Clinical trial NCT04101396: 4 vs 7 Points Blood Glucose Monitoring in Gestational Diabetes on Dietary Modification
Official title: 4 Versus 7 Points Self-monitoring Blood Glucose in Gestational Diabetes on Diet Modification-A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Keywords: diet modification, 4 and 7 points monitoring
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All women with gestational diabetes are randomised to 4 or 7 points of self monitoring blood glucose.
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy outcome of participants
timeFrame: From date of randomisation up to 40 weeks gestation
measure: Pregnancy outcome of participants
timeFrame: From date of randomisation up to 40 weeks gestation and participants are diagnosed in established labour
measure: Pregnancy outcome of participants
timeFrame: From date of randomisation up to 40 weeks gestation when the participants had given birth to the newborn
measure: Pregnancy outcome of participants
timeFrame: From date of randomisation up to 40 weeks gestation during progress of labour up to 24 hours post delivery
measure: Pregnancy outcome of participants
timeFrame: At the point of birth of the neonate
measure: Pregnancy outcome of participants
timeFrame: At the point of birth of the neonate
measure: Pregnancy outcome of participants
timeFrame: At the point of birth of the neonate
measure: Pregnancy outcome of participants
timeFrame: From date of randomisation up to 7 days after birth of the neonate
measure: Demographic data of participants
timeFrame: On the date of randomisation
measure: Demographic data of participants
timeFrame: On the date of randomisation
measure: Demographic data of participants
timeFrame: On the date of randomisation
measure: Demographic data of participants
timeFrame: On the date of randomisation up to 40 weeks gestation based on the first trimester weight documented in the antenatal record
measure: Demographic data of participants
timeFrame: On the date of randomisation till 40 weeks gestation
measure: Demographic data of participants
timeFrame: On the date of randomisation up to 40 weeks gestation
measure: Demographic data of participants
timeFrame: On the date of randomisation up to 40 weeks gestation
measure: Demographic data of participants
timeFrame: On the date of randomisation up to 40 weeks gestation
measure: Clinical characteristics of participants
timeFrame: On the date of randomisation up to 40 weeks gestation
measure: Clinical characteristics of participants
timeFrame: On the date of randomisation up to 40 weeks gestation
measure: Clinical characteristics of participants
timeFrame: On the date of randomisation up to 40 weeks gestation
measure: Clinical characteristics of participants
timeFrame: At the point of randomisation till 40 weeks gestation
measure: Clinical characteristics of participants
timeFrame: At the point of randomisation till 40 weeks gestation
measure: Clinical characteristics of participants
timeFrame: At the point of randomisation till 40 weeks gestation
measure: Clinical characteristics of participants
timeFrame: At the point of randomisation till 40 weeks gestation
measure: Clinical characteristics of participants
timeFrame: At the point of randomisation till 40 weeks gestation
measure: Clinical characteristics of participants
timeFrame: At the point of randomisation till 40 weeks gestation
Secondary outcomes:
measure: Requirement of treatment in participants
timeFrame: From the date of randomisation up to 40 weeks gestation
measure: Requirement of treatment in participants
timeFrame: From point of randomisation till 40 weeks gestation
measure: Participants' compliance
timeFrame: From point of randomisation till 40 weeks gestation
measure: Participants' satisfaction
timeFrame: From point of randomisation till 40 weeks gestation
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Antenatal clinic, UKM Medical Centre
state: Kuala Lumpur
city: Cheras
country: Malaysia
facility: National University of Malaysia
state: Kuala Lumpur
Study officials:
affiliation: National University of Malaysia
name: Noor Dalila Berohan
role: PRINCIPAL_INVESTIGATOR
affiliation: National University of Malaysia
name: Norasyikin Abd Wahab
role: STUDY_DIRECTOR
affiliation: National University of Malaysia
name: Shuhaila Ahmad
role: STUDY_CHAIR
References: