Clinical Research Directory

Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma

The aim of this study is to assess the effectiveness of a pelvic floor muscle training (PFMT) protocol associated with cryotherapy initiated in the immediate postpartum period in relieving pain in primiparous women who suffered perineal trauma during vaginal delivery. This is a hybrid effectiveness-implementation type 1 randomized controlled trial with economic evaluation, which will include 82 primiparous women who suffered a perineal tear of grade 2 or above or episiotomy during vaginal delivery. The study participants will be selected from among the women who gave birth at the Hospital das Clínicas in Ribeirão Preto and will be randomly assigned to participate in one of two study groups: the Control Group will receive the usual maternity care, that includes suturing the injury and analgesic medication, and the Intervention Group will receive the usual care combined with a physiotherapy protocol of PFMT and cryotherapy, starting in the immediate postpartum period and lasting 3 months. The primary outcome of the study will be the change in perineal pain intensity assessed using an 11-point Numerical Rating Scale; and the secondary outcomes will be self-reported pelvic floor dysfunction, recovery from injury, functionality, health-related quality of life, use of pain medication, genital self-image and implementation outcomes (satisfaction, acceptability, adequacy, feasibility, equity and adherence to the protocol). Assessments will be carried out by a group of health professionals, including physiotherapists and physicians, at 11 points up to 6 months after delivery. Two doctors from the service will be responsible for carrying out the transperineal ultrasound examination to assess the injury, which will be sent to a third international collaborating physician (SD) to assess the results blindly. The other assessments will be carried out by two physiotherapists.Descriptive statistics will be used, including the ANOVA test to confirm homogeneity between the groups, the chi-square test or Fisher's test for categorical variables and Student's t-test or Wilcoxon's non-parametric test for independent samples for quantitative variables.

A Comparison of THD® Anopress With High Resolution Anorectal Manometry

Currently, high resolution anorectal manometry (HDARM) is used as gold standard to measure anal sphincter pressures in women who have sustained a third or fourth degree perineal tears (obstetric anal sphincter injuries). This test is performed to help advise patients on future pregnancies or deliveries. However, HDRM catheters are very expensive and they also need to be performed in a dedicated procedure room. THD® Anopress in comparison is a lightweight, portable device which has a comparatively shorter investigation time and is more cost- effective. However, although THD® Anopress is currently used in the colorectal population, there is currently no validated research that compares the measurements obtained by HDARM with that of THD® Anopress with women with a history of obstetric anal sphincter injuries. The primary aim of this study is to compare pressure measurements from HDARM to that of THD® Anopress in women with obstetric anal sphincter injuries.

Pelvic Floor Exercises for Suboptimal Anorectal Manometry

Currently, guidelines from the Royal College of Obstetricians and Gynaecologists stipulate that all women who have sustained an obstetric anal sphincter injury in a previous pregnancy and who are symptomatic or have abnormal endoanal ultrasonography and/ or manometry should be counselled regarding the option of an elective Caesarean section. An abnormal endoanal ultrasonography is currently considered to be a defect of the external anal sphincter (EAS) of more than 30 degrees while an abnormal anorectal manometry would be an incremental squeeze pressure of less than 20mmHg. This study aims to evaluate if a course of guided pelvic floor exercises could improve anal sphincter function on those with suboptimal or abnormal anal incremental squeeze pressures, and subsequently expand their options for future modes of delivery (vaginal delivery not contraindicated)

CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence

The aim of this study is to ascertain which pathways currently exist in relation to the follow up of patients with obstetric anal sphincter injury related incontinence. This is particularly important as afflicted individuals may not readily volunteer information about their symptoms and struggles and need to be safeguarded by the presence of robust care pathways that ensure adequate follow up and care provision. As obstetric anal sphincter injuries have been associated with increased litigation rates over the years, positive interventions towards patient care will help ameliorate the financial burden that litigation carries on the National Health Service. It is noteworthy of mention that perineal injury, in itself, may not be suggestive of negligent care and is a recognized complication of vaginal delivery. However, a failure to adequately manage the injury may carry medicolegal implications.

Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation

The goal of this observational study is to evaluate the reproducibility of new 3D/4D ultrasound volume analysis techniques in the assessment of anal sphincter integrity and thickness in both pregnancy and immediate postpartum. The negative impact that OASISs (Obstetric Anal Sphincter Injuries), and possible subsequent anal incontinence, have on women's quality of life has stimulated research in this field in recent decades. However, there are still few studies concerning the topic. The transperineal approach by means of the transvaginal probe in the study of the pelvic floor, anal sphincter and related lesions has helped us to make strides in our knowledge of the anatomy of the pelvic floor and in defining the lesions that may affect it.

Pelvic Floor Function After Obstetric Injury to the Anal Sphincter

The goal of this observational study is to learn more about the effect a pregnancy and delivery has on the function of the anal musculature.We will compare women who had a new delivery after suffering a severe tear in the anal musculature in their first pregnancy, with women who had two or more vaginal deliveries, but did not suffer such an injury. The main questions we want to answer is: * can the burden of a new pregnancy and delivery weaken the function of the repaired musculature in a way that might cause symptoms of anal incontinence later in life? * can a tear in the anal musculature increase the risk of developing urinary incontinence and long term sexual dysfunction? * should we recommend these women to have a caesarian section instead of a new vaginal delivery? Participants will be asked to complete an electronic questionnaire with information regarding their pregnancies, deliveries and potential symptoms from anal incontinence, urinary incontinence and sexual dysfunction. Researchers will compare these two groups to find out if a new vaginal delivery has a negative effect on the function of the anal musculature.