Efficacy of a Structured Weight Loss Program in Overweight Women With a History of Recurrent Pregnancy Loss

Trial ID or NCT#

NCT01325805

Status

not recruiting iconNOT RECRUITING

Purpose

Overweight and obesity has been associated with a number of adverse pregnancy outcomes in women of reproductive age, including infertility and early pregnancy loss. Recent data suggests that overweight and obese patients are also at increased risk of recurrent pregnancy loss (RPL), a devastating condition that affects 1% of the fertile population. The investigators propose a prospective, randomized controlled trial in which overweight and obese patients with unexplained recurrent pregnancy loss are enrolled in a structured, 6 month, weight loss program or provided routine counseling regarding the importance of weight loss. Pregnancy outcomes will then be followed to assess miscarriage rates. Metabolic outcomes, such as lipid and glucose profiles, will also be evaluated.

Official Title

Pregnancy Outcomes in Overweight and Obese Women With a History of Recurrent Pregnancy Loss Randomized to a Structured Weight Loss Program Versus Routine Weight-Loss Counseling: A Pilot Study

Eligibility Criteria

Ages Eligible for Study: 18 Years to 39 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. 1. Unexplained recurrent pregnancy loss (2 or more prior miscarriages) 2. BMI >=25 kg/m2 3. Prepared to take 3 months ¡®time out¡± from attempting to conceive 4. Ability to attend a one hour initial, then 30 minute follow-up nutrition/monitoring session - once per week for one month, then every other week for 2 months, then once then once per month for 3 months.
Exclusion Criteria:
  1. 1. Age >=40 years 2. Diagnosis of Type 1 or Type 2 Diabetes as defined by a fasting glucose >=126, or 2 hour glucose >=200 by a 75 gram oral glucose challenge 3. Presence of an endocrine condition such as hyperprolactinemia, Cushing¡-s syndrome or untreated thyroid disease (defined as a TSH outside of the laboratory determined normal range) 4. Desire to continue attempts to conceive for the duration of the program 5. History of bariatric surgery 6. Use of over-the-counter or prescribed weight loss medications with the exception of metformin 7. Enrollment in another clinical trial (excluding surveys)
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Investigator(s)

Sun Kim, M.D. M.S.
Sun Kim, M.D. M.S.
Endocrinologist
Associate Professor of Medicine (Endocrinology)

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Contact

Jamie Masie, MD
650-498-7408

View on ClinicalTrials.gov