Investigation and management of diabetes during pregnancy

Not yet recruiting

Conditions: Gestational diabetes mellitus,

Registration Number: CTRI/2020/06/025807

Lead Sponsor: Jawaharlal Institute of Post graduate Medical Education and Research JIPMER

Brief Summary: This study is an interventional, comparative studyassessing the effect of yoga practice on cardiovascular risks in 176 GDM women. The study will be conducted in twoyears in JIPMER Hospital, Puducherry, India. Anthropometricmeasurements, HRV, BRS, body composition will be recorded and blood will becollected to assess metabolic parameters. Study group participants will undergoyoga therapy till 36 weeks of gestation/delivery. Control group participantswill not receive intervention. Above mentioned parameters will be assessed atthe end of 36 weeks of gestation for both the groups. The participants will befollowed till 48 hours postpartum for recording fetomaternal outcomes.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 176

Inclusion Criteria

Newly diagnosed GDM cases The upper limit of gestational age of GDM cases is 28th completed week of gestation Women with GDM receiving insulin and/or oral anti-diabetic drugs (cases and controls) Women with GDM willing to practice yoga (only for cases).

Exclusion Criteria

Severe anemia (cases and controls) Polyhydramnios (cases and controls) Multiple pregnancy (cases and controls) Pregnancy induced hypertension (PIH) (cases and controls) Cardiac problems (cases and controls) GDM women with the history of PCOS on metformin treatment BMI > 35 Kg/m2 (cases and controls) Patients undergoing any kind of yoga therapy or structured exercise (cases and controls) Patients who are not fit for practicing yoga which includes musculoskeletal problems (Cases) Patients not willing to deliver in JIPMER (cases and controls).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of supplementing yoga on cardiometabolic risks among pregnant women with Gestational Diabetes Mellitus.	2 time points. \| Initially as soon as the subjects are recruited and 2nd time assessment will be done at 36th weeks of gestation
To assess the effect of supplementing yoga on fetomaternal outcomes among pregnant women with Gestational Diabetes Mellitus	2 time points. \| Initially as soon as the subjects are recruited and 2nd time assessment will be done at 36th weeks of gestation

Secondary Outcome Measures

Name	Time	Method
To identify the association of cardiometabolic risks with fetomaternal outcomes among pregnant women with GDM	24-36 weeks

Trial Locations

Locations (1): JIPMER
🇮🇳
Pondicherry, PONDICHERRY, India
JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
Dr G K Pal
Principal investigator
9344291160
drgkpal@gmail.com