Contraceptive counseling for women undergoing medical and surgical weight loss: A feasibility study
Awarded 2013
Complex Family Planning Fellowship Research
Amy Paris, MD
Boston Medical Center

Weight loss can markedly improve fertility, and women undergoing weight loss are at risk for unintended pregnancy.  Women are counseled to avoid pregnancy within 12-18 months of bariatric surgery and/or while taking teratogenic weight loss medications.  
We hypothesized that an on-site contraceptive counseling intervention tailored to the specific needs of these women may help them avoid unwanted pregnancies.   The purpose of this study was to determine whether a randomized trial of such an intervention
would be feasible, and to develop the counseling and referral process that would be used in such a study.
50 women taking part in a medical or surgical weight loss program at our academic tertiary care hospital were enrolled in this randomized feasibility study.  The intervention group underwent a structured contraceptive counseling session tailored to the woman’s medical history and weight loss plan, followed by referral, if desired, for same-day, on-site provision of her chosen contraecptive method. The control group received routine care. The primary outcome was feasibility, defined as 80% of eligible participants willing to be randomized, enrollment completed in three months, and the ability to obtain complete follow-up data on 80% of participants.  Secondary outcomes were the proportion of women who chose, started, and continued a method; pregnancies; and satisfaction with the counseling intervention.  Secondary outcomes were measured via telephone survey at one and four months of follow-up. 
We found that the majority of women we approached (n=443) were willing to be screened for the study (n=386, 87%), and of those screened, all (n=50, 100%) of eligible subjects agreed to be randomized.  However, enrollement was not able to be completed within three months, mostly due to a higher-than-expected rate of exclusion (n= 336, 87%).  The most common reason for exclusion was already using effective contraception (n=169, 44%).  We were able to meet follow-up goals for 1 month (n=42, 84%) but not four months (n=22, 44%), largely because the study ran out of time prior to completion of follow-up.  
The study satisfied one of three feasibility endpoints.  The greatest obstacle to enrollment was the unexpectedly high proportion of women meeting exclusion criteria. For a larger trial to be feasible, it would need to draw from a larger pool of potential participants, perhaps by involving additional centers; budget for a longer recruitment period; and/or be able to enroll non-English speaking participants.