Study protocol to investigate biomolecular muscle profile as predictors of long-term urinary incontinence in women with gestational diabetes mellitus.


Journal

BMC pregnancy and childbirth
ISSN: 1471-2393
Titre abrégé: BMC Pregnancy Childbirth
Pays: England
ID NLM: 100967799

Informations de publication

Date de publication:
19 Feb 2020
Historique:
received: 26 10 2019
accepted: 17 01 2020
entrez: 21 2 2020
pubmed: 23 2 2020
medline: 2 12 2020
Statut: epublish

Résumé

Pelvic floor muscles (PFM) and rectus abdominis muscles (RAM) of pregnant diabetic rats exhibit atrophy, co-localization of fast and slow fibers and an increased collagen type I/III ratio. However, the role of similar PFM or RAM hyperglycemic-related myopathy in women with gestational diabetes mellitus (GDM) remains poorly investigated. This study aims to assess the frequency of pelvic floor muscle disorders and pregnancy-specific urinary incontinence (PS-UI) 12 months after the Cesarean (C) section in women with GDM. Specifically, differences in PFM/RAM hyperglycemic myopathy will be evaluated. The Diamater is an ongoing cohort study of four groups of 59 pregnant women each from the Perinatal Diabetes Research Centre (PDRC), Botucatu Medical School (FMB)-UNESP (São Paulo State University), Brazil. Diagnosis of GDM and PS-UI will be made at 24-26 weeks, with a follow-up at 34-38 weeks of gestation. Inclusion in the study will occur at the time of C-section, and patients will be followed at 24-48 h, 6 weeks and 6 and 12 months postpartum. Study groups will be classified as (1) GDM plus PS-UI; (2) GDM without PS-UI; (3) Non-GDM plus PS-UI; and (4) Non-GDM without PS-UI. We will analyze relationships between GDM, PS-UI and hyperglycemic myopathy at 12 months after C-section. The mediator variables to be evaluated include digital palpation, vaginal squeeze pressure, 3D pelvic floor ultrasound, and 3D RAM ultrasound. RAM samples obtained during C-section will be analyzed for ex-vivo contractility, morphological, molecular and OMICS profiles to further characterize the hyperglycemic myopathy. Additional variables to be evaluated include maternal age, socioeconomic status, educational level, ethnicity, body mass index, weight gain during pregnancy, quality of glycemic control and insulin therapy. To our knowledge, this will be the first study to provide data on the prevalence of PS-UI and RAM and PFM physical and biomolecular muscle profiles after C-section in mothers with GDM. The longitudinal design allows for the assessment of cause-effect relationships between GDM, PS-UI, and PFMs and RAMs myopathy. The findings may reveal previously undetermined consequences of GDM.

Sections du résumé

BACKGROUND BACKGROUND
Pelvic floor muscles (PFM) and rectus abdominis muscles (RAM) of pregnant diabetic rats exhibit atrophy, co-localization of fast and slow fibers and an increased collagen type I/III ratio. However, the role of similar PFM or RAM hyperglycemic-related myopathy in women with gestational diabetes mellitus (GDM) remains poorly investigated. This study aims to assess the frequency of pelvic floor muscle disorders and pregnancy-specific urinary incontinence (PS-UI) 12 months after the Cesarean (C) section in women with GDM. Specifically, differences in PFM/RAM hyperglycemic myopathy will be evaluated.
METHODS METHODS
The Diamater is an ongoing cohort study of four groups of 59 pregnant women each from the Perinatal Diabetes Research Centre (PDRC), Botucatu Medical School (FMB)-UNESP (São Paulo State University), Brazil. Diagnosis of GDM and PS-UI will be made at 24-26 weeks, with a follow-up at 34-38 weeks of gestation. Inclusion in the study will occur at the time of C-section, and patients will be followed at 24-48 h, 6 weeks and 6 and 12 months postpartum. Study groups will be classified as (1) GDM plus PS-UI; (2) GDM without PS-UI; (3) Non-GDM plus PS-UI; and (4) Non-GDM without PS-UI. We will analyze relationships between GDM, PS-UI and hyperglycemic myopathy at 12 months after C-section. The mediator variables to be evaluated include digital palpation, vaginal squeeze pressure, 3D pelvic floor ultrasound, and 3D RAM ultrasound. RAM samples obtained during C-section will be analyzed for ex-vivo contractility, morphological, molecular and OMICS profiles to further characterize the hyperglycemic myopathy. Additional variables to be evaluated include maternal age, socioeconomic status, educational level, ethnicity, body mass index, weight gain during pregnancy, quality of glycemic control and insulin therapy.
DISCUSSION CONCLUSIONS
To our knowledge, this will be the first study to provide data on the prevalence of PS-UI and RAM and PFM physical and biomolecular muscle profiles after C-section in mothers with GDM. The longitudinal design allows for the assessment of cause-effect relationships between GDM, PS-UI, and PFMs and RAMs myopathy. The findings may reveal previously undetermined consequences of GDM.

Identifiants

pubmed: 32075598
doi: 10.1186/s12884-020-2749-x
pii: 10.1186/s12884-020-2749-x
pmc: PMC7031907
doi:

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

117

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Auteurs

Marilza V C Rudge (MVC)

Department of Gynecology and Obstetrics, Botucatu Medical School (FMB), São Paulo State University (UNESP), CEP18618-687, Sao Paulo, Brazil. marilzarudge@gmail.com.

Fátima P Souza (FP)

Physics Department, Institute of Biosciences, Letters and Exact Sciences, Multiuser Center for Biomolecular Innovation, UNESP-São Paulo State University, Sao Paulo, Brazil.

Joelcio F Abbade (JF)

Department of Gynecology and Obstetrics, Botucatu Medical School (FMB), São Paulo State University (UNESP), CEP18618-687, Sao Paulo, Brazil.

Raghavendra L S Hallur (RLS)

Department of Gynecology and Obstetrics, Botucatu Medical School (FMB), São Paulo State University (UNESP), CEP18618-687, Sao Paulo, Brazil.

João Paulo C Marcondes (JPC)

Department of Gynecology and Obstetrics, Botucatu Medical School (FMB), São Paulo State University (UNESP), CEP18618-687, Sao Paulo, Brazil.

Fernanda Piculo (F)

Department of Gynecology and Obstetrics, Botucatu Medical School (FMB), São Paulo State University (UNESP), CEP18618-687, Sao Paulo, Brazil.
Physiotherapy Department, Faculdades Integradas de Bauru, FIB, Sao Paulo, Brazil.

Gabriela Marini (G)

Department of Gynecology and Obstetrics, Botucatu Medical School (FMB), São Paulo State University (UNESP), CEP18618-687, Sao Paulo, Brazil.
Universidade do Sagrado Coração (USC), Jardim Brasil, Bauru, Sao Paulo, Brazil.

Giovana Vesentini (G)

Department of Gynecology and Obstetrics, Botucatu Medical School (FMB), São Paulo State University (UNESP), CEP18618-687, Sao Paulo, Brazil.

Lehana Thabane (L)

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare-Hamilton, Hamilton, ON, Canada.

Steven S Witkin (SS)

Department of Obstetrics and Gynecology, Weill Cornell Medicine, New York, NY, USA.
Institute of Tropical Medicine, University of Sao Paulo Medical School, Sao Paulo, Brazil.

Iracema M P Calderon (IMP)

Department of Gynecology and Obstetrics, Botucatu Medical School (FMB), São Paulo State University (UNESP), CEP18618-687, Sao Paulo, Brazil.

Angélica M P Barbosa (AMP)

Department of Gynecology and Obstetrics, Botucatu Medical School (FMB), São Paulo State University (UNESP), CEP18618-687, Sao Paulo, Brazil.
School of Philosophy and Sciences, Department of Physiotherapy and Occupational Therapy, UNESP-São Paulo State University, Marília, Sao Paulo, Brazil.

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