4 vs 7 Points Blood Glucose Monitoring in Gestational Diabetes on Dietary Modification

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

4 Versus 7 Points Self-monitoring Blood Glucose in Gestational Diabetes on Diet Modification-A Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04101396
• Other study ID #: FF-2019-351
• Status: Completed
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2023
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare between 4 and 7 points blood glucose monitoring in women with gestational diabetes on diet modification.

Description:

All women with gestational diabetes on diet modification will be recruited and randomised to 4 versus 7 points self monitoring blood glucose. They will be followed up 4 weekly and the pregnancy outcomes will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Aged 18-45 years old
• Pregnant women with gestational diabetes mellitus on diet modification
• Confirmed gestational diabetes mellitus using National Institute for Health and Care Excellence guideline by 75g oral glucose tolerance test after 14 weeks
• Gestational age at recruitment 20-34 week

Exclusion Criteria:

• bad obstetrics history.
• Women with underlying medical disorders such as hypertension, autoimmune diseases on steroids
• fetal anomaly.
• Women planning to deliver in other centres
• Women who refuse to participate

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Dietary Supplement:
• diabetic diet
Patients with gestational diabetes will be seen by the dietitian to be taught diet modification

Locations

Country	Name	City	State
Malaysia	Antenatal clinic, UKM Medical Centre	Cheras	Kuala Lumpur
Malaysia	National University of Malaysia	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy outcome of participants	Mean gestational age at delivery in weeks	From date of randomisation up to 40 weeks gestation
Primary	Pregnancy outcome of participants	Rate of spontaneous or induced labour in percentage	From date of randomisation up to 40 weeks gestation and participants are diagnosed in established labour
Primary	Pregnancy outcome of participants	Rate of vaginal, instrumental or caesarean delivery in percentage	From date of randomisation up to 40 weeks gestation when the participants had given birth to the newborn
Primary	Pregnancy outcome of participants	Rate of intrapartum complications such as postpartum haemorrhage, shoulder dystocia and third or fourth degree tear in percentage	From date of randomisation up to 40 weeks gestation during progress of labour up to 24 hours post delivery
Primary	Pregnancy outcome of participants	Mean neonatal birth weight in kilogram	At the point of birth of the neonate
Primary	Pregnancy outcome of participants	Rate of neonates born with Apgar score at five minutes of less than 7 in percentage	At the point of birth of the neonate
Primary	Pregnancy outcome of participants	Rate of neonatal intensive care unit admission in percentage	At the point of birth of the neonate
Primary	Pregnancy outcome of participants	Rate of neonatal complications such as intrauterine fetal demise, neonatal death, neonatal hypoglycaemia, neonatal jaundice, neonatal respiratory distress syndrome and neonatal sepsis in percentage	From date of randomisation up to 7 days after birth of the neonate
Primary	Demographic data of participants	Mean age of participants in years	On the date of randomisation
Primary	Demographic data of participants	Rate of each different races such as Malay, Chinese and Indian in percentage	On the date of randomisation
Primary	Demographic data of participants	Rate of parity such as nulliparous or multiparous in percentage	On the date of randomisation
Primary	Demographic data of participants	Mean prepregnancy body mass index in kg/m^2	On the date of randomisation up to 40 weeks gestation based on the first trimester weight documented in the antenatal record
Primary	Demographic data of participants	Mean total weight gain in kilogram	On the date of randomisation till 40 weeks gestation
Primary	Demographic data of participants	Rate of positive family history of diabetes mellitus in percentage	On the date of randomisation up to 40 weeks gestation
Primary	Demographic data of participants	Rate of previous pregnancy affected by gestational diabetes mellitus in percentage	On the date of randomisation up to 40 weeks gestation
Primary	Demographic data of participants	Rate of previous pregnancy complicated by fetal macrosomia in percentage	On the date of randomisation up to 40 weeks gestation
Primary	Clinical characteristics of participants	Mean gestational age gestational diabetes mellitus is diagnosed in weeks	On the date of randomisation up to 40 weeks gestation
Primary	Clinical characteristics of participants	Mean fasting glucose level from the modified glucose tolerance test in mmol/l	On the date of randomisation up to 40 weeks gestation
Primary	Clinical characteristics of participants	Mean two hours post 75 gram glucose load from the modified glucose tolerance test in mmol/l	On the date of randomisation up to 40 weeks gestation
Primary	Clinical characteristics of participants	Rate of antenatal complications such as preeclampsia, threatened preterm labour, preterm prelabour rupture of membranes, anaemia,	At the point of randomisation till 40 weeks gestation
Primary	Clinical characteristics of participants	Mean level of glycosylated haemoglobin in percentage	At the point of randomisation till 40 weeks gestation
Primary	Clinical characteristics of participants	Mean level of serum fructosamine in percentage	At the point of randomisation till 40 weeks gestation
Primary	Clinical characteristics of participants	Mean level of fasting blood glucose in self monitoring blood glucose in mmol/l	At the point of randomisation till 40 weeks gestation
Primary	Clinical characteristics of participants	Mean level of pre-meal blood glucose in self monitoring blood glucose in mmol/l	At the point of randomisation till 40 weeks gestation
Primary	Clinical characteristics of participants	Mean level of one hour post-meal blood glucose in self monitoring blood glucose in mmol/l	At the point of randomisation till 40 weeks gestation
Secondary	Requirement of treatment in participants	Mean gestational age that the participants are detected to require added treatment in weeks	From the date of randomisation up to 40 weeks gestation
Secondary	Requirement of treatment in participants	Rate of type of treatment needed such as oral hypoglycaemic agent only, combination of insulin and oral hypoglycaemic agent	From point of randomisation till 40 weeks gestation
Secondary	Participants' compliance	Rate of frequency of four weekly self blood glucose monitoring in percentage	From point of randomisation till 40 weeks gestation
Secondary	Participants' satisfaction	Rate of participants' satisfaction whether satisfied, neutral or not satisfied in percentage	From point of randomisation till 40 weeks gestation