Contraceptive counseling for women undergoing medical and surgical weight loss: A feasibility study
Contraception
Awarded 2013
Complex Family Planning Fellowship Research
Amy Paris, MD
Boston Medical Center
$29,363

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.
 

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