Pregnancy Outcomes after Pre-pregnancy weight loss in obese women (POP Study)

Not Applicable

Active, not recruiting

• Conditions: Obesity; Pre-pregnancy weight loss; Diet and Nutrition - Obesity; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12614001160628
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 164

Inclusion Criteria

Planning pregnancy in the next 6 months
BMI equal or greater than 30 and equal or less than 55kg/m2
Living in Victoria Australia

Exclusion Criteria

Type 2 Diabetes
Type 1 Diabetes
Discretion of investigator
Physical or psychiatric illness that would preclude the use of Optifast
Currently pregnant or lactating
Currently undergoing reproductive technology treatment
Irreversible infertility
BMI <30kg/m2 or >55kg/m2
Age <18 years old or >38 years old
Not living in Victoria Australia
Not planning pregnancy in the next 6-12 months (regardless of the method of conception)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In obese (BMI >30kg/m2) non-diabetic women, does substantial pre-conception weight loss (10-15% body weight) result in a =/>10% reduction in maternal fasting plasma glucose (in mmol/L) at 26-28 weeks gestation when compared with maternal fasting plasma glucose (in mmol/L)from women who achieve modest pre-conception body weight (<3% body weight). [Fasting maternal glucose at 26-28 weeks gestation will be used as the primary outcome. Therefore, the primary outcome timepoint will be 26-28 weeks gestation.]