Effect of Lifestyle Modification on Pregnancy Outcome for GDM

Not Applicable

Completed

• Conditions: GDM; Lifestyle; Pregnancy Outcome
• Interventions: Behavioral: lifestyle modification (dietary modification); Behavioral: lifestyle modification (physical activity); Behavioral: lifestyle modification( self glucose monitoring)

• Registration Number: NCT05355038
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-11-11
• Primary Completion: 2021-08-28
• Status Verified: 2022-03
• Study Completion: 2022-03-21
• Study First Submitted: 2022-04-02
• Study First Submitted QC: 2022-04-24
• Last Update Submitted: 2022-04-24
• Study First Posted: 2022-05-02
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lifesyle modification	lifestyle modification (dietary modification)	intervention group will take lifestyle modification protocol which composed of health teaching about low glycemic index diet, physical activity and self glucose monitoring
lifesyle modification	lifestyle modification (physical activity)	intervention group will take lifestyle modification protocol which composed of health teaching about low glycemic index diet, physical activity and self glucose monitoring
lifesyle modification	lifestyle modification( self glucose monitoring)	intervention group will take lifestyle modification protocol which composed of health teaching about low glycemic index diet, physical activity and self glucose monitoring

Primary Outcome Measures

Name	Time	Method
effect of lifestyle modification among GDM on pregnancy outcome	from 28 weeks of gestational until the first 24hours postpartum	assessment of fasting blood sugar and random blood sugar for the postpartum GDM women and their neonatal in the first 24 hours postpartum by using (fasting blood sugar (FBS) and random blood sugar (RBS) measured with digital blood glucose monitoring by using test strips

Trial Locations

Locations (1)

Faculty of Nursing; 🇪🇬 Cairo, Egypt