Diabetes mellitus arising in pregnancy Pregnancy
Conditions
Interventions
This is a feasibility study for a four-arm, simple-blind clinical trial, with blinding of the outcome assessor and the statistician. The intervention under study consists of a hydrotherapy protocol pe
(2) pregnant women with gestational diabetes mellitus not undergoing hydrotherapy (G-DS)
(3) normoglycemic pregnant women undergoing hydrotherapy (G-CH)
and (4) normoglycemic pregnant women not undergoing hydrotherapy (G-CS). Comparisons between the groups will allow for the assessment of the effects of hydrotherapy, gestational diabetes mellitus, and
Sponsors
Universidade Estadual Paulista "Julio de Mesquita Filho" - Faculdade de Medicina de Botucatu
Faculdade de Medicina de Marília
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Primigravidas and/or secundigravidas with a history of only cesarean delivery; gestational age between 24 and 28 weeks; aged 18 to 35 years; without gestational diabetes mellitus (to form Group C) or with a diagnosis of Gestational Diabetes Mellitus in the current pregnancy (to form Group D); and possessing authorization for hydrotherapy from the physician responsible for prenatal care, along with a copy of diabetes screening test results for Group D participants
Exclusion criteria
Exclusion criteria: Multiparous pregnant women; history of vaginal delivery; diagnosis of clinical diabetes or arterial hypertension; complaint of urinary incontinence prior to the current pregnancy; presence of contraindications for hydrotherapy; and presence of absolute contraindications for physical activity during pregnancy, such as: decompensated myocardial disease, congestive heart failure, thrombophlebitis, recent pulmonary embolism, acute infectious disease, risk of preterm birth, uterine bleeding, suspected fetal distress, severe isoimmunization, decompensated hypertensive disease, lack of prenatal care, placenta previa, signs of placental insufficiency, premature rupture of membranes, cervical incompetence, restrictive lung disease, multiparity with risk of prematurity, placenta previa after 26 weeks of gestation, ruptured membranes, incompetent cervix, and pre-eclampsia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: The aim is to understand the applicability of hydrotherapy and its impact on pelvic floor muscle function in pregnant women with gestational diabetes mellitus and normoglycemic pregnant women, through the assessment of pelvic floor muscle function using functional pelvic floor assessment, electromyography, ultrasound, and specific questionnaires;Outcome 1: The results demonstrated that hydrotherapy is a feasible intervention during pregnancy and has the potential to improve pelvic floor muscle function. However, the findings were insufficient to confirm consistent differences in pelvic floor muscle function between pregnant women with gestational diabetes mellitus and normoglycemic pregnant women. Therefore, further clinical trials with larger sample sizes and greater statistical power are needed to confirm the effects of hydrotherapy on pelvic floor muscle function and the differences between the groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: The aim is to evaluate and compare the function of the pelvic floor muscles during pregnancy and in the period of 4 to 6 months postpartum in pregnant women with gestational diabetes mellitus and normoglycemia, with or without hydrotherapy, through clinical and functional evaluation of the pelvic floor muscles, including bimanual palpation, perineometry, electromyography and ultrasound between the 24th and 28th gestational weeks, between the 36th and 38th gestational weeks and in the postpartum period;Outcome 1: Differences in pelvic floor muscle function were observed between the groups, as assessed by bidigital palpation, perineometry, and electromyography. The group with gestational diabetes mellitus and pregnancy-specific urinary incontinence exhibited lower pelvic floor muscle strength, as well as shorter contraction maintenance time and lower fast-twitch muscle fiber strength, as evidenced by electromyographic assessment;Expected outcome 2: The aim is to analyze and compare the quality of life and sexual function of pregnant women with gestational diabetes mellitus and normoglycemic pregnant women at different assessment time points—both within and between groups—using validated questionnaires, including the Female Sexual Function Index;Outcome 2: A difference between the groups was observed regarding sexual function, assessed using the Female Sexual Function Index; pregnant women with gestational diabetes mellitus had worse scores compared to normoglycemic pregnant women, indicating greater impairment of sexual function throughout pregnancy;Expected outcome 3: The aim is to analyze and compare the occurrence and severity of urinary incontinence during pregnancy and in the period of 4 to 6 months postpartum between pregnant women with gestational diabetes mellitus and normoglycemic pregnant women, using the International Consultation on Incontinence Questionnaire – Short Form in conjunction with an assessment of pelvic floor muscle function | — |
Countries
BR
Contacts
Public ContactMarilza Rudge
Universidade Estadual Paulista "Julio de Mesquita Filho" - Faculdade de Medicina de Botucatu
Outcome results
None listed