Pregnancy Loss, EarlyNCT07684677
Effect of Participating in a Study of Causes of Pregnancy Loss on Mental Health Outcomes: A Target Trial Emulation Using the COPL Cohort and Danish National Registries
A study testing COPL participation in people with Pregnancy Loss, Early and Major Depression, run by Amager Hospital at 1 site in Denmark.
Trial summary
Pregnancy loss is the most common severe pregnancy complication and is associated with significant mental health sequelae, including depression and anxiety. Standard care in Denmark does not include systematic follow-up or aetiological investigation after pregnancy loss. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Loss, Early, Major Depression, Anxiety
- What is being tested?
- COPL participation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2020to 11 Apr 2027
- 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
- Age above 18 years
- Born in Denmark
- Verified intrauterine PL before 22 weeks' gestation treated at a public hospital in Denmark
Who cannot join
- Non-visualized PL, ectopic PL
- Gestational age >22 weeks at loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Participating in a Study of Causes of Pregnancy Loss on Mental Health Outcomes: Protocol for a Target Trial Emulation Using the COPL Cohort and Danish National Registries
Pregnancy loss is the most common severe pregnancy complication and is associated with significant mental health sequelae, including depression and anxiety. Standard care in Denmark does not include systematic follow-up or aetiological investigation after pregnancy loss. The Copenhagen Odense Pregnancy Loss (COPL) Cohort offered extensive aetiological investigations, and a dedicated clinical follow-up visit 4-10 weeks post-loss. This is a target trial emulation (TTE) designed to estimate the causal effect of COPL participation on women's mental health outcomes one year after pregnancy loss. We will emulate a target trial comparing (1) enrolment into COPL versus (2) standard pregnancy loss care. The study population comprises women aged ≥18 years with a confirmed intrauterine pregnancy loss (ICD-10: DO020, DO021, DO030-DO034) before 22 weeks' gestation treated at Danish public hospitals between November 2020 and April 2025. The primary outcome is new-onset affective disorder (ICD-10: F32*-F39*), neurotic/stress-related disorder (F41*, F43*, F48*), or dispensing of antidepressant (N06A*), anxiolytic (N05B*), or sedating (N05C*) medication within 12 months of pregnancy loss diagnosis. All data will be sourced from Danish National Registries. The difference-in-differences estimator will serve as the primary analytical approach, complemented by instrumental variable analysis (hospital of treatment as instrument) and regression discontinuity design. Inverse probability of treatment weighting will be used to control for measured confounders. Results will be reported as risk ratios and risk differences with 95% confidence intervals. Sensitivity analyses will include per-protocol estimation and exclusion of women with treatable findings identified in COPL.
- Conditions
- Pregnancy Loss, Early, Major Depression, Anxiety, Stress (Psychology)
- Being tested
- COPL participation
- Medical subject headings
- Abortion, Spontaneous, Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPL participationOther
Participation in the COPL cohort
| Study group | Role | What they receive |
|---|---|---|
| COPL participant | Experimental | Women with pregnancy loss participating in the COPL Cohort Receives: Other: COPL participation |
| Controls | No intervention | Women not included in the COPL cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
New onset affective or stress-related disorder
Either ICD-10 F32*-F39*, F41*, F43*, F48* registered or prescription of antidepressant, anxiolytic or sedating medication after PL
Measured: 12 months after PL
Secondary outcomes (4)
Sick leave
Total number of sick-leave days
Measured: First 12 months after PL
Health care utilization
Total GP use, referral to psychologist/psychiatrist
Measured: 12 months after PL
Time to pregnancy
Time from time zero to next pregnancy
Measured: Up to 12 months
Post-natal mood disorder
In case of subsequent delivery, prevalence of post-natal mood disorder
Measured: Up to 12 months after time zero
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Nov 2020
- Primary completion11 Apr 2025
- Study completion11 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Loss, EarlyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Target trial emulation
- Masking
- None (open label)
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amager Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Astrid Marie Kolte, Copenhagen University Hospital, Hvidovre
- Investigators
- Henriette Svarre Nielsen, Professor, Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684677
- Sponsor's protocol ID
- 10.46540/4308-00131B
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not permitted
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Participating in a Study of Causes of Pregnancy Loss on Mental Health Outcomes: Protocol for a Target Trial Emulation Using the COPL Cohort and Danish National Registries
- ClinicalTrials.gov ID
- NCT07684677
- Acronym / sponsor ID
- 10.46540/4308-00131B
- Conditions
- Pregnancy Loss, Early, Major Depression, Anxiety, Stress (Psychology)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Amager HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 11 Apr 2027 (estimated)
- First posted
- 6 Jul 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.
Pregnancy loss is the most common severe pregnancy complication and is associated with significant mental health sequelae, including depression and anxiety. Standard care in Denmark does not include systematic follow-up or aetiological investigation after pregnancy loss. The Copenhagen Odense Pregnancy Loss (COPL) Cohort offered extensive aetiological investigations, and a dedicated clinical follow-up visit 4-10 weeks post-loss. This is a target trial emulation (TTE) designed to estimate the causal effect of COPL participation on women's mental health outcomes one year after pregnancy loss. We will emulate a target trial comparing (1) enrolment into COPL versus (2) standard pregnancy loss care. The study population comprises women aged ≥18 years with a confirmed intrauterine pregnancy loss (ICD-10: DO020, DO021, DO030-DO034) before 22 weeks' gestation treated at Danish public hospitals between November 2020 and April 2025. The primary outcome is new-onset affective disorder (ICD-10: F32*-F39*), neurotic/stress-related disorder (F41*, F43*, F48*), or dispensing of antidepressant (N06A*), anxiolytic (N05B*), or sedating (N05C*) medication within 12 months of pregnancy loss diagnosis. All data will be sourced from Danish National Registries. The difference-in-differences estimator will serve as the primary analytical approach, complemented by instrumental variable analysis (hospital of treatment as instrument) and regression discontinuity design. Inverse probability of treatment weighting will be used to control for measured confounders. Results will be reported as risk ratios and risk differences with 95% confidence intervals. Sensitivity analyses will include per-protocol estimation and exclusion of women with treatable findings identified in COPL.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Target trial emulation
| Arm | Type | Receives |
|---|---|---|
| COPL participant | Experimental | Other: COPL participationWomen with pregnancy loss participating in the COPL Cohort |
| Controls | No intervention | –Women not included in the COPL cohort |
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)
- Age above 18 years
- Born in Denmark
- Verified intrauterine PL before 22 weeks' gestation treated at a public hospital in Denmark
Key exclusion criteria (2 listed)
- Non-visualized PL, ectopic PL
- Gestational age >22 weeks at loss
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 |
|---|---|---|
| COPL participationParticipation in the COPL cohort | Other | COPL participant |
Primary outcome
New onset affective or stress-related disorder
Time frame: 12 months after PL
Either ICD-10 F32*-F39*, F41*, F43*, F48* registered or prescription of antidepressant, anxiolytic or sedating medication after PL
4 secondary outcomes
Sick leave
Time frame: First 12 months after PL
Health care utilization
Time frame: 12 months after PL
Time to pregnancy
Time frame: Up to 12 months
Post-natal mood disorder
Time frame: Up to 12 months after time zero
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 6 Jul 2026.
- Individual participant dataSharing planned: No. It is not permitted
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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. This study is not recruiting at the moment.
Henriette Svarre Nielsen, Professor principal investigator
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPL participation in people with Pregnancy Loss, Early and Major Depression, run by Amager Hospital 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New onset affective or stress-related disorder (time frame: 12 months after PL). 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 6 Jul 2026.