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Randomized trial of cesarean vs vaginal delivery for effects on the pelvic floor in squirrel monkeys.

ABSTRACT: BACKGROUND:Vaginal delivery is a risk factor in pelvic floor disorders. We previously described changes in the pelvic floor associated with pregnancy and parturition in the squirrel monkey, a species with a humanlike pattern of spontaneous age- and parity-associated pelvic organ prolapse. OBJECTIVE:The potential to prevent or diminish these changes with scheduled cesarean delivery (CD) has not been evaluated. In a randomized, controlled trial, we compared female squirrel monkeys undergoing spontaneous vaginal delivery with those undergoing scheduled primary CD for pelvic floor muscle volumes, muscle contrast changes, and dynamic effects on bladder neck position. STUDY DESIGN:Levator ani, obturator internus, and coccygeus (COC) muscle volumes and contrast uptake were assessed by magnetic resonance imaging in 20 nulliparous females examined prior to pregnancy, a few days after delivery, and 3 months postpartum. The position of bladder neck relative to bony reference line also was assessed with abdominal pressure using dynamic magnetic resonance imaging. RESULTS:Baseline measurements of 10 females randomly assigned to scheduled primary CD were not different from those of 10 females assigned to spontaneous vaginal delivery. Levator ani and obturator internus muscle volumes did not differ between groups, while volumes were reduced (P < .05) in the observation immediately after pregnancy. The COC muscles increased (P < .05) immediately after delivery for females in the spontaneous vaginal delivery group, but not for females in the scheduled CD group. Position of the bladder neck descended (P < .05) by 3 months postpartum in both groups. CONCLUSION:Scheduled CD diminishes changes in COC muscle volume and contrast reported to be associated with spontaneous vaginal delivery in squirrel monkeys. However, pelvic support of the bladder was not protected by this intervention suggesting that effects of pregnancy and delivery are not uniformly prevented by this procedure.

SUBMITTER: Lindo FM

PROVIDER: S-EPMC5134251 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Randomized trial of cesarean vs vaginal delivery for effects on the pelvic floor in squirrel monkeys.

Lindo Fiona M FM Carr Emily S ES Reyes Michelle M Gendron Jilene M JM Ruiz Julio C JC Parks Virginia L VL Kuehl Thomas J TJ Larsen Wilma I WI

American journal of obstetrics and gynecology 20150912 5

<h4>Background</h4>Vaginal delivery is a risk factor in pelvic floor disorders. We previously described changes in the pelvic floor associated with pregnancy and parturition in the squirrel monkey, a species with a humanlike pattern of spontaneous age- and parity-associated pelvic organ prolapse.<h4>Objective</h4>The potential to prevent or diminish these changes with scheduled cesarean delivery (CD) has not been evaluated. In a randomized, controlled trial, we compared female squirrel monkeys u ...[more]

PMID: 26366665

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Project description:BACKGROUND:Twin birth is associated with a higher risk of adverse perinatal outcomes than singleton birth. It is unclear whether planned cesarean section results in a lower risk of adverse outcomes than planned vaginal delivery in twin pregnancy. METHODS:We randomly assigned women between 32 weeks 0 days and 38 weeks 6 days of gestation with twin pregnancy and with the first twin in the cephalic presentation to planned cesarean section or planned vaginal delivery with cesarean only if indicated. Elective delivery was planned between 37 weeks 5 days and 38 weeks 6 days of gestation. The primary outcome was a composite of fetal or neonatal death or serious neonatal morbidity, with the fetus or infant as the unit of analysis for the statistical comparison. RESULTS:A total of 1398 women (2795 fetuses) were randomly assigned to planned cesarean delivery and 1406 women (2812 fetuses) to planned vaginal delivery. The rate of cesarean delivery was 90.7% in the planned-cesarean-delivery group and 43.8% in the planned-vaginal-delivery group. Women in the planned-cesarean-delivery group delivered earlier than did those in the planned-vaginal-delivery group (mean number of days from randomization to delivery, 12.4 vs. 13.3; P=0.04). There was no significant difference in the composite primary outcome between the planned-cesarean-delivery group and the planned-vaginal-delivery group (2.2% and 1.9%, respectively; odds ratio with planned cesarean delivery, 1.16; 95% confidence interval, 0.77 to 1.74; P=0.49). CONCLUSIONS:In twin pregnancy between 32 weeks 0 days and 38 weeks 6 days of gestation, with the first twin in the cephalic presentation, planned cesarean delivery did not significantly decrease or increase the risk of fetal or neonatal death or serious neonatal morbidity, as compared with planned vaginal delivery. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00187369; Current Controlled Trials number, ISRCTN74420086.).

Project description:ObjectiveTo evaluate whether there is a differential benefit of planned Cesarean delivery (CD) over planned vaginal delivery (VD) in women with a twin pregnancy and the first twin in cephalic presentation, depending on prespecified baseline maternal and pregnancy characteristics, and/or gestational age (GA) at delivery.MethodsThis was a secondary analysis of the Twin Birth Study, which included 2804 women with a twin pregnancy and the first twin (Twin A) in cephalic presentation between 32 + 0 and 38 + 6 weeks' gestation at 106 centers in 25 countries. Women were assigned randomly to either planned CD or planned VD. The main outcome measure was composite adverse perinatal outcome, defined as the occurrence of perinatal mortality or serious neonatal morbidity in at least one twin. The baseline maternal and pregnancy characteristics (markers) considered were maternal age, parity, history of CD, use of antenatal corticosteroids, estimated fetal weight (EFW) of Twin A, EFW of Twin B, > 25% difference in EFW between the twins, presentation of Twin B, chorionicity on ultrasound, method of conception, complications of pregnancy, ruptured membranes at randomization and GA at randomization. Separate logistic regression models were developed for each marker in order to model composite adverse perinatal outcome as a function of the specific marker, planned delivery mode and the interaction between these two terms. In addition, multivariable logistic regression analysis with backward variable elimination was performed separately in each arm of the trial. The association between planned mode of delivery and composite adverse perinatal outcome, according to GA at delivery, was assessed using logistic regression analysis.ResultsOf the 2804 women initially randomized, 1391 were included in each study arm. None of the studied baseline markers was associated with a differential benefit of planned CD over planned VD in the rate of composite adverse perinatal outcome. GA at delivery was associated differentially with composite adverse perinatal outcome in the treatment arms (P for interaction < 0.001). Among pregnancies delivered at 32 + 0 to 36 + 6 weeks, there was a trend towards a lower rate of composite adverse perinatal outcome in those in the planned-VD group compared with those in planned-CD group (29 (2.2%) vs 48 (3.6%) cases; odds ratio (OR) 0.62 (95% CI, 0.37-1.03)). In pregnancies delivered at or after 37 + 0 weeks, planned VD was associated with a significantly higher rate of composite adverse perinatal outcome, as compared with planned CD (23 (1.5%) vs 10 (0.7%) cases; OR, 2.25 (95% CI, 1.06-4.77)).ConclusionThe perinatal outcome of twin pregnancies with the first twin in cephalic presentation may differ depending on GA at delivery and planned mode of delivery. At 32-37 weeks, planned VD seems to be favorable, while, from around 37 weeks onwards, planned CD might be safer. The absolute risks of adverse perinatal outcomes at term are low and must be weighed against the increased maternal risks associated with planned CD. © 2019 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Project description:BackgroundThere is a risk of pelvic floor dysfunction (PFD) from baby delivery. Many clinical guidelines recommend pelvic floor muscle training (PFMT) as the conservative treatment for PFD because pelvic floor muscles (PFMs) play a crucial role in development of PFD. However, there is disagreement about the method and intensity of PFM training and the relevant measurements. To pilot the study in PFM training, we designed a Pelvic Floor Workout (PEFLOW) for women to train their pelvic through entire body exercises, and we planned a trial to evaluate its effectiveness through comparing the outcomes from a group of postpartum women who perform PELFLOW at home under professional guidance online with the control group.Methods/designThe randomized controlled trial was projected to be conducted from November 2021 to March 2023. A total of 260 postpartum women would be recruited from the obstetrics departments of the study hospital and women would be eligible for participation randomized into experimental or control groups (EG/CG) if their PFM strength are scaled by less than Modified Oxford grading Scale (MOS) to be less than grade 3. Women in EG would perform a 12-week PEFLOW online under the supervision and guidance of a physiotherapist, while women in CG would have no interventions. Assessments would be conducted at enrollment, post intervention (for EG) or 18th to 24th week postpartum (for CG), and 1 year postpartum. Assessment would be performed in terms of pelvic floor symptoms, including MOS, cough stress test, urinary leakage symptoms, pelvic organ prolapse quantitation (POP-Q), and vaginal relaxation, clinic examinations including Pelvic floor electrophysiological test, Pelvic floor ultrasound and Spine X-ray, overall body test including trunk endurance test, handgrip test, body composition test, and questionnaires including International Physical Activity Questionnaire Score-Short Form(IPAQ-SF), Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20), Pelvic Floor Impact Questionnaire-7 (PFIQ-7), the 6-item Female Sexual Function Index (FSFI-6), and the Pittsburgh Sleep Quality Index (PSQI). Primary analysis will be performed to test our main hypothesis that PEFLOW is effective with respect to strengthen PFM strength.DiscussionThis trial will demonstrate that pelvic floor-care is accessible to most women and clinical practice on PFD may change relevantly should this study find that Online PEFLOW approach is effective to improve PFMs.Trial registrationClinicalTrials.gov, NCT05218239.

Project description:ImportanceUrinary incontinence is one of the most prevalent health concerns experienced by older women (aged ≥60 years). Individual pelvic floor muscle training (PFMT) is the recommended first-line treatment for stress or mixed urinary incontinence in women, but human and financial resources limit its delivery. Whether group-based PFMT performs as well as individual PFMT in this population remains unclear.ObjectiveTo assess the efficacy of group-based PFMT relative to individual PFMT for urinary incontinence in older women.Design, setting, and participantsThe Group Rehabilitation or Individual Physiotherapy (GROUP) study is a single-blind, randomized, noninferiority trial conducted in 2 Canadian research centers, from July 1, 2012, to June 2, 2018. A total of 362 community-dwelling women aged 60 years or older with symptoms of stress or mixed urinary incontinence were enrolled.InterventionsAfter an individual session conducted to learn how to contract pelvic floor muscles, participants completed 12-week PFMT as part of a group of 8 women (n = 178) or in individual sessions (n = 184).Main outcomes and measuresThe primary outcome measure was the percentage reduction in urinary incontinence episodes at 1 year, as reported in a 7-day bladder diary and relative to pretreatment baseline. Secondary outcomes included lower urinary tract-related signs, symptoms, and quality of life immediately following treatment and at 1 year. Per-protocol analysis was used.ResultsAmong 362 women who were randomized (mean [SD] age, 67.9 [5.8] years), 319 women (88%) completed the 1-year follow-up and were included in the per-protocol analysis. Median percentage reduction in urinary incontinence episodes was 70% (95% CI, 44%-89%) in individual PFMT compared with 74% (95% CI, 46%-86%) in group-based PFMT. The upper boundary of the 95% CI for the difference in the percentage reduction in urinary incontinence episodes at 1 year was lower than the prespecified margin for noninferiority of 10% (difference, 4%; 95% CI, -10% to 7%; P = .58), confirming noninferiority. Individual PFMT and group-based PFMT had similar effectiveness for all secondary outcomes at 1 year. Adverse events were minor and uncommon.Conclusions and relevanceResults of the GROUP study suggest that group-based PFMT is not inferior to the recommended individual PFMT for the treatment of stress and mixed urinary incontinence in older women. Widespread use in clinical practice may help increase continence-care affordability and treatment availability.Trial registrationClinicalTrials.gov Identifier: NCT02039830.

Project description:ObjectiveThe study aimed to evaluate the contributions of levator ani muscle (LAM) injury, vesical neck movement, urethral length and mobility, and urethral sphincter dysfunction observed on magnetic resonance imaging (MRI) towards stress urinary incontinence (SUI) after vaginal delivery.Materials and methodsFifty primiparous women after 6 months of delivery (15 with SUI and 35 without) and 35 nulliparous as continent controls underwent MRI at rest and Valsalva maneuver. A published levator ani scoring system was used to characterize morphological changes of LAM. The severity of the injury was divided into three categories as none, minor, and major. A series of common parameters including levator plate angle, iliococcygeal angle, and levator hiatus were used to describe the functional conditions of LAM. Urethral mobility was defined based on the rotation of the urethra between Valsalva and rest status. Vesical neck movement was evaluated by its distance to the pubococcygeal line. Urethral sphincter dysfunction was defined as the widening of the proximal urethra and/or funneling at the urethrovesical junction during Valsalva.ResultsPrimiparous incontinent (PI) women had additional major levator ani defects (33.3% vs. 17.1%) while less minor defects (0.7% vs. 31.4%) than primiparous continent (PC) women. Vesical neck downward movement in PI women was more obvious than PC women (28.5 mm vs. 24.2 mm, p = 0.006). Urethral mobility was more active in primiparous women than in nulliparous continent controls (57.4 vs. 52.4), whereas no difference was observed on urethral mobility in the primiparous group (p = 0.25). Urethral sphincter dysfunction and funneling were present in 80% of PI women versus 22.9% in PC women (p < 0.001).ConclusionThe MRI findings revealed that de novo SUI was associated with major LAM injury, vesical neck downward movement as well as urethral sphincter dysfunction. Vesical neck funneling on sagittal images can be treated as a valuable predictor for SUI. The intervention for the PI should focus on the elevation of vesical neck, rehabilitation of LAM as well as recovery of the urethral sphincter muscle.

Project description:Background: Pregnancy and high-impact activity are considered as risk factors for pelvic floor dysfunctions, including urinary incontinence. Aim: To investigate whether a structured exercise program, including high- and low-impact aerobics and supported by pelvic floor muscle exercises, improves the neuromuscular activity of the pelvic floor and does not reduce the quality of life in terms of urinary incontinence in healthy pregnant women. Methods: This was a randomized control trial among 97 Caucasian healthy nulliparas in uncomplicated pregnancies (age 30 ± 4 years, 21 ± 5 weeks of gestation; mean ± SD). Women were assessed for pelvic floor muscle functions with surface electromyography (EMG) using vaginal probes and using the Incontinence Impact Questionnaire (IIQ). Only women able to contract pelvic floor muscles and with good quality of life based on IIQ were included for the study. Seventy women in the experimental group took part in a supervised exercise program including high-low impact aerobics and pelvic floor muscle exercises three times a week. Twenty-seven controls did not receive any exercise intervention. After 6 weeks both groups were re-tested with EMG and IIQ. Post- and pre-exercise program changes in each group were analyzed using a repeated-measures ANOVA. Results: Women in the experimental group improved the neuromuscular activity of the pelvic floor in some motor tasks without any adverse outcomes of the intervention. After the exercise program we observed in the experimental group significantly higher EMG amplitude in the pelvic floor muscles during 3-s contractions (p = 0.014). We also noticed a beneficial trend in the increase of neuromuscular activity during 10- and 60-s contractions, but the changes were not statistically significant. The exercising women substantially improved their abilities for relaxation following 3- and 10-s contractions (p = 0.013 and p < 0.001). In controls, we reported no statistically significant improvement in either of the motor tasks. All study participants maintained good quality of life related to urinary incontinence. Conclusion: Prenatal exercise programs that include high- and low-impact aerobics and are supported by pelvic floor muscle exercises should be recommended for pregnant women, especially those who are accustomed to higher exercise intensity before pregnancy. Nevertheless, these recommendations can be directed to continent women who can properly contract pelvic floor muscles. ISRCTN. DOI: 10.1186/ISRCTN92265528: "Pelvic floor muscle training with surface electromyography", retrospectively registered on the 25th of July, 2016.

Dataset Information

Randomized trial of cesarean vs vaginal delivery for effects on the pelvic floor in squirrel monkeys.

Publications

Randomized trial of cesarean vs vaginal delivery for effects on the pelvic floor in squirrel monkeys.

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