Status:Active, not recruiting
Keywords:Pelvic Organ Support , Currently Pregnant , Pelvic Floor
Specialty:Urogyn and Pelvic Reconstructive Surgery
This is an ancillary study to nuMoM2b, an IRB approved study that is enrolling pregnant women in the first trimester and then following them until delivery. As part of the nuMoM2b study, women undergo speculum exams for collection of vaginal fluid and complete a battery of questions. The primary aim of our ancillary study is to estimate and compare the prevalence, incidence, and resolution of pelvic organ prolapse at 3 time points (1st and 3rd pregnancy trimesters and 12 months postpartum) in 3 cohorts of women: 1) vaginal delivery 2) Cesarean delivery after the onset of active labor, and 3) Cesarean delivery prior to the onset of active labor. In addition, the study aims to define maternal tissue adaptations in pregnancy that afford maximal distention of the vagina at the time of delivery (this aim will be done by analyzing vaginal fluid for collagenases and other factors).
Activities that will take place as part of our study includes: 2 study visits at the same time as the nuMoM2b visit during the 1st trimester and 3rd trimester of pregnancy, 1 telephone visit 6 mo postpartum and 1 in-person visit 12 mo postpartum. The latter 2 visits are done only for our study. At the in-person visits, at the time of the nuMoM speculum exams, we will collect 2 vaginal swabs, clean catch urine, and will do a specialized vaginal exam to quantify pelvic organ support (called the POP-Q exam). Women will be given a questionnaire about pelvic floor symptoms to complete at home either on paper or on line (the IT core of the CTSC is creating a RedCap survey instrument for us which will be identical to the paper version in this application). At the 6-month telephone visit, we will touch base, get a correct mailing address or email address and send the woman 6-month surveys to complete. At the 12 -month in-person visit, we will do the same exam described above and the same questionnaire as at the 6 month visit. We will also abstract data from the nuMoM2b database for additional relevant information to our study (delivery details, sleep, food frequency and physical activity questionnaires; these are all approved under the nuMoM2b study). At 6 mo and 12 mo postpartum, in addition to the symptoms survey attached with this application, women will also be asked to complete a sleep questionnaire, an activity survey, and a food frequency survey (they do these during pregnancy for the nuMoM2b study) and a supplementary questionnaire that includes changes in their medical or surgical history, menstrual history, and breastfeeding status. In this initial application, we are including the final versions of the 1st trimester and 3rd trimester instruments but will submit the 6-month and 12-month instrument in a final version as an amendment later.
Principle Investigator: Ingrid Nygaard
Principle Department: Urogynecology
Primiparous women 18 and older enrolled in nuMoM2b study.