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Analysis

Birth technology device: an appraisal

4 June, 2008

Birth technology device: an appraisal

A new tool that may enable women to simulate giving birth has recently become available in the UK. Marlene Sinclair and Ian Bradbury investigated the evidence to see if the product lives up to the claims of the manufacturer.

 

A new tool that may enable women to simulate giving birth has recently become available in the UK. Marlene Sinclair and Ian Bradbury investigated the evidence to see if the product lives up to the claims of the manufacturer.

Midwives magazine: January 2006

 

Introduction

The purpose of this paper is to explore the effectiveness and efficacy of a new ‘natural birth technology’ device called EPI-NO and describe its use so that midwives, obstetricians and women will have the necessary evidence to make a judgement on its place in the birthing process.

 

Purpose and use of EPI-NO

 The EPI-NO birth trainer was designed and manufactured in Germany by Tecsana in 1999. It claims to train women to give birth vaginally using a simulation process similar to that used by African women, who insert gourds of different sizes into their vagina to train for birth (Tecsana, 2005).

Women using the EPI-NO start training for birth after 36-weeks’ gestation by inserting the device into their vagina, inflating it to a comfortable level and retaining the pressure for ten minutes before actively pushing the apparatus out of their vagina, thus ‘simulating the birth experience’.

 

Product description and purchase

The device is an inflatable silicon rubber balloon in the shape of a figure of eight and is connected via a tube to a manometer that acts as a pump to inflate the balloon and as a pressure gauge. EPI-NO has US Food and Drug Administration approval as a medical device,Health Canada approval with a medical device licence, and a CE mark that signifies its conformity to a European standard. These markers relate to product safety not effectiveness (Medicines and Healthcare Products Regulatory Agency, 2005).

 

We contacted the sole UK distributor to explore the purchasing process in this country. Tecsana appointed this woman in July 2005 – she had been working as a fitness instructor for five years and had completed one year of her midwifery education prior to her appointment. All product distribution in the UK and Ireland was arranged by personal contact between her and the buyer. She had strict control on how the product reached the buyer and conducted a telephone interview with each woman before releasing the product: ‘Every individual requesting the product is spoken to by me, to ensure any queries they have are answered before they part with any money. An order form is processed, which includes asking if there are any medical conditions and how advanced the pregnancy has progressed – this ensures no one buys the product with any contraindications and they are advanced enough into the pregnancy (34 weeks minimum) to be relevant for EPI-NO to reach them by 36- to 37-weeks’ gestation.’

 

Feedback

 All women who purchased EPI-NO were asked to complete a self-report questionnaire that sought information on their experience of using the product as well as details on parity, gestation, type of birth, episiotomy, perineal tears, sutures, and whether they would recommend the product to friends.

 

Verbal testimonies of positive outcomes from UK women were given and written feedback from ten women was available as ‘evidence’. Unfortunately, we were unable to report from this data as it would have been unethical to do so without gaining written consent from the women.However, the company’s advertising literature includes personal testimonies from professionals and women (Tecsana, 2005).

 

Searching for evidence

A basic internet search and a structured academic search with a trained university librarian were undertaken.

 

Basic internet search

The key words ‘EPI-NO birth trainer’ and ‘EPI-NO research’ were selected and entered into the search engines MSN, Ask Jeeves and Google Scholar. MSN brought up 640 hits, Ask Jeeves produced 285 and Google Scholar four. It became apparent that much information was replicated and the same claims for outcomes were repeated on Ask Jeeves and MSN. For example: ‘EPI-NO is clinically proven to:

  • Reduce the incidence of an episiotomy or perineal tear from natural birth

  • Increase Apgar score (rating for a newborn’s health)

  • Decrease the need for drugs during birth Reduce the parturition phase of birth (resulting in less stress for the baby)’.

 

The following testimonial was cited on Ask Jeeves and Google over 50 times: ‘Through training with EPI-NO, the need for episiotomy and the spontaneous perineum tear rate have sunk significantly. The expulsion phase has – in more than 70% of all births – been shortened by at least half the expected time. The anxiety many pregnant women have concerning the ‘passage of the head’ is discussed and can already be dissipated before the birth.Many women speak after the birth of a ‘recognition effect’ during delivery of the head because of their training with EPI-NO.

 

‘Based on several years of experience, we can warmly recommend the EPI-NO pelvic floor trainer to every pregnant woman as preparation for the birth as well as after the birth for help in childbirth recovery. (Excerpt of letter from qualified midwife Irmgard Hummler, Arco Maternity Clinic and Midwife Practice).’

 

The Google Scholar search provided four references, three of which related to the same German study by Schuchardt et al in 2000 and a more recent one by Kovacs et al in 2004. The Schuchardt study was a prospective pilot of 50 primiparous women with a matched control. The Kovacs study was also a pilot with 48 women in a birthing unit beingcompared to all other primigravidae who gave birth at the same time. Our major concern was the possibility that these pilot studies were being presented as clinical evidence. Therefore, a more structured literature search was done.

 

OVID, ‘Web of knowledge’, PUBMED and the Cochrane controlled trials register were searched using mesh headings of ‘EPI-NO and childbirth’ and ‘EPI-NO birth trainer’.

 

Evidence from published studies

 We reviewed four reports of clinical studies with EPI-NO, plus one MD thesis reporting a controlled clinical trial (see Table 1). The evidence these provided for the four specific ‘clinically proven’ claims was then considered.

 

Perineal injuries and episiotomies

Kovacs (2004) and Schuchardt (2000) both report significantly higher rates of intact perineum after delivery (Kovacs 46% compared to 17%, Schuchardt 48% versus 8.5%). However, these differences were not confirmed in the remaining studies, all of which showed no significant difference between the groups. It is noteworthy that the two randomised European studies reported substantially higher rates of intact perineum in the EPI-NO group (Münch 39% in comparison to 24% and Dannecker 47% to 41%). Kok et al also report the observation that the degree of perineal injury appeared to be less in the EPI-NO group, and Münch reports a lower rate of labial damage (19% versus 35%) with an associated p-value of 0.06.

Both Kok and Schuchardt report significant reductions in the episiotomy rate for the EPINO group.No such differences were seen in the remaining studies, and it is notable that the two studies showing a difference reported substantially higher episiotomy rates in the control group than did the remaining studies (Kok 93.3%, Schuchardt 78%).

 

Apgar score

The Schuchardt study showed an increase in the one and five minute Apgar scores in the EPI-NO group. Only two of the remaining studies reported Apgar scores (Kovacs and Münch) – in both they reported that no significant differences were seen between the groups.

 

Requirement for drugs during birth

Schuchardt reports that significantly fewer women in the EPI-NO group required peridural analgesia (14% compared to 29%). The only other study reporting the comparison (Münch) found no significant difference between the groups (26% versus 28%).

 

Second stage of labour

 Schuchardt found a significantly shorter second stage of labour (29 minutes versus 54 minutes). This was not confirmed by either of the other studies reporting on this (Münch and Kovacs).

 

Safety and long-term outcomes

No significant vaginal infections or other adverse experiences were reported. The studies all report that EPI-NO was generally perceived as very acceptable by the majority of women. Dannecker et al (2004) report the results of a questionnaire (63 EPI-NO group respondents, 58 control group) and clinical examination (59 EPI-NO group, 51 control group) performed six to eight months after birth.No significant difference was found with respect to bladder or pelvic floor function between the two groups.

 

Discussion and recommendations

In summary, little support was found for the claims of ‘proven clinical effectiveness’ given for EPI-NO, claims that rely too heavily on the results of one, possibly non-randomised study. It is possible that larger randomised studies would provide stronger evidence for some or all of the claims, particularly regarding the prevention of perineal injury or the lessening of its severity, the claim for which existing evidence is strongest.

 

Our recommendation concerning EPI-NO is that one or more randomised controlled trials should be performed in primaegravid women. These studies should be assessor-blind, and have adequate power to confirm or refute the specific clinical claims, all of which we argue have not yet been proven. Since Class I devices such as EPI-NO do not require evidence of efficacy to be CE-marked or offered for sale, we believe professionals have a responsibility to act as ‘guardians’ for all devices, particularly something such as this, and to be confident with the evidence. The performance of adequate pre-marketing controlled trials should also be encouraged.

 

Finally, any such studies (randomised or not) should be reported according to the CONSORT statement (www.consort-statement.org) and preferably registered with the International Standard Randomised Controlled Trial Number register (http://isrctn.org) to allow them to be found easily by future reviewers.

 

 

References

Dannecker C, Baur C, Ruckhaberle E, Peschers U, Jundt K, Reich A, Bauerle M, Schneider KTM, Hepp H. (2004) Einfluss des Geburtstrainers EPI-NO auf die mutterliche Beckenbodenfunktion sechs Monate nach Entbindung – Follow-up einer prospektiven und randomisierten Studie. Geburtshilfe und Frauenheilkunde 64: 1192-8.

 

Kok J, Tan KH, Koh S, Cheng PS, Lim WY, Yew ML, Yeo GS. (2004) Antenatal use of a novel vaginal birth-training device by term primiparous women in Singapore. Singapore Medical Journal 45(7): 318-23.

 

Kovacs GT, Heath P, Heather C. (2004) First Australian trial of the birth-training device EPINO: a highly significantly increased chance of an intact perineum. Australian and New Zealand Journal of Obstetrics and Gynaecology 44(4): 347-8.

 

Münch N. (2004) Prospektive Multizenterstudie zur Auswirkung des Geburtstrainers EPI-NO auf das outcome von Erstgebärenden. MD Dissertation from the Technischen Universität,Munich.

 

Medical and Healthcare Products Regulatory Agency Device Regulations. (2005) How we regulate devices. See: www.mhra.gov.uk/home/ idcplg?IdcService=SS_GET_PAGE&nodeId=48 (accessed December 2005).

 

Schuchardt R, Hillebrenner J, Hoffmann S, Horkel W, Schelling M, Schneider KTM. (2000) Birth preparation with a novel birth training device – presented at Kongress der Deutschen Gesellschaft für Pränatal und Geburtsmedizin, Nurenberg.

 

Tecsana. (2005) A gentle start to life. See: www. epi-no.com/birth (accessed December 2005).

 

Tecsana. (2005) Experiences of pregnant women and midwives with EPI-NO. See: www. epi-no.com/birth (accessed December 2005). 

 

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