Evaluation of the effect of an antenatal pelvic floor muscle exercise programme on female sexual function during pregnancy and the first 3 months following birth: study protocol for a pragmatic randomised controlled trial

BACKGROUND: Sexual dysfunction can have a negative impact on women’s quality of life and relationships. There is limited information about female sexual function and treatment, particularly during pregnancy and the postpartum period. The effect of pelvic floor muscle exercise (PFME) on sexual function (SF) has not been studied adequately. The purpose of this study is to investigate the effect of antenatal PFME on female SF during pregnancy and the first 3 months following birth. METHODS/DESIGN: This is a pragmatic, randomised controlled trial which will compare a structured antenatal PFME programme combined with standard antenatal care to standard antenatal care alone. Eligible women who are less than 22 weeks’ gestation will be recruited from the antenatal clinics of one hospital located in Western Sydney, Australia. A sample of 200 primiparous pregnant women who meet the inclusion criteria will be randomised to either control or intervention groups. This sample size will allow for detecting a minimum difference of 9% in the female SF score between the two groups. The duration of the PFME programme is from approximately 20 weeks’ gestation until birth. Female SF will be measured via questionnaires at < 22 weeks’ gestation, at 36 weeks’ gestation and at 3 months following birth. Baseline characteristics, such as partner relationship and mental health, will be collected using surveys and questionnaires. Data collected for secondary outcomes include the effect of PFME on childbirth outcomes, urinary and faecal incontinence symptoms and quality of life. DISCUSSION: The findings of this study will provide more information on whether a hospital-based antenatal PFME has any effect on female SF, urinary and faecal incontinence during pregnancy and the first 3 months following birth. The study will also provide information on the effectiveness of antenatal PFME on childbirth outcomes. TRIAL REGISTRATION: Australian New Zealand Clinical Trials registry, ACTRN12617001030369. Registered on 17 July 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3226-6) contains supplementary material, which is available to authorized users.