Obstetric Anal Sphincter InjuryADAPTNCT07667660
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
A study testing Group Session in people with Obstetric Anal Sphincter Injury, run by Hanna Jangö at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Anal Sphincter Injury
- What is being tested?
- Group Session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Sep 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Referred patients from other hospitals due to complicated healing
- Patients where other Hospitals are responsible for the clinical follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Gynecology and Obstetrics at Herlev Hospital
Herlev, Capital Region, 2730
Hanna Jango, MD, PhD, Associate Professor, +4538681612, hanna.margareta.jangoe@regionh.dk
Iben O Hansen, MD, +4538689904, iben.onsberg.hansen@regionh.dk
About this study
Official title: Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention: The ADAPT Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Obstetric Anal Sphincter Injury
- Being tested
- Group Session
- Keywords
- obstetric tear, women's health, anal incontinence, obstetric anal sphincter injury
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group SessionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 | Active comparator | 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. Receives: Other: Group Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICIQ-B Quality of Life Domain
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.
Measured: From Baseline questionnaire (1-1.5 months postpartum) to last questionnaire at 9-12 months postpartum
Symptoms of Anal Incontinence (Cohort)
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.
Measured: From 8-14 days and at 1-1.5, 3, 6 and 9-12 months
Secondary outcomes (12)
ICIQ-B (total) score
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.
Measured: From Baseline questionnaire (1-1.5 months postpartum) and at 3, 6 and 9-12 months postpartum
Anal Incontinence symptoms
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.
Measured: From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months
EAUS
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.
Measured: At 9-12 months clinical follow-up
Wound dehiscence
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.
Measured: At early clinical follow-up (8-14 days postpartum)
Infection
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.
Measured: At early clinical follow-up (8-14 days postpartum)
Prolapse
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.
Measured: At 9-12 months clinical follow-up
Urinary incontinence
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.
Measured: At 3, 6 and 9-12 months postpartum
Pelvic symptoms
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.
Measured: At baseline, 3, 6 and 9-12 months
Number of clinical follow-ups
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.
Measured: From delivery to 12 months postpartum
EPDS
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.
Measured: Baseline (1-1.5 months), 6 months and 9-12 months
Body Image
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.
Measured: Questionnaire at 6 months and 9-12 months postpartum
Sexual function
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.
Measured: 6 and 9-12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start14 Sep 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Anal Sphincter InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups - 1 intervention, 1 control
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanna Jangö
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanna Jangö, Herlev Hospital
- Investigators
- Hanna Jango, MD, PhD, Associate Professor, Principal investigator, Department of Gynecology and Obstetrics at Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667660
- Sponsor's protocol ID
- H-26012116
- Acronym
- ADAPT
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention: The ADAPT Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07667660
- Acronym / sponsor ID
- ADAPT / H-26012116
- Conditions
- Obstetric Anal Sphincter Injury
- Keywords
- obstetric tear, women's health, anal incontinence, obstetric anal sphincter injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hanna JangöUniversity, hospital or other
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups - 1 intervention, 1 control
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 | Active comparator | Other: Group SessionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Referred patients from other hospitals due to complicated healing
- Patients where other Hospitals are responsible for the clinical follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group SessionParticipants 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. | Other | Intervention |
Primary outcome
ICIQ-B Quality of Life Domain
Time frame: 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)
Time frame: 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.
12 secondary outcomes
ICIQ-B (total) score
Time frame: From Baseline questionnaire (1-1.5 months postpartum) and at 3, 6 and 9-12 months postpartum
Anal Incontinence symptoms
Time frame: From 8-14 days postpartum and at 1-1.5, 3, 6 and 9-12 months
EAUS
Time frame: At 9-12 months clinical follow-up
Wound dehiscence
Time frame: At early clinical follow-up (8-14 days postpartum)
Infection
Time frame: At early clinical follow-up (8-14 days postpartum)
Prolapse
Time frame: At 9-12 months clinical follow-up
Urinary incontinence
Time frame: At 3, 6 and 9-12 months postpartum
Pelvic symptoms
Time frame: At baseline, 3, 6 and 9-12 months
Number of clinical follow-ups
Time frame: From delivery to 12 months postpartum
EPDS
Time frame: Baseline (1-1.5 months), 6 months and 9-12 months
Body Image
Time frame: Questionnaire at 6 months and 9-12 months postpartum
Sexual function
Time frame: 6 and 9-12 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanna Jango, MD, PhD, Associate Professor principal investigator
Department of Gynecology and Obstetrics at Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Session in people with Obstetric Anal Sphincter Injury, run by Hanna Jangö at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna Jango, MD, PhD, Associate Professor (+4538681612, hanna.margareta.jangoe@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICIQ-B Quality of Life Domain (time frame: From Baseline questionnaire (1-1.5 months postpartum) to last questionnaire at 9-12 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.