Recurrent Pregnancy LossNCT03905395
Meditation and Mindfulness for Recurrent Pregnancy Loss
A study testing Meditation and mindfulness in people with Recurrent Pregnancy Loss, run by Henriette Svarre Nielsen, MD, DMSc at 1 site in Denmark.
Trial summary
In the Danish Recurrent Pregnancy Loss Unit in Rigshospitalet in Copenhagen recurrent pregnancy loss (RPL) is defined as three og more consecutive pregnancy losses in accordance with current European guidelines. RPL affects approximately 3% of couples trying to achieve parenthood. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss
- What is being tested?
- Meditation and mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Feb 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 46 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with RPL
- Speaking, reading and understanding Danish
- Have given a written consent
- Have a male partner
- Have a stress score > 16 points on Perceived Stress Scale
Who cannot join
- If the patient is pregnant on inclusion day
- If the patient already is practing meditation and mindfulness
- If the patient has a depression
- If the patient develops a depression after inclusion in either arm
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Østerbro, 2100
Henriette Svarre Nielsen, MD. MDSc, +4535458486, Henriette.Svarre.Nielsen@regionh.dk
Karen Kirchheiner Jensen, Nurse, +4535458486, Karen.Henriette.Jensen@regionh.dk
About this study
In the Danish Recurrent Pregnancy Loss Unit in Rigshospitalet in Copenhagen recurrent pregnancy loss (RPL) is defined as three og more consecutive pregnancy losses in accordance with current European guidelines.
RPL affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth.
Read more
42% of the women referred to RPL Unit in Rigshospitalet has a high stress level where as it's 22% in the background population trying to achieve parenthood. It's also known that 8,8 % of RPL patients have a depression at referral where as it's 2,2 % in the background population trying to achieve parenthood.
The study is a RCT including 62 patients - 31 in each arm. One arm will be taught in meditation and mindfulness three courses over a 7 week period. This group will also do meditation every day for 7 weeks. The other arm will have no intervention.
This study will investigate if a 7 weeks course in meditation and mindfulness is a useful tool to reduce stress and the psychological consequences for women and their partner treated in RPL Unit in Rigshospitalet, Copenhagen. Furthermore this study will investigate if there's a marital benefit such as reinforcement in their relationsship from practicing meditation and mindfulness.
There is no previous study that has investigated meditation and mindfulness for RPL.
This study has the potential to establish mental health support as a supplement to the medical and clinical treatment for RPL patients.
Read the detailed description
The loss of a desired pregnancy is a significant negative life event associated with grief comparable to the grief after a peri- or neonatal death. Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to have children. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth.
42% of the women referred to RPL Unit in Rigshospitalet has a high stress level where as it's 22% in the background population trying to achieve parenthood. It's also known that 8,8% of RPL patients have a depression at referral where as it's 2,2 % in the background population trying to achieve parenthood.
This study will investigate if a 7 weeks course in meditation and mindfulness is a useful tool to reduce stress and the psychological consequences for women and their partner treated in RPL Unit in Rigshospitalet, Copenhagen.
Furthermore this study will investigate if there's a marital benefit from practicing meditation and mindfulness. The investigators will use four different scales to measure the participants stress, depression, marital benefit and fertility stress. Also the investigators will measure the participants before and after the intervention and 12 months after.
All participants will have to complete:
- Major Depression Index, a validated self-rating depression scale, which is used both clinically and in epidemiological studie. The 6-point Likert scale ranges from 0 (no depression) to 50 (extreme depression).
- Perceived Stress Scale, which is a validated 10-item-self-reporting scale for stress symptoms. The 5 point Likert scale ranges from 0 (no stress) to 40 (extreme stress).
- The COMPI Fertility Problem Stress Scale, a validated scale measuring the impact of RPL on the woman and her interpersonal relationships.
- The COMPI Marital Benefit Scale measuring if RPL has reinforced the couples mariage/relationship.
The investigators assume that meditation and mindfulness can improve the quality of life for the RPL patients and their coping strategies. It's the investigators purpose to contribute with new knowledge in this area for current and future patients.
The RPL Unit in Rigshospitalet doesn't have any psychological support apart from ordinary attention from the nurses. This study has the potential to establish mental health support as a supplement to the medical and clinical treatment for RPL patients, which is in high demand.
- Conditions
- Recurrent Pregnancy Loss
- Being tested
- Meditation and mindfulness
- Keywords
- Meditation, mindfulness, pregnancy loss, stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation and mindfulnessBehavioural
Women in the intervention arm will 3 times receive a three hours work shop with introduction to meditation and mindfulness over a 7 week period from a certified meditation instructor. Questionnaires before and after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Meditation and mindfulness intervention | Active comparator | Women in the intervention arm will 3 times receive a three hours work shop with introduction to meditation and mindfulness over a 7 week period from a certified meditation instructor. Questionnaires before and after the intervention. Receives: Behavioral: Meditation and mindfulness |
| Control group | No intervention | Women in the no intervention arm will receive no introduction to meditation and mindfulness - only questionnaires at the same time as the intervention group receives questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS)
Change from baseline to 7 weeks after date of first course day measured by Perceived Stress Scale. PSS is a validated 10-item-self-reporting scale for stress symptoms. The 5 point Likert scale ranges from 0 (no stress) to 40 (extreme stress). The higher score the more stress.
Measured: 7 weeks
Perceived Stress Scale (PSS)
Change from baseline to 12 months after date of first course day measured by the Perceived Stress Scale. PSS is a validated 10-item-self-reporting scale for stress symptoms. The 5 point Likert scale ranges from 0 (no stress) to 40 (extreme stress). The higher score the more stress.
Measured: 12 months
Secondary outcomes (5)
COMPI Fertility Problem Stress Scale
Change from baseline to 7 weeks after date of first course day using the COMPI Fertility Problem Stress Scale.
The COMPI Fertility Problem Stress Scale is a validated scale measuring the impact of RPL on the woman and her interpersonal relationships. Two questions asking if the experience of RPL has been stressful for the woman with five answering options. Followed by seven sub questions asking how big a load RPL has been for the patients interpersonal life with four answering options. The lower the score the higher stress.
Measured: 7 weeks
Marital Benefit Scale
Change in marital benefit from baseline to 7 weeks after date of first course day using the COMPI Marital Benefit Scale.
The COMPI Marital Benefit Scale has two questions asking what the RPL have mattered for their relationship/mariage:
Five options to answer: totally disagree, partly disagree, neither agree or disagree, partly agree, totally agree. Answering "Totally agree" on both questions is defined as a high marital benefit.
Measured: 7 weeks
COMPI Fertility Problem Stress Scale
Change in fertility problem stress from baseline to 12 months after date of first course day using the COMPI Fertility Problem Stress Scale.
The COMPI Fertility Problem Stress Scale is a validated scale measuring the impact of RPL on the woman and her interpersonal relationships. Two questions used to assess how big a impact RPL has for the patient with five answering options. Followed by seven sub questions asking how big a load RPL has been for the patients interpersonal life with four answering options. The lower the score the higher stress.
Measured: 12 months
Marital Benefit
Change in marital benefit from baseline to 12 months after date of first course day using the COMPI Marital Benefit Scale.
The COMPI Marital Benefit Scale has two questions asking what the RPL have mattered for their relationship/mariage:
Five options to answer: totally disagree, partly disagree, neither agree or disagree, partly agree, totally agree. Answering "Totally agree" on both questions is defined as a high marital benefit.
Measured: 12 months
Major Depression Index (MDI)
Change in depression score from baseline to 12 months after date of first course day. Major Depression Index is a validated self-rating depression scale, which is used both clinically and in epidemiological studie. The 6-point Likert scale ranges from 0 (no depression) to 50 (extreme depression).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start2 Feb 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy LossStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized trial where women in an experimental arm will receive 3 times a three hour work shop with introduction to meditation and mindfulness during a 7 week period. Women in the other arm will have no intervention.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henriette Svarre Nielsen, MD, DMSc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henriette Svarre Nielsen, MD, DMSc, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Karen Kirchheiner Jensen, Nurse, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905395
- Sponsor's protocol ID
- H-18038456
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2019
- Last updated
- 5 Apr 2019
- 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 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation and Mindfulness for Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT03905395
- Acronym / sponsor ID
- H-18038456
- Conditions
- Recurrent Pregnancy Loss
- Keywords
- Meditation, mindfulness, pregnancy loss, stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Henriette Svarre Nielsen, MD, DMScUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 5 Apr 2019 (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.
In the Danish Recurrent Pregnancy Loss Unit in Rigshospitalet in Copenhagen recurrent pregnancy loss (RPL) is defined as three og more consecutive pregnancy losses in accordance with current European guidelines.
RPL affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth.
42% of the women referred to RPL Unit in Rigshospitalet has a high stress level where as it's 22% in the background population trying to achieve parenthood. It's also known that 8,8 % of RPL patients have a depression at referral where as it's 2,2 % in the background population trying to achieve parenthood.
The study is a RCT including 62 patients - 31 in each arm. One arm will be taught in meditation and mindfulness three courses over a 7 week period. This group will also do meditation every day for 7 weeks. The other arm will have no intervention.
This study will investigate if a 7 weeks course in meditation and mindfulness is a useful tool to reduce stress and the psychological consequences for women and their partner treated in RPL Unit in Rigshospitalet, Copenhagen. Furthermore this study will investigate if there's a marital benefit such as reinforcement in their relationsship from practicing meditation and mindfulness.
There is no previous study that has investigated meditation and mindfulness for RPL.
This study has the potential to establish mental health support as a supplement to the medical and clinical treatment for RPL patients.
Detailed description
The loss of a desired pregnancy is a significant negative life event associated with grief comparable to the grief after a peri- or neonatal death. Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to have children. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth.
42% of the women referred to RPL Unit in Rigshospitalet has a high stress level where as it's 22% in the background population trying to achieve parenthood. It's also known that 8,8% of RPL patients have a depression at referral where as it's 2,2 % in the background population trying to achieve parenthood.
This study will investigate if a 7 weeks course in meditation and mindfulness is a useful tool to reduce stress and the psychological consequences for women and their partner treated in RPL Unit in Rigshospitalet, Copenhagen.
Furthermore this study will investigate if there's a marital benefit from practicing meditation and mindfulness. The investigators will use four different scales to measure the participants stress, depression, marital benefit and fertility stress. Also the investigators will measure the participants before and after the intervention and 12 months after.
All participants will have to complete:
- Major Depression Index, a validated self-rating depression scale, which is used both clinically and in epidemiological studie. The 6-point Likert scale ranges from 0 (no depression) to 50 (extreme depression).
- Perceived Stress Scale, which is a validated 10-item-self-reporting scale for stress symptoms. The 5 point Likert scale ranges from 0 (no stress) to 40 (extreme stress).
- The COMPI Fertility Problem Stress Scale, a validated scale measuring the impact of RPL on the woman and her interpersonal relationships.
- The COMPI Marital Benefit Scale measuring if RPL has reinforced the couples mariage/relationship.
The investigators assume that meditation and mindfulness can improve the quality of life for the RPL patients and their coping strategies. It's the investigators purpose to contribute with new knowledge in this area for current and future patients.
The RPL Unit in Rigshospitalet doesn't have any psychological support apart from ordinary attention from the nurses. This study has the potential to establish mental health support as a supplement to the medical and clinical treatment for RPL patients, which is in high demand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized trial where women in an experimental arm will receive 3 times a three hour work shop with introduction to meditation and mindfulness during a 7 week period. Women in the other arm will have no intervention.
| Arm | Type | Receives |
|---|---|---|
| Meditation and mindfulness intervention | Active comparator | Behavioral: Meditation and mindfulnessWomen in the intervention arm will 3 times receive a three hours work shop with introduction to meditation and mindfulness over a 7 week period from a certified meditation instructor. Questionnaires before and after the intervention. |
| Control group | No intervention | –Women in the no intervention arm will receive no introduction to meditation and mindfulness - only questionnaires at the same time as the intervention group receives questionnaires. |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with RPL
- Speaking, reading and understanding Danish
- Have given a written consent
- Have a male partner
- Have a stress score > 16 points on Perceived Stress Scale
Key exclusion criteria (4 listed)
- If the patient is pregnant on inclusion day
- If the patient already is practing meditation and mindfulness
- If the patient has a depression
- If the patient develops a depression after inclusion in either arm
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 |
|---|---|---|
| Meditation and mindfulnessWomen in the intervention arm will 3 times receive a three hours work shop with introduction to meditation and mindfulness over a 7 week period from a certified meditation instructor. Questionnaires before and after the intervention. | Behavioural | Meditation and mindfulness intervention |
Primary outcome
Perceived Stress Scale (PSS)
Time frame: 7 weeks
Change from baseline to 7 weeks after date of first course day measured by Perceived Stress Scale. PSS is a validated 10-item-self-reporting scale for stress symptoms. The 5 point Likert scale ranges from 0 (no stress) to 40 (extreme stress). The higher score the more stress.
Perceived Stress Scale (PSS)
Time frame: 12 months
Change from baseline to 12 months after date of first course day measured by the Perceived Stress Scale. PSS is a validated 10-item-self-reporting scale for stress symptoms. The 5 point Likert scale ranges from 0 (no stress) to 40 (extreme stress). The higher score the more stress.
5 secondary outcomes
COMPI Fertility Problem Stress Scale
Time frame: 7 weeks
Marital Benefit Scale
Time frame: 7 weeks
COMPI Fertility Problem Stress Scale
Time frame: 12 months
Marital Benefit
Time frame: 12 months
Major Depression Index (MDI)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Recurrent Pregnancy Loss
Recruiting
High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety
Recurrent Pregnancy Loss(RPL), Anxiety
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 1
Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma
Active, not recruitingObservational study
Fertility, Hypercoagulability, and Inflammation (FREYA) Registry
Thrombophilia
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.
Karen Kirchheiner Jensen, Nurse study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation and mindfulness in people with Recurrent Pregnancy Loss, run by Henriette Svarre Nielsen, MD, DMSc 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henriette Svarre Nielsen, MD, DMSc (+4535458486, Henriette.Svarre.Nielsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS) (time frame: 7 weeks). 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 5 Apr 2019.