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Remote Monitoring for Pelvic Floor Muscle Strengthening in Pregnant Diabetic Women

Use of Telemonitoring to Train the pelvic floor muscles of Diabetic pregnant women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9qm8wqh
Enrollment
Unknown
Registered
2024-08-26
Start date
2024-09-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes, Pelvic Floor

Interventions

This is a randomized, controlled and single-blind clinical trial type study. It will consist of two groups, the Comparator Group (CG) and the Exercise Group (GE), each group will consist of 20 women,
E02.831.535

Sponsors

Universidade Federal do Rio Grande do Norte - Lagoa Nova Campus Central
Lead Sponsor
Maternidade Escola Januário Cicco
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women; age between 18 and 45 years; diagnosis of Gestational Diabetes Mellitus, according to the criteria of the World Health Organization; gestational age between 14 and 21 weeks identified by first-trimester ultrasound; having attended a maximum of three consultations in High-Risk Prenatal Care; medical clearance to perform exercise; access to a smartphone; interest in participating in any of the interventions

Exclusion criteria

Exclusion criteria: Prescription of insulin therapy upon recruitment; multiple pregnancy; chronic arterial hypertension at recruitment; pre-eclampsia at recruitment; history of intrauterine fetal death or multiple miscarriages; orthopedic limitation; alcohol consumption doses of alcohol per week; smoking; neurological, language, hearing and/or visual limitations that may make participation in the study difficult

Design outcomes

Primary

MeasureTime frame
Functionality measured by vaginal manometry—

Secondary

MeasureTime frame
Pelvic floor muscle strength measured by the Modified Oxford Scale;Symptoms of pelvic floor disorders using the Pelvic Floor Distress Inventory;Symptoms of pelvic floor disorders using the Pelvic Floor Impact Questionnaire-short form 7;Urinary incontinence by the International Incontinence Consultation Questionnaire - Short Form;Sexual function assessed by the Function Sexual Female Index;Degree of satisfaction assessed by the Patient Global Impression of Change—

Countries

Brazil

Contacts

Public ContactMaria Thereza Cabral Micussi

Universidade Federal do Rio Grande do Norte

thereza.micussi@ufrn.br+55-84-999865469

Outcome results

None listed

Source: REBEC (via WHO ICTRP)