Feasibility of a longitudinal study of women anticipating first pregnancy and assessed by multiple pelvic exams: recruitment and retention challenges

Abstract

Objective: To better understand the relationship between childbirth and pelvic floor disorders the ideal study design would begin with data collection prior to but close in time to first pregnancy and follow participants through postpartum. We conducted a feasibility study to determine the following: a) whether women desiring to get pregnant would agree to pre-pregnancy data collection including a one-time urethral catheter measure and repeat pelvic exams to ascertain a baseline within 6 months of pregnancy; b) effectiveness of various recruitment and retention methods, c) number achieving pregnancy, and then d) number expressing willingness to continue follow-up through pregnancy and postpartum.

Methods: Advertising included newspaper ads, targeted emails and flyers. Post-enrollment, four data collection visits were scheduled and occurred every 6 months or until pregnant. If pregnancy occurred, women were asked to indicate their willingness to continue assessments.

Results: The most successful advertising strategy for both recruitment and retention was local newspaper ads. Ninety-four women inquired about the study, 30 enrolled. Post-baseline retention was 23 women at 6 months, 17 at 12 months, and 13 at 18 months. Nine of the 30 women achieved pregnancy; two remained eligible and willing to participate through pregnancy and postpartum.

Conclusions: This study provides data on feasibility of recruiting women to establish near-pregnancy clinical baseline measures that include pelvic exams. Close to 30% reached pregnancy within 2 years of study start and within 6 months of most recent pelvic exam measure. Of those who became pregnant, 22% expressed willingness to continue follow-up into the childbearing year.

Figure 1

Pregnant Participant Attrition