices and midwives in the vicinity of the hospital, asking them to pass the information on to their pregnant patients.
In order to help pregnant women understand the information about the BE-UP study more easily, the study team commissioned two short films, one explaining the scientific target of the BE-UP study and one showing the process of participating in the study from the perspective of the women. The films were presented on the hospitals’ websites, on the study website, and in some cases also in the obstetric units’ waiting-rooms. To help the maternity staff to respond to occurring difficulties, some practical assistance was developed: a laminated page with the inclusion and exclusion criteria, a short text for focused consultations with the pregnant women who had not heard about the study when they arrived for the actual birth, and BE-UP stickers with the study website’s URL, which could be stuck in the pregnancy record book (Mutterpass) to remind an interested woman of the study, or else in their hospital record to indicate that she intends to participate in the BE-UP trial.
From the start of the study, the team was in close contact with the hospital IT departments until their websites had been set up satisfactorily with information about the BE-UP trial. During the course of the study, the IT departments added links on the hospital website to reach the study website, particularly the short films and special information about the situation in the Corona pandemic. The study team’s advice that being a BE-UP hospital would have a positive impact on its public relations image was warmly received not only at the beginning of the study. When certain milestones were achieved, for instance the hundredth birth within the BE-UP study, the press announcements for the hospitals were adjusted appropriately, uploaded to the hospitalꞌs websites and also sent to the editors of local newspapers.
2.3 Individual, digital real time randomization
When a pregnant woman arrives in the hospital to give birth, the first examination usually takes place in the admission room. Normally, she is then taken to a birthing room which she cannot select herself.
In the case of study participation, the inclusion and exclusion criteria are additionally checked, any remaining queries from the potential study participant are clarified, the completeness of the written informed consent is checked, and the midwife or physician confirms with his/her signature that the woman has been adequately informed. Then a digital real-time randomization is conducted – a proven procedure provided by the University’s Coordination Centre for Clinical Trials that also handles the data management of the BE-UP study. When the allocation to either the intervention group or the control group has taken place, the woman is taken to the corresponding birthing room.
Challenges:
The individual randomization in the BE-UP study does not refer to a single intervention but to an entire space, i.e. birthing environment (complex intervention), and is subject to special requirements: first, both the BE-UP birthing room and another normal birthing room must be vacant so that the random allocation to the intervention or control group can take place. Second, when taking part in the study, the women cannot choose a room, even if two rooms are vacant at the same time. For ethical reasons this might be perceived as being problematic because in recent years the self-determination of a birthing woman during the actual birth has been increasingly recognized and furthered.
Since there is a limit to the number of available birthing rooms (frequently all the rooms are occupied in the everyday life in a clinic), the staff has to undertake an effective room management. This means that the BE-UP birthing room has to be cleaned as quickly as possible so that it is available for randomization. Moreover, for a participant to be included in the study, as many of the midwives as possible should be instructed about the study so that the study implementation can take place with the specified accuracy and fidelity, and the data collection requirements are also fully met in cases where a colleague has to take over when shifts change. Lastly, during the recruitment period, randomization problems due to the absence of an online connection or to operational deficiencies of the randomization software needed a precautionary solution.
Solutions:
We recommended the midwives to arrange for the BE-UP birthing room to be the last one occupied and to use it primarily only for the study so that as many randomizations as possible can be made. In order to ensure this despite a large number of part-time employees, designated contact persons for BE-UP took on the task of specifically checking at shift begin whether a woman could be included at that particular time.
To increase the willingness of pregnant women to take part in the study, the study team asked the staff to emphasize that nobody knew which room was better for the woman and that she had a 50% chance of giving birth in the BE-UP room. It is, however, essential that the women are informed that they can assert their wishes regarding upright body posture and mobility in each birthing room and that the predefined quality standards for care in the hospital will be adhered to, signifying that disadvantages are not to be expected due to randomization.
At the beginning of the study, each of the hospitals were given an iPad for carrying out the randomization. In the course of the study, it was found that there were often less inhibitions and difficulties if their own online devices, such as smartphones or one of the obstetric unit’s computers, were used. Six sealed opaque emergency randomization envelopes were additionally provided so that the staff had an alternative, should problems occur during online-randomization; in this way, no potential study participants would be lost.
2.4 The standardized birthing room
Generally, birthing rooms in German maternity hospitals have a “technological” setup [42]. In the centre of the room is an electrically adjustable birth bed, there is a surgical lamp, an emergency anaesthetic unit, a paediatric care unit with a heat lamp as well as a sink and cupboards for storing material. Quite often there is a pezziball, a rope hanging from the ceiling and/or a birthing stool. The lights can be centrally dimmed and, if requested, the staff can provide drinks or snacks.
Challenges:
While the study was being conducted one of the birthing rooms in each hospital was set up as a BE-UP birthing room. An integral part of the BE-UP-concept is that the birth bed is concealed by a paravent, or is absent, thus creating a large contrast to the normal birthing rooms. The elements in the BE-UP birthing room (complex intervention) were designed in cooperation with midwives and patient representatives to conform optimally to the needs of a birthing mother requiring upright posture and mobility, distraction, relaxation and self-determination. In doing so, it must be ensured that the new setup fulfils the hygiene standards and that the staff can work in the BE-UP birthing room according to the hospitalꞌs own standards. The hospitals had to cover only a small share of the costs for equipping the BE-UP birthing room; the larger share was financed by the research’s sponsor. Particularly challenging aspects of equipping the rooms as BE-UP birthing rooms in the hospitals were: the limited size of the rooms (very little space for a mattress, floor mat, table and chairs), the built-in power and functional cables for the birth bed, frequently insufficient room for the birth bed outside the birthing room, the restricted manageability of the heavy floor mattress, the possibility of the foam elements slipping on the floor mat, the cool surface of the mattress and midwives’ complaints about backache.
Solutions:
To encourage the acceptance of the changes being made when setting up the BE-UP birthing rooms in the cooperating hospitals, we adopted a strong collaborative approach: the hospital staff were able to select the colours for the floor mat, mattress, foam elements, beanbag and chairs in order to achieve a good match with the existing colour concept in the birthing room. To accommodate the cramped space, we also offered a smaller table.
From the start of the study, the study team endeavoured to effectively support the hospital staff: for the new work with upright birthing postures, the hospital was given excerpts from the e-book “The physiological birth” on the iPad as well as the new edition as a printed copy. To stop the foam elements from slipping, the team provided anti-slip material for once-only use and to make the mattress surface more pleasant special terry-cloth sheets were provided. When the midwives in the BE-UP room complained about backache, during one of the study meetings special training in back-saving midwifery work was offered. And to offer teams greater confidence in handling a shoulder dystocia with the birthing woman in an upright position, we had a recognized expert develop a handout, a laminated copy of which is available in the BE-UP room.
2.5. GCP-compliant documentation
Many hospital midwives are very discontented with their jobs; the reasons are manifold – no breaks, habitual overtime and standing in for others as well as unrelated additional work [25, 43]. Above all, the high amount of documentation, which accounts for about 10 percent of the daily workload, is a particular strain on day-to-day working life; the midwives are frequently only able to do the necessary documentation when their shift is over [25] and this has increased in recent years [43].
Challenges:
In a clinical trial the documentation of data should correspond to the guidelines of “good clinical practice” (GCP) and the respective demands are high; in obstetrical hospitals in Germany, documentation is normally digital but various types of documentation and administration software are in use. This means it was impossible to get a homogeneous digital documentation of routine data for use in the trial; at the same time, responsibility for documentation software rests with software providers based on legal contracts, and access to documentation software is linked to hospital-specific routines.
Solutions:
Since the study team did not want to burden the hospital staff with additional unfamiliar documentation software, the case report forms (CRF) comprising routine obstetrical data as well as additional trial-related items were prepared in printed form.
Simultaneously, the study team explored the possibility and willingness of the software providers to supplement the existing hospital software with a “module” for the BE-UP study in order to avoid double documentation and to keep the time required for the trial’s documentation as low as possible.
Upon request and within the frame of their service contract, the developers of the software systems GeDoWin®, Viewpoint® and Nexus® prepared a solution for the automatic transfer of routine data into a digital BE-UP case report form. Thus, about 50% of the approximately 100 items could be incorporated in the CRFs at the push of a button. In eight of the 17 participating hospitals there were either system-specific IT hurdles or work organizational, hospital-specific hurdles, or else the team opted for handwritten documentation.
Multi-stage monitoring was implemented to check on the data quality: monitoring visits every four weeks served to check the ongoing recruitment process and to inspect and validify the data in the CRFs before sending them to the Coordination Centre for Clinical Trials. The Lead Monitoring Officers, who are always easily reached by telephone, visit the hospitals every two months to check whether the complex intervention is being implemented according to the study protocol, whether recruitment is running as planned, and to deal with any special cases or challenges. Finally, they handled any enquires resulting from the plausibility checks of the Coordination Centre for Clinical Trials that it undertook in the course of its query management.