Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention (ADAPT)
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention: The ADAPT Randomized Controlled Trial
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Hanna Jango, MD, PhD, Associate Professor
- 电话号码：+4538681612
- 邮箱：hanna.margareta.jangoe@regionh.dk
研究联系人备份
- 姓名：Iben O Hansen, MD
- 电话号码：+4538689904
- 邮箱：iben.onsberg.hansen@regionh.dk
学习地点
-
-
Capital Region
-
Herlev、Capital Region、丹麦、2730
- Department of Gynecology and Obstetrics at Herlev Hospital
-
接触：
- Hanna Jango, MD, PhD, Associate Professor
- 电话号码：+4538681612
- 邮箱：hanna.margareta.jangoe@regionh.dk
-
接触：
- Iben O Hansen, MD
- 电话号码：+4538689904
- 邮箱：iben.onsberg.hansen@regionh.dk
-
副研究员：
- Iben O Hansen, MD
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Referred patients from other hospitals due to complicated healing
- Patients where other Hospitals are responsible for the clinical follow-up
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：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.
|
|
|
有源比较器：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.
|
Participants in the Intervention Group are invited to three closed group sessions 2-6 months postpartum hosted by doctors and physiotherapists.
The group session focus on relevant information (e.g.
healing, incontinence, emotions, concerns, sexlife, everyday challenges), kegel-exercises (pelvic floor exercises) and social interaction between participants.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ICIQ-B Quality of Life Domain
大体时间：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. |
From Baseline questionnaire (1-1.5 months postpartum) to last questionnaire at 9-12 months postpartum
|
|
Symptoms of Anal Incontinence (Cohort)
大体时间：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. |
From 8-14 days and at 1-1.5, 3, 6 and 9-12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ICIQ-B (total) score
大体时间：From Baseline questionnaire (1-1.5 months postpartum) and at 3, 6 and 9-12 months postpartum
|
The change in total ICIQ-Bowel score (all domains). Between the Intervention and the Control group at all timepoints, and for all participants (the cohort) the development over time. 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. |
From Baseline questionnaire (1-1.5 months postpartum) and at 3, 6 and 9-12 months postpartum
|
|
Anal Incontinence symptoms
大体时间：From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months
|
Anal Incontinence symptoms derived from early + late clinical follow-up and relevant ICIQ-B items.
Between the Intervention and the Control group at all timepoints.
No score/scale is used.
|
From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months
|
|
EAUS
大体时间：At 9-12 months clinical follow-up
|
Assessment of defects in anal sphincter complex by endoanal ultrasound .
Between the Intervention and the Control group, and for all participants (the cohort).
No score/scale is used.
|
At 9-12 months clinical follow-up
|
|
Wound dehiscence
大体时间：At early clinical follow-up (8-14 days postpartum)
|
Wound dehiscence at early clinical follow-up (8-14 days).
Wound dehiscence is divided into with/without involvement of pelvic muscles (With/without involvement of sphincter-complex or total dehiscence).
Between the Intervention and the Control group, and for all participants (the cohort).
No score/scale is used.
|
At early clinical follow-up (8-14 days postpartum)
|
|
Infection
大体时间：At early clinical follow-up (8-14 days postpartum)
|
Wound infection at early clinical follow-up are described by Redness, Edema, Echymosis, dicharge (pus), absces.
Women with absces/pus or treated with antibiotics due to infection signs are considered to have a wound infection.
Between the Intervention and the Control group, and for all participants (the cohort).
No score/scale is used.
|
At early clinical follow-up (8-14 days postpartum)
|
|
Prolapse
大体时间：At 9-12 months clinical follow-up
|
Prolapse at 9-12 months clinical follow-up using modified POP-Q.
Between the Intervention and the Control group, and for all participants (the cohort).
No score/scale is used.
|
At 9-12 months clinical follow-up
|
|
Urinary incontinence
大体时间：At 3, 6 and 9-12 months postpartum
|
Symptoms of urinary incontinence from questionnaires (ICIQ-UI-SF) at 3, 6 and 9-12 months. Between the Intervention and the Control group at all timepoints, and for all participants (the cohort) the development over time. The ICIQ-UI-SF (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) score i derived from 3 of the 4 questions. The score ranges from 0 to 21 points. A higher score indicating a worse outcome. |
At 3, 6 and 9-12 months postpartum
|
|
Pelvic symptoms
大体时间：At baseline, 3, 6 and 9-12 months
|
Symptoms of prolaps, heavyness, pain from questionnaires (PFDI-20, KAPTAIN).
Between the Intervention and the Control group at all timepoints, and for all participants (the cohort) the development over time.
No score/scale is used.
|
At baseline, 3, 6 and 9-12 months
|
|
Number of clinical follow-ups
大体时间：From delivery to 12 months postpartum
|
Number of clinical follow-ups due to e.g.
wound complications or symptoms during the first year postpartum.
Between the Intervention and the Control group, and for all participants (the cohort).
No score/scale is used.
|
From delivery to 12 months postpartum
|
|
EPDS
大体时间：Baseline (1-1.5 months), 6 months and 9-12 months
|
Score of Edinburgh postpartum Depression Scale (EPDS) at baseline and 9-12 months. Between the Intervention and the Control group, and for all participants (the cohort) the development over time. EPDS consists of 10 questions with each answer ranking from 0-3 points. Minimum 0 and maximum 30 points, with higher score meaning worse outcome. If total score is 10 or above it is considered as a potential depression requering treatment and follow-up is needed. |
Baseline (1-1.5 months), 6 months and 9-12 months
|
|
Body Image
大体时间：Questionnaire at 6 months and 9-12 months postpartum
|
Body image score (FGSIS: Femal Genital Self-Image Scale) at 9-12 months for the intervention and the control group , and for all participants in the cohort. FGSIS consists of 7 items, where participants rate statements on a scale from 1 (strongly disagree) to 4 (strongly agree). The results are summed into a total score, with higher numbers indicating a more positive self-perception of the pelvic area. |
Questionnaire at 6 months and 9-12 months postpartum
|
|
Sexual function
大体时间：6 and 9-12 months postpartum
|
Sexual function at 6 and 9-12 months questionnaire (ICIQ-VS + KAPTAIN).
Between the Intervention and the Control group at all timepoints, and for all participants (the cohort) the development over time.
No score/scale is used.
|
6 and 9-12 months postpartum
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Levator Ani Avulsion
大体时间：At 9-12 months clinical follow-up
|
Assessment of levator Ani Avulsion from Endovaginal Ultrasound.
Presence, severity and association with symptoms and Quality of Life.
Between the Intervention and the Control group at all timepoints, and for all participants (the cohort).
LAD-score (Levator Ani Defiency Score) will be used til quantify the extent of damage.
A minimum of 0 points and maximum of 18.
A higher score indicates worse damage.
A score of 6 or above is considered significant.
|
At 9-12 months clinical follow-up
|
|
Qualitative Component (Intervention group only)
大体时间：Aprox. 2-8 weeks after concluded intervention
|
Semi-structured individual or focus-group interviews will explore participants' experiences with the intervention and explore women's experiences of sustaining a perineal tear and any associated symptoms.
No score/scale is used.
|
Aprox. 2-8 weeks after concluded intervention
|
合作者和调查者
赞助
调查人员
- 首席研究员：Hanna Jango, MD, PhD, Associate Professor、Department of Gynecology and Obstetrics at Herlev Hospital
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.