Effect of Lifestyle Modification on Pregnancy Outcome for GDM

Lifestyle Clinical Trial

— Lifestyle  

Official title:

Effect of Lifestyle Modification on Pregnancy Outcomes for Pregnant Women With Gestational Diabetes: an Evidence Based.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05355038
• Other study ID #: Basma said Mahmoud El gamasy
• Status: Completed
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: March 21, 2022

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 21, 2022
• Est. primary completion date: August 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• GDM
• Lifestyle
• Pregnancy Outcome

Intervention

Behavioral:
• lifestyle modification (dietary modification)
low glycemic index diet the researcher gave detail information about (importance of LGI diet, component of food, number of meals and snake, example of food taken in breakfast, lunch, dinner and snake in between, food allowed and not allowed). After that, the researcher required from the woman to make an example of food for one day according to her income level, if correction of the content of food needed, the researcher will explain this point again.
• lifestyle modification (physical activity)
health teaching about choose between two types of exercise to be selected according to the ability of GDM women to perform : brisk walking or seated arm exercise or selected both. Brisk walking should be performed for at least half an hour three time /week, while, seated arm exercise done three time after each meal for10 minute in each time. The researcher given a detail information about both types and its importance in decreasing blood glucose level, also how to perform and what should be done in case of appearance of fatigue manifestation during exercise, and the women have choice for perform both or selected one to perform according to your health condition.
• lifestyle modification( self glucose monitoring)
self-glucose monitoring the researcher explain the important of monitoring blood glucose level and instruct the women about how to perform self- glucose measuring, recording way of the result in schedule and to bring this result in the next antenatal visit. The women who have digital blood glucose monitoring instructed to measure it at least 5 time/day. while, the women who didn't have digital blood glucose monitoring measure went to nearest pharmacy to measure blood glucose at least one time per day especially when the woman felt the signs and symptoms of hypo or hyperglycemia and recorded the result in paper or sent the result in whatsapp for the researcher if you have whatsapp application. In addition to give the woman instruction about sings symptoms of hypoglycemia and hyperglycemia and the proper ways for management

Locations

Country	Name	City	State
Egypt	Faculty of Nursing	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of lifestyle modification among GDM on pregnancy outcome	change blood glucose level (fasting blood sugar (FBS) and random blood sugar (RBS) measured with digital blood glucose monitoring by using test strips; HA1C and urine analysis done in the laboratory and get the result)	from 28 weeks of gestational until the first 24hours postpartum
Primary	effect of lifestyle modification among GDM on pregnancy outcome	attained proper weight gain during pregnancy. Weight was measured utilizing bath scale where the accuracy were obtained through balancing zero prior weighting	from 28 weeks of gestational until the first 24hours postpartum
Primary	effect of lifestyle modification among GDM on pregnancy outcome	occurrence of maternal complications during pregnancy((preeclampsia, urinary infection, monilia infection, premature rupture of membrane, bleeding during pregnancy, and diabetic ketoacidosis).this will recorded by using tool to assess this compilication	from 28 weeks of gestational until the first 24hours postpartum
Primary	effect of lifestyle modification among GDM on pregnancy outcome	occurrences of fetal complications during pregnancy detected by the result of ultrasound done by physician (decrease fetal movement count, IUGR, and IUFD)	from 28 weeks of gestational until the first 24hours postpartum
Primary	effect of lifestyle modification among GDM on pregnancy outcome	Intrapartum assessment of the outcomes. The researcher assessed mode of delivery and complications occurrence to the GDM women and their neonatal during intrapartum from the hospital filling . The maternal complications (preterm labor, prolonged labor, traumatic labor, intrapartum instrumental delivery, perineal trauma or tear, postoperative hemorrhage and infection). While regarding to fetal assessment (occurrences of intra uterine fetal death, preterm birth, Birth trauma (shoulder dystocia, bone fracture, cerebral palsy), fetal distress, macrosomia, IUGR, five-minute Apgar less than seven, stillbirth)	from 28 weeks of gestational until the first 24hours postpartum
Primary	effect of lifestyle modification among GDM on pregnancy outcome	Postpartum assessment of the outcomes.The researcher assessed each woman and their newborn for the first 24 hours postpartum in both groups. It included the following items:1) assessed maternal vital sings: Temperature was assessed by using thermometer; blood pressure was measured through a sphygmomanometer; 2) maternal and newborn lab investigation as FBS and postprandial using digital blood glucose monitoring with test strips.; In addition to, assess the occurrences of Maternal and newborn complications as; postpartum hemorrhage, failure or delay for initiating breastfeeding, neonatal hypoglycemia, respiratory distress syndrome, sings of jaundice, (SGA or LGA), neonatal death, and neonatal administration to ICU, and preterm birth.	from 28 weeks of gestational until the first 24hours postpartum
Primary	effect of lifestyle modification among GDM on pregnancy outcome	newborn gestational age. assessment of the neonatal anthropometric measurements such as weight which taken from labor sheet, length was measured from head to toe when the neonates were in supine position and legs were extended using measurement tap. Then, measured head circumference through measurement tape firmly around head above the eyebrow ridge. The researcher plotted neonatal weight, length and head circumference by gestational age on the growth chart, to determine if the growth below 10th percentile the neonate was small for gestational age (SGA), if the growth above the 90th percentile, the neonates was large for gestational age (LGA) called macrocosmic baby, if the growth was in between 10th and 90th percentiles, the neonates was appropriate for gestational age (AGA). Postpartum assessment taken 30 minutes for each woman in each group.	from 28 weeks of gestational until the first 24hours postpartum
Primary	effect of lifestyle modification among GDM on pregnancy outcome	body mass index(was calculated through the formula "weight in Kg, divided by height squared in meters"; class of weight using the international classification of adult underweight<18.5, normal weight 18.5-24.9, over weight 25-29.9 and obesity = 30 according to BMI )	from 28 weeks of gestational until the first 24hours postpartum
Primary	effect of lifestyle modification among GDM on pregnancy outcome	height measured by using measurement tape. firstStand with your feet flat on the floor with your heels against the corner where the wall and floor meet. Make sure your head, shoulders, and buttocks are touching the wall. then use Use a tape measure - - to measure the distance from the floor to the mark on the wall.; Stand up straight with your eyes looking straight ahead. Your line of sight and chin should be parallel to the floor.	from 28 weeks of gestational until the first 24hours postpartum
Primary	effect of lifestyle modification among GDM on pregnancy outcome	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	from 28 weeks of gestational until the first 24hours postpartum