Search

Severe perineal trauma (SPT) affecting the anal sphincter muscle complex is a serious complication following childbirth, associated with short-term and long-term maternal morbidity. Effective preventive strategies are still scarce. The aim of the Oneplus trial was to test the hypothesis that the presence of a second midwife during the second stage of labour, with the purpose of preventing SPT, would result in fewer injuries affecting the anal sphincter than if attended by one midwife.In this multicentre, randomised, controlled parallel group, unmasked trial done at five obstetric units in Sweden, women were randomly assigned to be assisted by either one or two midwives in late second stage. Nulliparous women and women planning the first vaginal birth after caesarean section who were age 18-47 years were randomly assigned to an intervention when reaching the second stage of labour. Further inclusion criteria were gestational week 37+0, carrying a singleton live fetus in vertex presentation, and proficiency in either Swedish, English, Arabic, or Farsi. Exclusion criteria were a multiple pregnancy, intrauterine fetal demise, a planned caesarean section, or women who were less than 37 weeks pregnant. Randomisation to the intervention group of two midwives or standard care group of one midwife (1:1) was done using a computer-based program and treatment groups were allocated by use of sealed opaque envelopes. All women and midwives were aware of the group assignment, but the statistician from Clinical Studies Forum South, who did the analyses, was masked to group assignment. Midwives were instructed to implement existing prevention models and the second midwife was to assist on instruction of the primary midwife, when asked. Midwives were also instructed to complete case report forms detailing assistance techniques and perineal trauma prevention techniques. The primary outcome was the proportion of women who had SPT, for which odds ratios (ORs) and 95% CIs were calculated, and logistic regression was done to adjust for study site. All analyses were done according to intention to treat. The trial is registered with ClinicalTrials.gov, NCT0377096.Between Dec 10, 2018, and March 21, 2020, 8866 women were assessed for eligibility, and 4264 met the inclusion criteria and agreed to participate. 3776 (88·5%) of 4264 women were randomly assigned to an intervention after reaching the second stage of labour. 1892 women were assigned to collegial assistance (two midwives) during the second stage of labour and 1884 women were assigned to standard care (one midwife). 13 women in each group did not meet the inclusion criteria and were excluded. After further exclusions, 1546 women spontaneously gave birth in the intervention group and 1513 in the standard care group. 1546 women in the intervention group and 1513 in the standard care group were included in the intention-to-treat analysis of the primary outcome. There was a significant reduction in SPT in the intervention group (3·9% [61 of 1546] vs 5·7% [86 of 1513]; adjusted OR 0·69 (0·49-0·97).The presence of two midwives during the active second stage can reduce SPT in women giving birth for the first time.The Swedish Research Council for Health, Working Life and Welfare; Jan Hains Research Foundation; and Skane County Council's Research and Development Foundation.

Objective The ideal implant material for the surgical repair of pelvic organ prolapse in women is yet to be found. This retrospective study aims to evaluate a porcine small intestinal submucosa (SIS) graft (Surgisis™). Study design We reviewed the medical records of women that were operated upon for pelvic organ prolapse using implantation of SIS graft and we examined the short-term complications and recurrence rates. Results A total of 155 surgical procedures were reviewed. SIS graft was placed in the anterior, posterior and middle compartments in 93 (60%), 71 (45.8%) and 13 (8.4%) cases, respectively. At three-month follow-up, 22.6% of anterior graft repairs displayed anatomical recurrence (POP-Q stage ≥ 2), compared to 4.8% of posterior and none of the middle compartment graft repairs. During the three postoperative months, 56% of the women were recorded with complications, mostly urinary retention (19%) and pain (12%). The incidence of grade III complications was 5.3%. Persistent complications at three months were observed in 28% of all cases. Logistic regression analysis showed that previous prolapse surgery at the same compartment was a significant predictor for recurrence of prolapse after SIS graft application, whereas lower age, smoking and longer duration of surgery were significant predictors for the development of complications. Younger women had higher risk of developing pain postoperatively. Conclusion Pain and urinary tract symptoms hold a central position in the complications profile of SIS graft-augmented prolapse surgery. The relatively high recurrence rates do not suggest a clear benefit from SIS graft use.

The purpose of this study was to investigate the urethral pressure pattern during short squeezes in incontinent and healthy women before and after pelvic floor exercise and to correlate the findings with vaginal measurements.Sixty women with urinary incontinence and 28 healthy control subjects all aged 53 to 63 years were subject to urethral pressure measurements and vaginal palpation, pressure and surface electromyography measurements. Measurements were repeated after 4 months of pelvic floor exercise in the incontinent group.The appearance of the urethral pressure curve during a squeeze on a semiquantitative scale from 0 to 4, in the healthy group, was 2.2+/-0.3 and, in the incontinent group, was 1.5+/-0.2 (P.0 5), rising to 2.2+/-0.2 after pelvic floor exercise (P.01). The semiquantitative grading correlated with vaginal measurements.The increase of the urethral pressure in response to short squeeze is reduced significantly in incontinent women compared with healthy women of the same age and parity. A normalization was seen after pelvic floor exercise in the incontinent group.

Objective: To follow the effect of a 4-month pelvic floor exercise (PFE) program in women with naive urinary incontinence with vaginal electromyography (EMG), pressure and palpation and also to compare the initial findings with symptom-free women of the same age. Methods: The pelvic floor function expressed with vaginal EMG, pressure and palpation was measured before, during and after 4 months of PFEs in 60 previously untreated incontinent women, 50 of whom completed the study. The patients' perception of the situation and the amount of leakage were estimated before and after PFE. The incontinent group was compared at baseline and after PFE with 28 healthy controls. All women in this study (age 53–63) were randomly recruited from a major population based study. Results: At baseline, the incontinent women had significant reductions of both vaginal EMG activity and pelvic floor muscle condition as estimated by palpation compared to the healthy group. During training a successive, significant increase was seen in both EMG, pressure and palpation and the values eventually exceeded those of the healthy women. The measures reflecting improvement of pelvic floor function thus showed a consistent and progressive pattern. The degree of improvement was higher in those with initial high values in the muscle function tests than in the women with lower initial EMG values, pressures and findings on palpation. No differences were seen between patients with a history of stress incontinence and patients with an urge component, i.e. urge or mixed incontinence. Sixty-four percent of the women were satisfied and wanted no further treatment. The median leakage at pad-test decreased from 5 (range 0–328) to 1 (range 0–126) g/24h. The correlation between the vaginal and the pad-test measurements was weak. Conclusion: Women with urinary incontinence have a significant reduction of pelvic floor function as estimated with vaginal EMG and palpation as compared to symptom-free controls. A successive normalization of vaginal EMG, pressure and findings at palpation was seen during the 4-month training period. Incontinence of both stress type and with an urge component can be alleviated in most of the women with PFE. These methods might be useful for routine evaluation of the pelvic neuromuscular disorder present in incontinent women.