Probiotics in Pregnancy Study (ProP Study)

Not Applicable

Completed

• Conditions: Pregnancy, obesity, gestational diabetes mellitus; Pregnancy and Childbirth; Diabetes mellitus in pregnancy

• Registration Number: ISRCTN97241163
• Lead Sponsor: ational Maternity Hospital (Ireland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-09
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

Current inclusion criteria as of 30/07/2012:
Part A - prevention of GDM:
1. BMI between 30.0 and 39.9 Kg/m2
2. Gestational age = 22 weeks
3. Age 18 - 45 years
4. Adequate understanding of the English language

Part B - treatment of GDM:
1. BMI in any category
2. Gestational age <36 weeks
3. New diagnosis of GDM or impaired glucose tolerance (IGT)
4. Age 18 - 45 years
5. Adequate understanding of the English language

Previous inclusion criteria until 30/07/2012:
Part B - treatment of GDM:
3. New diagnosis of GDM (not in previous pregnancy)

Exclusion Criteria

Part A - prevention of GDM:
1. BMI <30.0 or >39.9 Kg/m2
2. Age <18 or >45 years
3. Gestational age >22 weeks
4. Foetal anomaly
5. Twin pregnancy
6. Inadequate understanding of English
7. Diabetes - type 1, type 2, newly diagnosed GDM or previous GDM

Part B - treatment of GDM:
Age <18 or >45 years
1. Gestational age >36 weeks
2. Foetal anomaly
3. Twin pregnancy
4. Inadequate understanding of English
5. GDM diagnosis in previous pregnancy or type 1 or 2 diabetes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obese pregnant mothers (Part A): <br>Difference between the control and probiotic groups in fasting blood glucose<br><br>Gestational diabetes (Part B):<br>Difference between the control and probiotic groups in fasting blood glucose

Secondary Outcome Measures

Name	Time	Method
Part A - differences between the 2 groups: <br>1. Incidence of gestational diabetes<br>2. Neonatal anthropometry<br><br>Part B are the following differences between the 2 groups: <br>1. Requirement for insulin<br>2. Gestation at commencement of insulin and amount of insulin required<br>3. Neonatal anthropometry