Australian midwives use tiny, unblinded study to claim quackery could save millions

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Ever notice that most midwifery “studies,” like those of chiropractic or homeopathy come to the same conclusion? It’s always something like this: “we studied ourselves and we are the cure for everything!”

The latest midwifery “study” from Australia is destined to be a classic of this type. According to the headline in The Age, Childbirth program reduces caesarean rate, could save health system $97 million a year:

[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]The study on which this cost analysis is based is tiny, unblinded and involves quackery.[/pullquote]

Lead author Dr Kate Levett, now at the University of Notre Dame Australia, has conducted a cost analysis follow-up study, published in BMJ Open, that found antenatal education could reduce the rates of medical interventions during childbirth and therefore save the healthcare system up to $97 million each year.

The team multiplied the average saving of $808 per woman with the number of women giving birth for the first time in Australia each year – 120,000…

There’s just one problem. The study on which this cost analysis is based is tiny, unblinded and involves quackery.

The original study, published in 2016, is Complementary therapies for labour and birth study: a randomised controlled trial of antenatal integrative medicine for pain management in labour.

Midwives mobilized quackery — acupressure, visualization, massage and yoga — and found it is the cure for everything!

There was a significant difference in epidural use between the 2 groups: study group (23.9%) standard care (68.7%; risk ratio (RR) 0.37 (95% CI 0.25 to 0.55), p≤0.001). The study group participants reported a reduced rate of augmentation (RR=0.54 (95% CI 0.38 to 0.77), p<0.0001); caesarean section (RR=0.52 (95% CI 0.31 to 0.87), p=0.017); length of second stage (mean difference=−0.32 (95% CI −0.64 to 0.002), p=0.05); any perineal trauma (0.88 (95% CI 0.78 to 0.98), p=0.02) and resuscitation of the newborn (RR=0.47 (95% CI 0.25 to 0.87), p≤0.015)…

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The results are nothing short of astounding! Epidural use dropped from 68.7% to 23.9%; unassisted vaginal birth rose from only 47% to 68.2%; the C-section rate dropped from 32.5% to 18.2%; Pitocin augmentation dropped from 57.8% to 28.4%.

How did these miracles occur? It was so simple any midwife could do it!

The tools used were:

Visualisation—four guided visualisations rehearsed through the courses and given to participants on a CD to practice at home;

Yoga postures—five postures and movements practiced to encourage relaxation, physiological position for labour, opening of the pelvis and downward descent of the baby;

Breathing techniques—four breathing techniques were introduced: soft sleep breaths for relaxation between contractions; blissful belly breaths (BBs) which were used during contractions for pain relief; Cleansing Calming Breaths used following contractions during the transition period of labour; and the gentle birthing breath (GB) which was for use during the second stage of labour and encouraged descent of the baby avoiding active pushing and protection of the pelvic floor;

Massage—two techniques were shown to partners: the endorphin massage used between contractions, which is a soft technique and encourages endorphin release; and the stronger massage which is used during contractions for pain relief and focuses on squeezing the buttock, especially the piriformis muscle, to interrupt pain perception;

Acupressure which uses six main points for use during labour selected from a previously published protocol. These focus on hormone release for labour progression, augmentation of contractions, pain relief, nausea and positioning of baby;

Facilitated partner support uses the concept of working with pain and instructs partners to advocate for the labouring woman, promoting her oxytocin levels and minimising her stress with actions and techniques which are supportive for the birthing woman, and gives time for facilitated discussion and rehearsal by couples during the course.

Usual care consisted of the hospital-based antenatal education course routinely available at each hospital…

Extraordinary claims require extraordinary evidence and this study is both tiny and unblinded.

It involved only 176 women. And although the authors claim that the study was blinded, blinding was impossible since the study group employed techniques that only they had learned. It was easy for midwives to determine which group received the specialized training and consciously or unconsciously treat them differently (for example, allowing the control group to receive epidurals while pressuring the study group to avoid them).

There were more problems than tiny sample size and unblinding.

A comment submitted in response to the paper noted:

The findings are contradicted by existing research on epidurals and C-section rates:

It seems to us that the study was designed to assess both pain control and unnecessary medical intervention. Epidural use as analgesia was used as a surrogate measure for failing pain management during labour. Whilst the use of surrogate endpoints can be highly problematic,the authors justify its use in this case due to its role in initiating the ‘cascade of interventions’. They describe that as epidural rates increase, so do the rates of instrumental births and other associated unnecessary medical interventions.

Whilst reviews cited by the authors have shown instrumental deliveries may increase, the same high-quality evidence shows epidural blocks neither increase the overall caesarean rate nor adverse neonatal outcomes…

Levett et al assume that epidural blocks are used when other pain management strategies fail. We question whether this is a true reflection of how epidurals are used in practice. Epidurals can be placed early in labour, which allows for the use of blocks with fewer side effects however delivery suite personnel and other factors occasionally delay administration. As such the rate of epidural block may more accurately represent women’s antenatal attitudes to pain relief during labour rather than the pain they experience. Previous studies have assessed attitudes towards analgesia and the birthing process as a baseline characteristic between groups.

The findings are contradicted by existing research showing that epidurals increase the rate of operative vaginal delivery:

Despite approximately three times the epidural rate in the control group there was no significant difference in the instrumental delivery rate. Epidural analgesia increases instrumental delivery rate by approximately 1.4 times. Given the differences in epidural rate between groups, the magnitude of this effect would be expected to be detectable with this sample.

Notably women in the study group felt they had significantly LESS control over the birth process suggesting that it was the midwives who determined whether the patients received pain relief and interventions, NOT the patients.

Finally, the findings are contradicted by multiple studies on complementary methods in childbirth that show that none of the methods employed relieve pain or reduce interventions.

So what are we to make of this study? Not much. It claims that quackery dramatically reduces epidural and C-section rates but the tiny sample size, unblinded nature of the study (and the fact that study participants felt they had less control over their births) and well as anomalous findings suggest that the study itself if meaningless.

Despite the ever-desperate desire of midwives to promote themselves and their nonsense, midwives are not the cure for everything.