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

Not Recruiting

Trial ID: NCT01325805


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

Stanford Investigator(s)

Sun Kim, M.D. M.S.
Sun Kim, M.D. M.S.

Associate Professor of Medicine (Endocrinology)


Inclusion Criteria:

   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. 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

   7. Enrollment in another clinical trial (excluding surveys)


behavioral: Structured Weight Loss Program

behavioral: Routine Weight Loss Counseling

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jamie Masie, MD