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Effect of Lifestyle Modification on Pregnancy Outcome for GDM

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Lifestyle
GDM
Pregnancy Outcome

Treatments

Behavioral: lifestyle modification (dietary modification)
Behavioral: lifestyle modification( self glucose monitoring)
Behavioral: lifestyle modification (physical activity)

Study type

Interventional

Funder types

Other

Identifiers

NCT05355038
Basma said Mahmoud El gamasy

Details and patient eligibility

About

Effect of lifestyle modification on pregnancy outcome for pregnant women with GDM

Full description

evaluate the effect of lifestyle modification on pregnancy outcome among GDM women.

Primary outcomes: excessive gestational weight gain, uncontrolled blood glucose level, PIH, polyhydromnios, oligohydrominos, recurrent monilia infection and urinary tract infection , intra uterine fetal death (IUFD), intra uterine growth restriction (IUGR), premature preterm rupture of membrane and Diabetic ketoacidosis.

Secondary outcomes: preterm labor, caesarian section, neonatal hypoglycemia, stillbirth, respiratory distress syndrome, small for gestational age (SGA), large for gestational age (LGA) ,neonatal intensive care unit (NICU) and failure to initiate or maintain breast feeding.

Enrollment

150 patients

Sex

Female

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • women diagnosed with GDM

Exclusion criteria

  • pre-gestational diabetes type 1 or type 2 diabetes mellitus, diagnosed as pregnancy induced hypertension before GDM

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 2 patient groups

lifesyle modification
Experimental group
Description:
intervention group will take lifestyle modification protocol which composed of health teaching about low glycemic index diet, physical activity and self glucose monitoring
Treatment:
Behavioral: lifestyle modification (physical activity)
Behavioral: lifestyle modification( self glucose monitoring)
Behavioral: lifestyle modification (dietary modification)
control group
No Intervention group
Description:
routine care of the hospital

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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