Pelvic Floor Muscle Training During Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Southern Denmark
About this trial
The project seeks to investigate effectiveness of PFMT during pregnancy.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Woman in the 1st trimester of pregnancy (up to 12+6 weeks of gestation)
Para 0 (no previous birth or pregnancy > 16 weeks of gestation)
Understands, writes, and reads fluently in Danish or English
Has a smart phone or computer/tablet to reach the training program
Disqualifiers
Severe psychiatric illness (e.g. schizophrenia, bipolar disorder, severe depression or anxiety)
Active substance abuse
Acute social crises (e.g. homelessness, ongoing domestic violence, severe financial instability, lack of social support)
Women with limited capacity to provide informed consent (due to cognitive impairment or language barriers)
Trial design
Design model
Parallel
Treatments tested in this trial
PFMT
BehavioralThe motivation-informed intervention will tackle both exercise engagement and exercise adherence. Participating women will be introduced to the app and its videos following training. The participants will be introduced not only to muscle training, but also to muscle relaxation. The training will be recommended three to four times a week during pregnancy with further continuity after giving birth.
Standard care
BehavioralStandard care
Treatment groups
734 Participants
are divided into 2 treatment groupsGroup A: Pelvic Floor Muscle Training (PFMT)Experimental treatment 1 intervention
Group B: Standard carePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Urinary incontinence (UI) incidence at 3 months postpartum
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score between 0 (perfect continence) and 21 (total incontinence).
Time frame
At 3 months follow-up after giving birthSecondary outcomes
1
Urinary incontinence at the 1st trimester of pregnancy
ICIQ-UI SF score between 0-21
Time frame
At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days)2
Urinary incontinence at the 2nd trimester of pregnancy
ICIQ-UI SF score between 0-21
Time frame
At the follow-up at Gestational age 26 weeks and 0 days3
Urinary incontinence incidence at the 3rd trimester of pregnancy
ICIQ-UI SF score between 0-21
Time frame
At the follow-up at Gestational Age 36 weeks and 0 days4
Urinary incontinence incidence at 6 weeks postpartum
ICIQ-UI SF score between 0-21
Time frame
At the follow-up at 6 weeks postpartumSponsors and contacts
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Source ClinicalTrials.gov