To assess the acceptability and feasibility of using a specially designed irregular silicone hexagonal-shaped vaginal pessary [Conservative Pelvic Organ Pessary (C-POP)] in up to 10 postpartum women with high risk factors for pelvic organ prolapse for 12-weeks. We hypothesize that the majority of women fitted with the C-POP will use it for the entire study period.

Consecutive primigravid women who underwent either forceps or vacuum-assisted vaginal deliveries for >= term singletons with birthweights of >=3500g were invited to participate in this IRB-approved interventional observation pilot study. Women who experienced 4th degree anal sphincter tears were ineligible. Eligible women presented for their initial study visit 3-weeks postpartum, where they completed a clinical evaluation, questionnaires, and a physical examination. At this visit, women were then fitted with an appropriately sized novel flexible hexagonal medical grade silicone vaginal pessary determined on a ‘best-fit’ basis by the inserting clinician. The C-POP (Gynaecologic Pty Ltd., Melbourne, Vic, Australia) is available in 5 different sizes from XSmall [60mm(l) x 65mm(w)], Small [65mm(l) x 70mm(w)], Medium [70mm(l) x 75mm(w)], Large [75mm(l) x 80mm(w)] and XLarge [80mm(l) x 85mm(w)].  The participants were trained to remove, clean, and replace the pessary during the 12-week study. Women were given information about potential pessary problems and  management plans. Pessary diaries were provided to document symptoms and duration of pessary use. Women were allowed to have an overnight break once a week if they wished, however, they were advised not to have the pessary out for >24hrs in 1 week. Women could remove the pessary prior to sexual intercourse. At two weeks after the initial fitting, women were reviewed and answered basic questionnaires. At the final 12-week post pessary insertion visit, final questionnaires and clinical examinations including a prolapse assessment [pelvic organ prolapse quantification – POP-Q)] were completed. This study is currently ongoing.

A total of 43 eligible primiparous postpartum women were invited to participate, with three women (7%) officially enrolled. The first officially enrolled women has been lost to follow-up (Enrolee 1). The mean age of all the women is 32.0 (+/- 4.1) years old, and that of the enrolled group is 34.0 (+/- 1.7) years old. Average birth weights of the cohort was 3.9 (+/- 0.3) kg and that of the enrolled is 3.8 (+/- 0.3) kg. Mean estimated blood loss at delivery was 778.1 (+/- 472.7) mls for the cohort and 483.3 (+/- 284.3) mls for the enrolees. Twenty-five women delivered with Neville Barnes forceps (NBFD) and 18 women had vacuum assisted vaginal deliveries (VAVD). Enrolee 1 underwent a VAVD and the other two participants who completed study enrolment underwent NBFDs. Nearly all (95.3%) of the total cohort of women had a right mediolateral episiotomy including all of the enrolees. None of the women had a 3rd degree or greater anal sphincter tear. Approximately 30% (13/43) of the cohort experienced other delivery complications such as postpartum haemorrhage, or shoulder dystocia and one enrolee experienced elevated blood pressures. 
During recruitment, one woman declined participation on the postpartum ward when approached as she did not want a foreign body inserted. The remaining 42 women agreed to be re-contacted in 2 weeks’ time to discuss possible participation in the study. Two weeks later, all the women were contacted and 29 immediately declined. Nine women never answered the recruitment telephone calls. Four women agreed to participate in the study, but one later declined. The main reasons for declining to participate included concerns regarding perineal wound healing, fears of infection, and the unwillingness to attend appointments with a busy newborn. Enrolee 1 entered the study as she was “feeling pressure down below” but withdrew from the study on day 3 post C-POP insertion after experiencing an episode of vaginal bleeding which resolved after she removed the medium sized pessary herself. She was ultimately satisfied with the symptom resolution but became uncontactable thereafter.  
At the initial visit, all official enrolees were breastfeeding. Enrolees 1 and 2 had normal vaginal examinations while enrolee 3 had vaginal atrophy. Enrolees 1 and 2 had visible sutures while enrolee 2 had a slight separation of wound edges.  All tissue edges were noted to be clean and healthy in all enrolees. There were no concerning vaginal findings, therefore all enrolees were fitted with medium, small, and small hexagonal pessaries respectively. At the second visit, enrolee 2 had removed the pessary herself for <24 hrs per week and enrolee 3 decided to keep the pessary in situ and not remove it until study conclusion. No participants reported bothersome vaginal discharge at this point. At the final visit enrolee 2 had removed the pessary for 2 hours at week 10 and enrolee 3 experienced non-bothersome vaginal discharge toward the last study week. Enrolee 2 experienced mild urinary incontinence and constipation with some difficulty emptying her bladder noted between week 8 and 10. Enrolee 2’s final POP-Q is pending but reports no prolapse symptoms while enrolee 3 has stage 0 prolapse on final exam. At the conclusion of the study, both remaining enrolees were ‘extremely satisfied’, would be happy to reconsider it if knowing using it could help prevent pelvic organ prolapse and they would recommend it to a friend.

The use of a vaginal pessary in the postpartum period has the potential to be a secondary prevention intervention against the development of pelvic organ prolapse. The postpartum woman encompasses a group of individuals who are crucial to study despite historically being excluded from treatment/intervention clinical trials. Our study has revealed and identified key factors in acceptability/feasibility in studying these important groups of women while simultaneously providing early preliminary evidence addressing the very early prevention of pelvic organ prolapse in at risk women (birthweight - 3500g and delivery method – forceps/vacuum) after vaginal delivery. 
Dogma currently exists surrounding the current shapes, sizes and materials used for pessaries, highlighting an opportunity for innovation in this space. The idea behind a novel flexible silicone hexagonal shaped pessary is indicative of that innovation and needs to be further studied. 
This study has revealed a 3/43 (7%) rate of enrolment, identifying a small but equally important group of women who need care. Further, amongst the enrolees, we have shown that postpartum women can self-manage a pessary even in the presence of vaginal bleeding. Finally, the low symptom profile of an enrolee who retained the pessary for 12-weeks without removing it is encouraging.

The high rate of pelvic organ prolapse highlights the need to develop secondary preventative strategies. Using a vaginal pessary in the early postpartum period may reduce the prevalence of pelvic organ prolapse in at risk women. This ongoing pilot study is an important first step in establishing the acceptability and tolerability of wearing a pessary postpartum before commencing a larger comparative study to assess the effectiveness and safety of using a pessary postpartum aimed at reducing the prevalence of pelvic organ prolapse.