Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention: The ADAPT Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- ICIQ-B Quality of Life Domain
研究概览
简要总结
The aim of the ADAPT study is to investigate whether a structured, group-based follow-up programme can improve quality of life related to anal incontinence in women with OASI during the first year after childbirth. The study will also describe how symptoms change over time and assess effects on mental health, sexual function, symptoms of prolapse and urinary incontinence, and body image.
详细描述
Women who experience a birth tear involving the anal sphincter (OASI) currently lack a systematic and consistent follow-up programme. There is limited knowledge about how their symptoms develop during the first year after childbirth, and problems such as anal incontinence are likely underreported due to stigma. Studies show women are asking for better support, information, and guidance.
The aim of the ADAPT study is to investigate whether a structured, group-based follow-up programme can improve quality of life related to anal incontinence in women with OASI during the first year after childbirth. The study will also describe how symptoms change over time and assess effects on mental health, sexual function, symptoms of prolapse and urinary incontinence, and body image.
The study is a randomised controlled trial with a 1:1 allocation to either a group-based follow-up programme or standard care. All participants complete questionnaires at 1-1.5 months, 3, 6, and 9-12 months after childbirth, and are offered a clinical examination at 9-12 months postpartum. This includes a gynaecological assessment and 3D endoanal and endovaginal ultrasound.
In addition, the intervention group takes part in three group sessions focusing on healing, physiotherapist-guided pelvic floor muscle exercises, incontinence, emotions, sexual life, and everyday challenges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Obstetric Anal Sphincter Injury (OASI - Grade 3-4 tear) and clinical follow-up postpartum at the "Pelvic Clinic" at Herlev Hospital
- •18 years of age or above and the capacity to provide informed consent
- •Fluent in Danish language
排除标准
- •Referred patients from other hospitals due to complicated healing
- •Patients where other Hospitals are responsible for the clinical follow-up
研究组 & 干预措施
Control
Participants are randomized 1:1 Intervention vs. control. Participants in the Control Group receive the same clinical follow-ups at 8-14 days and 9-12 months after OASI, and the same questionnaires at 1-1.5, 3, 6 and 9-12 months postpartum as the intervention group.
Intervention
Participants are randomized 1:1 Intervention vs. control. Participants in the Intervention Group are invited to three group sessions 2-6 months postpartum hosted by doctors and physiotherapists. The group session focus on relevant information, physiotherapist-guided kegel-exercises (pelvic floor mucles exercises) and social interaction between participants. In addition the Intervention group receive the same clinical follow-ups at 8-14 days and 9-12 months after OASI, and the same questionnaires at 1-1.5, 3, 6 and 9-12 months postpartum as the control group.
干预措施: Group Session (Other)
结局指标
主要结局
ICIQ-B Quality of Life Domain
时间窗: From Baseline questionnaire (1-1.5 months postpartum) to last questionnaire at 9-12 months postpartum
The change in score of the "Quality of Life" Domain in ICIQ-Bowel (Questions 19-23) between the Intervention and the Control Group. ICIQ-B: "International Consultation on Incontinence Questionnaire-Bowel" The ICIQ-B score contains 21 items, 17 of the 21 items are scored items, while the remaining four are unscored 9. Each item is scored on an ordinal scale and contains a 'bother' score rated on a numeric rank scale (NRS). The bother scores are not part of the calculated subscale scores. The 17 scored items are divided into three subscales: Bowel pattern (0-21), bowel control (0-28) and Quality of life (0-26), with a higher score indicating more symptoms.
Symptoms of Anal Incontinence (Cohort)
时间窗: From 8-14 days and at 1-1.5, 3, 6 and 9-12 months
Development/fluctuation of anal incontinence and related symptoms for all participants regardless of randomization (cohort) at all timepoints. From questionnaires and clinical follow-up. No score/scale is used.
次要结局
- ICIQ-B (total) score(From Baseline questionnaire (1-1.5 months postpartum) and at 3, 6 and 9-12 months postpartum)
- Anal Incontinence symptoms(From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months)
- EAUS(At 9-12 months clinical follow-up)
- Wound dehiscence(At early clinical follow-up (8-14 days postpartum))
- Infection(At early clinical follow-up (8-14 days postpartum))
- Prolapse(At 9-12 months clinical follow-up)
- Urinary incontinence(At 3, 6 and 9-12 months postpartum)
- Pelvic symptoms(At baseline, 3, 6 and 9-12 months)
- Number of clinical follow-ups(From delivery to 12 months postpartum)
- Sexual function(6 and 9-12 months postpartum)
- EPDS(Baseline (1-1.5 months), 6 months and 9-12 months)
- Body Image(Questionnaire at 6 months and 9-12 months postpartum)
研究者
Hanna Jangö
Associate Professor
Herlev Hospital