Clinical trial NCT05355038: Effect of Lifestyle Modification on Pregnancy Outcome for GDM
Official title: Effect of Lifestyle Modification on Pregnancy Outcomes for Pregnant Women With Gestational Diabetes: an Evidence Based.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GDM
Lifestyle
Pregnancy Outcome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: control and study group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: effect of lifestyle modification among GDM on pregnancy outcome
timeFrame: from 28 weeks of gestational until the first 24hours postpartum
measure: effect of lifestyle modification among GDM on pregnancy outcome
timeFrame: from 28 weeks of gestational until the first 24hours postpartum
measure: effect of lifestyle modification among GDM on pregnancy outcome
timeFrame: from 28 weeks of gestational until the first 24hours postpartum
measure: effect of lifestyle modification among GDM on pregnancy outcome
timeFrame: from 28 weeks of gestational until the first 24hours postpartum
measure: effect of lifestyle modification among GDM on pregnancy outcome
timeFrame: from 28 weeks of gestational until the first 24hours postpartum
measure: effect of lifestyle modification among GDM on pregnancy outcome
timeFrame: from 28 weeks of gestational until the first 24hours postpartum
measure: effect of lifestyle modification among GDM on pregnancy outcome
timeFrame: from 28 weeks of gestational until the first 24hours postpartum
measure: effect of lifestyle modification among GDM on pregnancy outcome
timeFrame: from 28 weeks of gestational until the first 24hours postpartum
measure: effect of lifestyle modification among GDM on pregnancy outcome
timeFrame: from 28 weeks of gestational until the first 24hours postpartum
measure: effect of lifestyle modification among GDM on pregnancy outcome
timeFrame: from 28 weeks of gestational until the first 24hours postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Nursing
Study officials:
References: