Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes

Not Applicable

Active, not recruiting

• Conditions: Obesity; Familial; Pregnancy Related

• Registration Number: NCT03244722
• Lead Sponsor: University of Michigan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-8-5
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 352

Inclusion Criteria

Inclusion Criteria:<br><br> - BMI > 30 = 45 for obese participants OR<br><br> - BMI = 25 for healthy body weight participants<br><br> - No known infertility<br><br> - No known risk factors for tubal disease<br><br>Exclusion Criteria:<br><br> - Significant medical co-morbidities (e.g. heart, kidney, liver, autoimmune disease)<br><br> - Significant anemia<br><br> - Cancer other than minor skin cancers<br><br> - Conditions that would complicate pregnancy<br><br> - Recent use of anti-obesity drugs or appetite suppressants<br><br> - Previous bariatric surgery<br><br> - Endometriosis AFS (American Fertility Society classification class III or IV)<br><br> - Progesterone > 10 IU/ml<br><br> - Current pregnancy<br><br> - Use of sperm donor

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preconception weight loss;Metabolome and inflammatory markers;Offspring body fat mass;Cord blood related to neonate outcomes;DNA methylation

Secondary Outcome Measures

Name	Time	Method
Participant waist circumference in centimeters;Fetal growth will be assessed by ultrasound;Infant length and weight;Metabolite levels