A new Michigan Medicine clinical trial — now enrolling participants — hopes to determine how weight loss prior to pregnancy affects maternal and fetal health.
A woman’s overall health before conception can impact her pregnancy and the health of her fetus.
“Half of all pregnant women in the United States are overweight or obese, increasing the mother’s risk of pregnancy complications, including gestational diabetes, preeclampsia, fetal anomalies, premature birth, C-section and fetal demise,” says Amy Rothberg, M.D., Ph.D., associate professor of endocrinology at Michigan Medicine.
“The infants of these mothers also carry a lifetime risk of obesity, diabetes and heart disease.”
Now, Rothberg is leading a new clinical trial to investigate what happens when obese women lose weight before conception.
“Evidence proposes that the origins of obesity start at the earliest stages of human development: while still in the womb and during early infancy,” Rothberg says.
“A mother’s nutritional, metabolic and behavioral status, such as pre-pregnancy weight and diet before and during pregnancy, may permanently influence the metabolic, endocrine and immune function of the fetus well into adulthood.”
Details on the clinical trial
The trial, being held at Michigan Medicine over the next five years, is looking to enroll both medically normal weight women (BMI 18-25) and obese women (BMI 30-45), ages 18 to 40, who are interested in becoming pregnant in the next 12 months after their enrollment.
Using Rothberg’s Weight Management Program, obese women will be randomized to either traditional dietary counseling or an aggressive weight loss plan with a target weight loss of 15 percent body weight.
Prior to conception, all participants will undergo testing, such as an oral glucose test to determine if the woman has prediabetes or diabetes, other blood tests and an exercise test. Obese participants will meet with a dietitian at least once prior to becoming pregnant.
Once pregnant, all women will come in once a trimester for a physical exam, ultrasound and labs, with another oral glucose test taking place in the second trimester. All participants will also meet with a dietitian monthly to ensure they are gaining the appropriate amount of weight.
During delivery, several tests and measurements will be recorded from both mother and baby. Study visits will continue after delivery at one, three, six and 12 months with blood samples collected from mom and infant, and length, weight and percentage of growth of the infant also recorded.
Rothberg created the Weight Management Program to identify strategies that will help obese individuals manage their weight over the long term.
“Overweight/obesity are epidemics and prevention is key,” Rothberg says. “Obesity before conception may predispose a new generation to increased risk of obesity and the downstream negative consequences.”
She’s eager to see how the weight loss affects the developing fetus.
“Growth in pregnancy and rate of growth in the first six months of life are predictors of weight in later life,” Rothberg says.
The trial (NIH, NCT03244722) is currently enrolling. To find more information, visit ClinicalTrials.gov or UMHealthResearch.org. To see if you are a candidate, contact Shannon Considine at email@example.com or 734-232-6483.