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Objectives To investigate prolapse symptoms and objectively measured pelvic organ prolapse, 12 years after childbirth, and association with delivery mode history.Design Twelve-year longitudinal study.Setting Maternity units in Aberdeen, Birmingham and Dunedin.Population Women dwelling in the community.Methods Data from women were collected 12 years after an index birth and women were invited for examination. Logistic regression investigated associations between risk factors and prolapse symptoms and signs.Main outcome measures Prolapse symptom score (POP-SS); objectively measured prolapse (POP-Q).Results Of 7725 continuing women, 3763 (49%) returned questionnaires at 12 years. The median POP-SS score was 2 (IQR 0-4). One or more forceps deliveries (OR 1.20, 95% CI 1.04-1.38) and a body mass index (BMI) over 25 were associated with higher (worse) POP-SS scores, but age over 25 years at first delivery was associated with lower (better) scores. There was no protective effect if all deliveries were by caesarean section (OR 0.84, 95% CI 0.69-1.02). Objective prolapse was found in 182/762 (24%) women. Women aged over 30 years when having their first baby and parity were significantly associated with prolapse. Compared with women whose births were all spontaneous vaginal deliveries, women who had all births by caesarean section were the least likely to have prolapse (OR 0.11, 95% CI 0.03-0.38), and there was a reduced risk after forceps or a mixture of spontaneous vaginal delivery and caesarean section.Conclusions These findings are at odds with each other, suggesting that prolapse symptoms and objective prolapse may not be in concordance, or are associated with different antecedent factors. Further follow-up is planned.

BackgroundNo treatments are currently available that slow, stop, or reverse disease progression in established multiple sclerosis (MS). The Mesenchymal Stem Cells in Multiple Sclerosis (MSCIMS) trial tests the safety and feasibility of treatment with a candidate cell-based therapy, and will inform the wider challenge of designing early phase clinical trials to evaluate putative neuroprotective therapies in progressive MS. Illustrated by the MSCIMS trial protocol, we describe a novel methodology based on detailed assessment of the anterior visual pathway as a model of wider disease processes - the "sentinel lesion approach".Methods/designMSCIMS is a phase IIA study of autologous mesenchymal stem cells (MSCs) in secondary progressive MS. A pre-test : post-test design is used with healthy controls providing normative data for inter-session variability. Complementary eligibility criteria and outcomes are used to select participants with disease affecting the anterior visual pathway.ResultsTen participants with MS and eight healthy controls were recruited between October 2008 and March 2009. Mesenchymal stem cells were successfully isolated, expanded and characterised in vitro for all participants in the treatment arm.ConclusionsIn addition to determining the safety and feasibility of the intervention and informing design of future studies to address efficacy, MSCIMS adopts a novel strategy for testing neuroprotective agents in MS - the sentinel lesion approach - serving as proof of principle for its future wider applicability.Trial registrationClinicalTrials.gov (NCT00395200).

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