The TUFF-trial
Antenatal Preparation for Childbirth and Parenthood
Effects of two models of antenatal education on epidural rates and experience of childbirth and early parenthood:
a randomised controlled trial.
Malin Bergström,
Helle Kieler,
Ulla Waldenström,
Design and process of the TUFF trial
Background
In most high income countries expectant parents are invited to childbirth and parenthood education during pregnancy. Such education is however poorly evaluated. A systematic review in the Cochrane Library included six randomized controlled trials, which evaluated the effect of antenatal education given as group sessions or individually on knowledge acquisition, mode of delivery, experience of childbirth, breastfeeding and parenthood [1]. A total of 22 studies were excluded due to methodological problems. Of the included studies only one was considered being of high quality [2]. The systematic review concluded that the effect of general antenatal education remains unknown.
Besides the randomised controlled trials, a number of observational studies of antenatal education have been published. However, conclusions about effects are difficult to draw from these studies. Although antenatal education in many countries reaches a large majority of the pregnant population several studies have shown that young, single and socioeconomically disadvantaged groups are underrepresented[3-10].
Antenatal education in Sweden
In 1978 antenatal education was introduced as part of routine antenatal care in Sweden, most of which is organized within the public sector[11]. The focus then shifted from childbirth preparation including physical exercise and relaxation to a stronger emphasis on information and discussions in groups of both expectant mothers and fathers. Recommended topics were about pregnancy, childbirth, breastfeeding and the upcoming parenthood. The goals were 1) to increase knowledge, 2) to stimulate contacts between expectant parents and 3) to increase awareness of social conditions in order to facilitate active involvement in the society. The groups were led by a midwife at the antenatal clinic and the number of recommended sessions was eight to ten [11]. Both nulliparous and multiparous women and their partners were invited to attend the classes.
The structure and content of antenatal education has changed over the years. Today mainly nulliparous women and their partners are invited and the number of sessions has decreased to a mean of four. Parenthood preparation and the relationship between the couple has become an even more important component. Childbirth preparation by means of practical training in breathing and relaxation techniques is less common than during the 70ties and 80ties. Current antenatal education in Sweden may also differ between antenatal clinics, and even between individual group leaders.In many parts of the country private entrepreneurs offer classes in yoga or psychoprophylaxis as childbirth preparation. However, most antenatal education is still organized by the antenatal clinics within the public sector. Approximately ten percent of the antenatal midwives’ workload is allocated to antenatal education. The total cost for parental education was in 2004 estimated to 2000 SEK per child[12].
In 1997 the importance of evaluating current childbirth and parenthood education in Sweden was stressed since no evaluation had not been done since the introduction of the reform [13]. In 2004 the National Institute of Public Health released a report which concluded that more research is needed, in particular randomised controlled trials[12].
Current research in Sweden
The Swedish KUB study (Women’s Experiences of Childbirth), which is an observational study of around 3000 pregnant women recruited from 97 percent of Sweden’s 600 antenatal clinics during three weeks evenly spread over one year (1999-2000) ( reported that 74 percent of the first-time mothers found antenatal education helpful as preparation for childbirth and 40 percent as preparation for parenthood, when asked two months after birth [14]. One year after the birth, 58 percent of the women still met with other class participants. When controlling for the selection of women into participants and non-participants, no statistical differences were found concerning memory of labour pain, mode of delivery, overall birth experience, duration of breastfeeding or assessment of parental skills. However, participants had a higher rate of epidural analgesia[14].
Another finding was that only 14 percent of the women used psychoprophylaxis during labour[15]. Two months after delivery the efficiency of different methods for pain relief was rated by the women. Epidural analgesia was assessed as the most effective method for pharmacological pain relief and psychoprophylaxis as the most effective non-pharmacological method. Psychoprophylaxis was rated as more effective than acupuncture, TENS, sterile water papules, shower/bath, and approximately as effective as entonox and pethidine [15]. Apart from the positive finding that antenatal education in Sweden seems to promote contact between new parents the study failed to show any positive association between attendance in antenatal classes and mode of delivery, or the experience of childbirth and or parenthood[14].
In general, the attitude of the staff at the antenatal clinics is very positive to antenatal education. Most midwives see it is an essential part of antenatal care, which strengthens the psychosocial perspective on pregnancy, childbirth and early parenthood in the clinical practice [16].
Although the need for evaluations of antenatal education is frequently stressed, it is impossible to conduct a trial where half of the participants are randomised to a control condition with no education since antenatal education has been part of routine care for so long and its efficiency is, within clinical practice, generally taken for granted. This is probably one of the reasons why randomised controlled trials are scarce. We have therefore chosen to conduct a trial comparing two different models of antenatal education.
Methods /design
This study is a two arm, unblinded randomised controlled trial, which comparesone antenatal education model focusing on natural childbirth with psychoprophylaxis, with another model representing standard antenatal education in Sweden.
Aim
The aim of the study is to determine whether antenatal education focussing on natural childbirth preparation and psychoprophylaxis (Natural group) will improve first-time mothers’ and fathers’ experience of childbirth, decrease the use of epidural analgesia and/or affect experience of early parenthood, compared with a control group offered the standard form of antenatal education (Standard care group).
Outcome variables
The primary outcomes are: epidural analgesia during labour, experience of childbirth and parental stress in early parenthood.Experience of childbirth is measured with W-deq B, the Wijma Delivery Experience Questionnaire, [17]and experience of stress in parenthoodwith SPSQ, the Swedish Parental Stress Questionnaire[18-21], in men and womenthree months after delivery.Secondary outcome is parental satisfaction with the antenatal education program.
Hypotheses in relation to primary outcomes
- Less women in the Natural group will use epidural analgesia during labour.
- Women in the Natural group will rate labour as less painful at three months after birth.
- Women and men in the Natural group will have a more positive overall experience of childbirth.
- Women and men in the Standard care group will experience less stress in early parenthood.
Hypotheses in relation to secondary outcomes
- Overall satisfaction with the antenatal education program will not differ between the Natural and Standard care groups
- Satisfaction with antenatal education as preparation for childbirth will be higher in the Natural group
- Satisfaction with antenatal education as preparation for parenthood will be higher in the Standard care group.
Study population
Pregnant women who attend the antenatal clinics involved in the trial will be invited to participate in the trial if they are: Swedish-speaking, nulliparous, and assessed by the antenatal care midwife as able to benefit from group antenatal education. The women’s partners will also be invited, without any exclusion criterias. Invitation will take place approximately in gestational week 21.
Sample size
Expected outcomes in the Standard care group are based on national statistics [22] and results from the KUB study [23-26]. The sample size is calculated in order to detect a reduction in epidural rates from expected 50% in the Standard care group to 40% in the Natural group,with 80% power at 5% significance level (two tailed). According to this 388 women are required per group.A slightly smaller sample is estimated to detect statistical differences in the other two primary outcomes (Table 1)
Table 1. Power calculation (95% CI, 80% power, 2-sided)Expected value
Group Standard / Expected value
Group
Natural / Number per
group
n / Total
Number / Number to be recruited
(20% loss)
Epidural analgesia, % / 50.0 / 40.0 / 388 / 776 / 970
Memory of labour pain, %: worst imaginable pain, Score 7
(Rating scale 1-7) / 28.0 / 19.4 / 383 / 766
Negative experience of childbirth, %
Very negative + negative, Score 4+5 (5-point rating scale: very positive-very negative) / 40.0 / 30.0 / 356 / 712
SPSQ – Parental stress, mean (sd): / m (sd) / m (sd)
Incompetence / 2.2 (0.7) / 2.2 +/- 0.25 / 372 / 744
Role restriction / 3.5 (0.8) / 3.5 +/- 0.30 / 338 / 676
Social isolation / 2.1 (0.7) / 2.1 +/- 0.25 / 372 / 744
Relationship to partner / 2.4 (0.8) / 2.4 +/- 0.30 / 338 / 676
Values in the Standard care group are collected from the KUB-study, which includes a representative sample of Swedish-speaking nulliparous women surveyed two months after delivery in 1999 and 2000.
Since randomization is made by groups and intra-group climate and communication may affect the outcomes, the power calculation has also been adjusted according to possible intra-class effects. Each randomized group of 12 persons (see randomization below) is considered a cluster which means that sample size must be increased to allow for adjustment of possible cluster effects in the analyses. The intra-class correlation coefficient is estimated to 0.02 [27, 28], variation in cluster size between midwives is estimated to range from 0 to 5, giving an inflation factor of 1.125. Thus the required sample size is estimated to 916, i.e. 458 women in each arm of the trial.
Assessment of eligibility
The antenatal care midwives on the participating clinics decide whether to invite the woman, or the couple, to participate in the trial. The inclusion criteria are the same as the general criteria for inviting women and men to antenatal education groups; Swedish-speaking and assessed by the midwife as able to benefit from group sessions. If a women if considered as too fearful of childbirth,to have severe problems with social interaction or special physical or psychological requirements, she will instead be offered individual antenatal education.
Recruitment and consent
The eligible pregnant woman and her partner, or single woman, are informed about the study by their antenatal midwife on their second visit to the clinic, approximately in gestation week 21. Written information about the trial is handed out as well as the baseline questionnaires, one to the woman and one to the man. The questionnaires include questions about sociodemographic background and expectations on antenatal education, childbirth and parenthood.
Women and men who decide to participate in the trial send the completed baseline questionnaires to the research group, which then is the formal expression of consent. The research assistant then notifies that the questionnaire has been received on the study specific homepage (see below). When the midwife is about to randomize a group she finds the verifications. Since a completed baseline questionnaire is a prerequisite for randomisation this procedure secures that baseline data is obtained before.
Recruitment of midwives
Approximately forty antenatal care midwives will be recruited for the trial, through advertisementin the Swedish Journal of Midwifery and information at a national meeting for antenatal care coordinators. Participating midwives will be randomised to hold education classes either according the Natural or the Standard care model during the entire study period.
Inclusion criteria for midwives
The following criteria are set up for the group leaders: currently working as antenatal care midwife; previous experience as group leader in antenatal education; a minimum of four antenatal education groups held in 2004; ability to lead at least four educational groups during the study period; willingness to be randomised to hold classes according to either model during the whole study period. At least two midwives per clinic are required for participation in order to enable classes according to both models at each clinic. Employers must be willing to cover the expenses for traveling and housing during the workshops of the trial.
Education of the group leaders
The midwives will be randomised to respective model before attending the first workshop, preparing for the trial. During this first workshop, prior to the onset of the trial, all midwives will be informed about the study and the requirements on their part during the study period. The group leaders in the Natural group will stay for an additional two-day workshop to get accustomed to the specific manual for this model. Two experts in psychoprophylactic training will lead the workshop which will include practical training in psychoprophylaxis. All the midwives will be encouraged to lead pilot groups according to the protocols before onset of the trial. The external experts in psychoprophylaxis will supervise the group leaders in the Natural group during the trial and will be accessible on telephone.
Two one-day follow-up workshops for all participating midwives will be organized during the course of the trial. Expenses for traveling and housing will be paid by the employers. If supervision of the group leaders in the Natural group is requested, this can take place during these workshops.
Randomisation procedure
The randomisation procedure is internet-based. A study specific randomisation algorithm has been created by MedscinetAB (see below). The algorithm is reached through a study specific homepage, where all midwives and study participants are being registered. The homepage can be reached by both the researchteam and the midwives in the clinics. Each participating clinic will have their own specific password. The homepage will also be used by the research team as an information channel to the midwives. Information about number of groups held, number of recruited participants etc will be displayed graphically. The research team has access to all information on the website.
Randomisation will be performed groupwise, in groups of six couples (or twelve single women) and stratified by clinics to ensure a relatively even distribution of the two models at each clinic. Randomisation will be performed by the midwives and date of expected birth will be the main grouping variable.
In larger clinics, Natural and Standard care groups may be held simultaneously. In such clinics, non-participants in the trial will be referred to antenatal educational groups outside of the trial. In smaller clinics, where only one education group is held at a time, non-participants will be included in the education group available even if this group is included in the trial. In these clinics all patients who want to participate in antenatal education will be randomised to either model, whether study participants or not. Since both models of education in the trial are designed according to the general aims of antenatal education in Sweden, this should be a plausible solution. The only difference between study participants and non-participants in these groups is that the study participants fill in the questionnaires.
The randomisation algorithm
The randomisation algorithm is based on analysis of variance for unlimited treatment groups with unlimited number of stratifying factors. The TUFF-study patients are randomised to two groups Standard and Natural; with one stratifying factor – balance of treatment groups within center. Thus, the following priority is always maintained: 1) Number of patients per treatment group must be kept as equal as possible; 2) Assignment of patients is performed in small groups of patients 8 to 12, because course is run group wise; 3) Thereafter, algorithm tries to keep approximately equal number of groups within clinic, but because this is second priority, the first priority always wins.
Data collection
Data is collected with questionnaires to both women and men. The baseline questionnaire, handed out by the antenatal care midwife, is completed at home and posted to the research team. Three months after the expected birth a postcard asking the parents to answer the follow-up questionnaire on a study specific homepage will be sent. After one week, if the parents have not completed the questions on the internet, a letter of reminder will be sent including paper versions of the questionnaires and a prepaid envelope. After another two weeks a postcard will be sent as a reminder and after yet two more weeks a telephone call will be made. When the follow-up questionnaire is completed participation in the study is finished. Women and men are free to withdraw from the study at any time. Information about this possibility will be included in all letters and postcards. No further study follow-up will occur if they choose to discontinue participation.
Baseline questionnaire
The baseline questionnaire contains questions about age, civil status, education, occupation, income, residency, ethnicity, partner relationship, worry and expectations on antenataleducation, childbirth (including expected use of methods for pain relief) and early parenthood.
Validated instruments in the baseline questionnaire
Expectations on childbirth areinvestigated bythe Wijma Delivery Expectancy Questionnaire, W-deq A, which contains 33 and 25 questions topregnant women and their partners respectively about feelings for the upcoming birth [17].Responses are given on 6-point Likert scales. Satisfaction with the relationship is measured by Barnett’s scale[29], which includes 15 statements (same for men and women), with responses given on 5-point Likert scales. Worry during pregnancy is measured bythe Cambridge Worry Scale[30, 31], which contains 16 items for women and 14 for men, and responses are given on 6-point scales ranging from 0 (=No worry at all) to 5 (Very strong worry).
The follow-up questionnaire
The follow-up questionnaires, whichwill be available both in web and paper format, includes questions about labour outcomes (mode of delivery, methods used for pain relief, augmentation of labour etc), satisfaction with theantenatal education (number of sessions, assessment of the group leader, content etc), socialization with other new parents, breastfeeding and emotional and physical wellbeing. Many of the single item questions are identical with those in “the KUB-study” to enable comparisons with a national sample of Swedish-speaking women who expect or have recently given birth to a baby. The questions about antenatal education are mainly created specifically for this study.