Screening for gestational diabetes: a randomised clinical trial of two universal methods

Not Applicable

Completed

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

• Registration Number: ISRCTN15700608
• Lead Sponsor: Our Lady of Lourdes Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-05-23
• Study Start: 2019-10-07
• Last Update Posted: 29 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

All pregnant women aged 18-45

Exclusion Criteria

1. Previous diagnosis of diabetes
2. Use of insulin
3. HbA1C>6.5%
4. Inability to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal blood glycated haemoglobin level (HbA1c) at 16 and 36 weeks gestation

Secondary Outcome Measures

Name	Time	Method
<br> 1. Maternal quality of life measured using PES scale, DASS, PSSS, EQ5D<br> 2. Cost (attendance for GDM screening, attendance for prenatal visits, number of prenatal visits)<br> 3. Fetal and neonatal parameters (large-for-gestational-age, birth weight> 4 kg, shoulder dystocia, bone fracture, nerve palsy, stillbirth, perinatal death, hypoglycaemia, weight, jaundice, admission to the special care baby unit)<br> 4. Maternal and delivery parameters (gestational hypertension, pre-eclampsia, eclampsia, gestational diabetes, hypoglycaemia, HbA1c >5.6%, receipt of nutritional counselling, use of glucose-lowering therapies, blood pressure, weight gain, induction of labour, caesarean delivery)<br>