RecruitingACTRN12618001353280

My Birth Course: An antenatal course of Complementary Medicine (CM) techniques for labour and birth for women having their first baby: a randomized controlled trial.

My Birth Course: An antenatal package of Complementary Medicine (CM) techniques for labour and birth examining epidural use in primiparous women: a randomized controlled trial.

Sponsor

University of South Australia

Enrollment

200 participants

Start Date

Sep 4, 2018

Study Type

Interventional

Conditions

Medical interventions childbirth Pregnancy Childbirth Labour

Summary

The aim of this research is to translate the low-cost ‘Integrative Medicine for Labour & Birth Program’ (My Birth Course) into end-user benefit and to inform health service delivery. The study will be conducted as a randomised controlled trial (RCT). Randomisation will occur between 24-36 weeks’ gestation. Women will be enrolled into the My Birth Course (antenatal education program), in addition to standard care, or receive standard care alone. This RCT will contribute to a prospective meta-analysis design to assess clinical effectiveness and quantify resource use that will affect translation into practice and sustainability. This study extends the finding of the original RCT conducted in Sydney, Australia which demonstrated significant reductions in caesarean section and medical interventions. The unique contribution of this proposal is to extend the generalisability of the findings by recruiting women from a more diverse group of women at a different hospital to determine the real-world effectiveness of an antenatal education intervention when it is delivered through a range of maternity units in Australia and internationally.

Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Having your first baby is one of the most significant events in a person's life, and the experience of labour and birth can be deeply affected by how prepared and confident a woman feels going in. This study is testing a program called 'My Birth Course' — an antenatal education program that teaches women expecting their first child a range of complementary medicine techniques to help manage pain and stress during labour, such as breathing, acupressure, and relaxation methods. Pregnant women between 24 and 36 weeks who are expecting their first baby will be randomly assigned to either attend the My Birth Course program on top of standard antenatal care, or receive standard care alone. The trial will track birth outcomes including whether the techniques used influenced rates of caesarean section and medical interventions during labour. You may be eligible if you are pregnant with your first baby (singleton pregnancy), are between 24 and 36 weeks gestation, have a low-to-moderate risk pregnancy, and have sufficient English to participate in the workshops. High-risk pregnancies or women already enrolled in a similar complementary birth program would not be eligible.

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Interventions

My Birth Course is an antenatal education package consisting of 5 different non-pharmacological (complementary therapy) techniques for the management of pain in normal labor and birth. The workshops are educational sessions with interactive practice of techniques learned over the course. The following concepts and techniques are introduced to the woman during the course: the physiology of birth, the fear-pain-tension cycle, working with pain, the relaxation response, guided visualization and relaxation, active birth- movement, yoga and positions for birth, accupressure, breathing and massage techniques. Duration of treatment: Participation in a 2-day weekend or a series of 4x (2.5h) evening workshops from 24-36 weeks gestation. Participants can choose which of the scheduled workshops (whether weekend or evening) they wish to attend. Participants document a practice worksheet outlining the tools and techniques (when/where/with whom) they will practice to prepare for labour and birth. Participants are instructed to practice their chosen technique/s regularly but are not prescribed any specific duration or frequency of time to practice. The workshop will run twice per month over 10-12 months or until recruitment has been achieved. The workshops will be held at the University of South Australia (west campus) Health Clinic. The workshops will be delivered by expert midwifery educators with a minimum of 5 years experience each. Follow-up will occur within 72 hours of birth. At this time point participants will self report time spent practicing the (complementary therapies) techniques used for labour and birth.