Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Postpartum Primiparas After Perineal Trauma: A Type 1 Hybrid Effectiveness-Implementation Randomized Controlled Trial With Economic Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Change in perineal pain intensity
研究概览
简要总结
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.
详细描述
This study is a type 1 hybrid randomised controlled clinical trial of effectiveness-implementation, with economic evaluation and blinded assessor, which aims to assess the effectiveness and cost-effectiveness of a physiotherapy protocol that combines pelvic floor muscle training (PFMT) with cryotherapy, initiated immediately after vaginal delivery in primiparas who have suffered perineal laceration grade 2 or above or episiotomy.
Eighty-two women who gave birth at the Hospital das Clínicas of the Ribeirão Preto Medical School - USP will be recruited. Participants will be randomised into two groups: Control Group, which will receive only the usual maternity care (analgesic medication and sutures); and Intervention Group, which will receive, in addition to the usual care, the physiotherapy protocol.
The physiotherapy protocol consists of one in-person session during hospitalisation, which will include 20 minutes of cryotherapy and initial instructions on pelvic floor muscle contraction (PFM). After hospital discharge, 12 weekly PFMT sessions will be conducted remotely (online), with guidance for daily continuation of home exercises and application of cryotherapy as needed for perineal pain relief.
The primary outcome will be the intensity of perineal pain, assessed using an 11-point numerical rating scale at the following times: 6-10 hours postpartum, 30 minutes after initial intervention, weekly in the first month, fortnightly in the second month, and at 3 and 6 months postpartum.
Secondary outcome measures include self-reported pelvic floor dysfunction (Australian Pelvic Floor Questionnaire and Wexner Scale), anatomical and functional recovery of the PFM (transperineal ultrasound and vaginal palpation using the modified Oxford scale), functionality (International Physical Activity Questionnaire - IPAQ and functional limitation numerical scale), health-related quality of life (EQ-5D-3L), use of analgesic medications, genital self-image (Female Genital Self-image Scale), gender-based violence (WHO-adapted questionnaire), and implementation outcomes (acceptability, adequacy, feasibility, and adherence to the protocol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The study will include female at birth aged 18 years or older, primiparous (no previous pregnancy after 16 weeks), who have suffered a perineal laceration of grade ≥2 or episiotomy, with ≥37 weeks of gestation at the time of delivery, who have not used testosterone in the last 6 months, with preserved cognitive ability, no history of neurological diseases, no symptoms of vaginal or urinary tract infection and no perineal diseases such as fistulas, genital mutilation, previous perineal surgery for pelvic floor dysfunction or Crohn's disease. According to the Robson 10-Group Classification System, only women belonging to group 1 (nulliparous women with a single vital cephalic pregnancy, ≥37 weeks of gestation in spontaneous labor) and group 2a (nulliparous women with a single vital cephalic pregnancy, ≥37 weeks of gestation who had labor induced) will be included in the study.
排除标准
- •Women with conditions such as severe pre-eclampsia or infections, sick newborns or women who refuse to take part in the study will not be included. Participation is voluntary and participants can withdraw from the study at any time.
研究组 & 干预措施
Control Group
Participants in this group will be selected from among primiparous women aged 18 or over, who have suffered a perineal laceration of grade 2 or above or episiotomy, with ≥37 weeks of gestation at the time of delivery, with no history of neurological diseases, and without perineal diseases. According to the 10-group Robson Classification System, only women belonging to group 1 and group 2a will be included. This arm will receive standard postpartum care for perineal trauma from the maternity hospital.
干预措施: Usual maternity care (Other)
Intervention Group
Participants in this group will be selected from among primiparous women aged 18 or over, who have suffered a perineal laceration of grade 2 or above or episiotomy, with ≥37 weeks of gestation at the time of delivery, with no history of neurological diseases, and without perineal diseases. According to the 10-group Robson Classification System, only women belonging to group 1 and group 2a will be included. The women randomized to the Intervention Group the physiotherapeutic protocol (pelvic floor muscle training and cryotherapy, starting in the imediate postpartum and lasting 3 months).
干预措施: Physiotherapeutic protocol (Other)
结局指标
主要结局
Change in perineal pain intensity
时间窗: Up to 6 months postpartum
The change in the intensity of perineal pain will be assessed using an 11-point numerical rating scale (NRS), in which the participant will quantify her level of pain on a scale of 0 to 10, where 0 means no pain and 10 means the worst pain imaginable; a change of 2 points in the NRS will be considered clinically significant. The pain assessment will be done by asking the participants: "What is the level of pain in your intimate area at the moment?" and "Do you believe you have taken any measures that could have improved or worsened your pain today?". If the answer is yes, the participant will be asked to specify the measure she believes has worsened or relieved the pain. The assessment will be carried out in person during hospitalization, and after discharge, via text message at the end of the day (around 6pm).
次要结局
- Self-reported symptoms of pelvic floor dysfunction(Up to 6 months postpartum.)
- Anal incontinence(Up to 3 months postpartum.)
- Integrity of the levator ani muscle(Up to 3 months postpartum)
- Microtrauma of the levator ani muscle(Up to 3 months postpartum)
- Obstetric anal sphincter muscle injury (OASI)(Up to 3 months postpartum)
- Self-perception(Up to 3 months postpartum)
- Function of the pelvic floor muscles(Up to 3 months postpartum)
- Functionality(Up to 6 months postpartum.)
- Level of physical activity(Up to 6 months postpartum.)
- Health-related quality of life(Up to 6 months postpartum.)
- Use of medication(Up to 6 months postpartum.)
- Genital self-image(Up to 3 months postpartum.)
- Acceptability(Up to 3 months postpartum)
- Appropriateness(Up to 3 months postpartum)
- Intervention's feasibility(Up to 3 months postpartum)
- Participant's satisfaction(Up to 3 months postpartum)
- Participant's adherence(Up to 3 months postpartum)
- Gender-based violence(Up to 3 months postpartum)
- Economic evaluation(Up to 6 months postpartum)
研究者
Caroline Soares de Paula
Principal Investigator
University of Sao Paulo