Effects of Perineal Massage During Pregnancy on Women's Health

This non-randomized controlled trial has the sample target of 75 women analysed, at least, between January and May 2020.

The following inclusion criteria were defined to participate in the study: (a) women between 18 and 40 years of age; (b) full term delivery (37th week or more); (c) single gestation and with cephalic presentation; (d) pregnancy with no complications, nor added risks during gestation; (e) no participation in any other psychoprophylaxis intervention; (f) deliver at the Hospital Nuestra Señora de Sonsoles (Spain). The following exclusion criteria were simultaneously defined: (a) any contraindication for perineal massage and/or vaginal delivery; (b) medical diagnosis of any urogynecologi-cal pathology previous to gestation process; (c) any records of cesarean delivery and/or history of perineal injury and/or urinary incontinence; (d) not giving informed consent of participation in the study or lack of attendance to every programmed intervention and/or evaluation session.

Approval for the study was obtained through the Ethics Committee of the University of Leon, Spain (code: ETICA-ULE-021-2018). All participants signed an informed consent form, in accordance with the Declaration of Helsinki (rev. 2013), and had the option to revoke their participation in the study at any time. Ethical regulations were respected as well as the Spanish Law for Protection Data Organic Law and for Biomedical Research in Human Participants.

Methodology The interventions include: (a) perineal massage and EPI-NO® device group, applied by an expert physiotherapist; (b) self-massage group, where women were instructed to apply perineal massage in domestic household; and (c) a control group, which received ordinary obstetric attention. Groups were not randomized since the priority was the wellbeing of the pregnant par-ticipant and were assigned according to the participant's preferences (attendance at the medical centre for physiotherapy treatment, self-massage at home or attendance at childbirth preparation sessions only).

Data collection took place during an evaluation session on the fifth- or sixth- postpartum week through a self-reported form where participants registered the characteristics of delivery (gestation week, baby's weight, duration and posture of de-livery, tear, episiotomy, use of equipment and/or analgesia). The form also included a question on intensity of perineal pain at the time of evaluation (quantified by visual analogue scale).