Comparison of the effect of antenatal dexamethasone and betamethasone on blood sugar control in diet-controlled gestational diabetics

Not Applicable

• Conditions: Gestational diabetes mellitus; Pregnancy and Childbirth; Diabetes mellitus arising in pregnancy

• Registration Number: ISRCTN11357822
• Lead Sponsor: niversity of Malaya Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-21
• Last Update Posted: 16 February 2021
• Study Completion: 2023-12-31

Recruitment & Eligibility

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

Inclusion Criteria

1. Gestational diabetes adequately controlled by lifestyle modification (gestational diabetes mellitus was defined as 75 g oral glucose tolerance test (OGTT) fasting blood glucose =5.1 mmol/l and/or 2 hours post-prandial glucose =7.8 mmol/l in pregnant women without prior history of hyperglycemia based on Malaysian National Clinical Practice Guideline diagnostic thresholds
2. Gestational age 24-37 weeks
3. Age =18 years old
4. Singleton pregnancy

Exclusion Criteria

1. Patients on anti-glycemic agent
2. Baseline (at recruitment) capillary blood glucose level =11 mmol/l
3. Active labor or having a high likelihood to deliver within the next 24 hours
4. Suspected chorioamnionitis, suspected maternal or fetal infection
5. On beta-sympathomimetic agent tocolysis
6. On oral intake restriction in anticipation of imminent (within next 24 hours) Cesarean birth

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Hyperglycemia episodes in the first 24 hours following administration of antenatal corticosteroids, measured by point of care capillary blood glucose monitoring system at six points (pre and post breakfast, lunch and dinner) . Hyperglycemia is defined as pre-meal blood glucose level of more than 5.3 mmol/l and 2 hours postprandial/meal blood glucose of more than 6.7 mmol/l<br> 2. Hyperglycemia episodes in the second 24 hours following administration of antenatal corticosteroids, by measuring point of care capillary blood glucose at points 7-12<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Need for an anti-glycaemic agent (metformin or insulin), as indicated by capillary blood glucose levels for the duration of monitoring<br> 2. Maternal outcomes assessed by reviewing patient’s notes after delivery:<br> 2.1. Mode of delivery<br> 2.2. Estimated blood loss during delivery<br> 3. Neonatal outcome assessed by reviewing patient’s and newborn’s notes after delivery:<br> 3.1. Birth weight<br> 3.2. Umbilical cord arterial pH at birth<br> 3.3. Apgar score at first and fifth minute of life<br> 3.4. Neonatal admission to special care nursery or neonatal intensive care<br> 4. Patient satisfaction with their allocated antenatal dexamethasone or betamethasone regime measured using numerical rating score (NRS) score after 3 days of monitoring or as soon as possible after delivery if it occurs sooner<br>