Pregnancy EarlySafeStartNCT04182750
Promoting Safe Medication Use in Pregnancy in the Era of Real-World Data - The SafeStart Study
A study testing Pharmacist consultation in people with Pregnancy Early and Emesis, run by Hedvig Marie Egeland Nordeng at 1 site in Norway.
Trial summary
The background for this project is the growing concern about women's use of medications during pregnancy. Several studies have shown that up to 80% of all pregnant women use at least one medication during pregnancy, most commonly prescription-free medications for pregnancy-related ailments. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Early, Emesis, Medication Adherence
- What is being tested?
- Pharmacist consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 1 siteNorway
- Study dates
- 6 Feb 2018to 27 Nov 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant in the first trimester (< gestational week 12)
- Speaks/understand Norwegian
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The background for this project is the growing concern about women's use of medications during pregnancy. Several studies have shown that up to 80% of all pregnant women use at least one medication during pregnancy, most commonly prescription-free medications for pregnancy-related ailments. Despite the frequent use of medications during pregnancy pregnant women tend to overestimate the teratogenic risk of medications - often resulting in unfound anxiety, non-adherence to needed medication, use of herbal "natural" medications, and in the worst case, termination of otherwise wanted pregnancies. Specifically, the investigators have found that ailments such as nausea and vomiting in pregnancy (NVP), often are mismanaged, resulting in profound impacts on the women´s quality of life, but are often being neglected by healthcare personnel.
The objective of this project is to investigate whether a pharmacist consultation provided in early pregnancy can result in optimized management of pregnancy-related ailment, a higher quality of life and reduce sick leave among pregnant women. The investigators will capitalize on the existence of a unique personal identification number allocated to every citizen in Norway and link the self-reported data generated in the intervention study to five national health registries. As even mild NVP has been shown to have a huge impact on pregnant women's quality of life, the investigators will specifically focus on preventative measures for NVP.
Read more
The investigators main hypothesis is:
"A pharmacist intervention focusing on safe medication use and in early pregnancy can reduce sick leave days and rates, enhance adherence, promote better management of common pregnancy-related ailments (especially NVP), and improve pregnant women's quality of life"
The investigators will include all pregnant women in pregnancy weeks <12. Pregnant women under the age of 18, women who do not understand Norwegian and women for some other reason are unable to sign the consent form will be excluded. Women eligible for inclusion will be allocated to either the intervention group or the control group. Participants in the intervention group will be directed to the nearest study pharmacy for the intervention. The proposed study intervention is to be applied and carried out in the community pharmacy. Approximately 10-15 community pharmacists across the country will be involved. If the distance to a study pharmacy is too far for a physical meeting, the intervention will be performed over the telephone; otherwise, the private information room in the pharmacies will be utilized.
All pharmacists involved in the study will be specifically trained to perform the consultation. They will complete several e-learning modules on pharmacotherapy in pregnancy and attend a full-day training work-shop focusing on communication skills led by experienced clinical pharmacists.
Data will be collected by four online questionnaires, one at baseline in the first trimester, one during the second trimester, one during the third trimester, and the last one in the post-partum period. Participants in the intervention group will, in addition, complete a satisfaction questionnaire right after the completion of the consultation. All questionnaires will be distributed to the participants by email. Data about the participants will, in addition, be collected from five national registries; National Sick Leave Database (Forløpsdatabasen Trygd), The Norwegian Patient Registry, The Norwegian Prescription Database, The Medical Birth Registry of Norway, and the Municipality Patient and User Registry (Kommunalt Bruker- og Pasientregister). These data will be linked to the self-reported data (by the unique identification number of every citizen in Norway) collected during the intervention study.
An economic evaluation will be done to assess the cost-effectiveness of the intervention.
All study pharmacists involved in the study will be invited to participate in a qualitative interview to share their experience and opinions regarding the pharmacist intervention.
Participants enrolled in the intervention study will be invited to a qualitative interview to share their inputs and opinions on what a mobile application for self-management and an online patient-centered decision support tool for NVP should include.
- Conditions
- Pregnancy Early, Emesis, Medication Adherence
- Being tested
- Pharmacist consultation
- Medical subject headings
- Vomiting, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist consultationOther
The intervention is a patient-centered consultation that will last about 15 minutes. The intervention is defined as "A planned, individualized, and structured conversation with the purpose to relieve pregnant women for any concern and answer questions she may have regarding self-care ailments and medication use in pregnancy". Specifically, the consultation will:
- Answer any questions the participants may have within pharmaceutical care.
- Improve pregnant women's understanding of common pregnancy-related ailments and hence contribute to better management of the ailments.
- Raise awareness, provide confidence, and give information about safe medications options in pregnancy
- Focus on preventative measures for NVP.
- Contribute to better adherence for needed/chronic medication throughout the pregnancy.
The pharmacists will beforehand have access to the women´s answers from the baseline questionnaire Q1, including information about her medical conditions and medication use.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Pharmacist consultation in early pregnancy (gestation week <12) Receives: Other: Pharmacist consultation |
| Control group | No intervention | Standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life between the first and second trimester
Quality of life measured by the Quality of Life Scale (QOLS) which ranges from 16 to 112, where higher score indicates better quality of life
Measured: Change in quality of life between the first (gestation week < 12) and second trimester (between gestation week 17 and 25)
Sick leave during the first trimester
Self-reported sick leave rate and days and as recorded in the national registry (Forløpsdatabasen Trygd) during the first trimester (up to weeks 12)
Measured: Up to weeks 12
Sick leave during the second trimester
Self-reported sick leave rate and days and as recorded in the national registry (Forløpsdatabasen Trygd) during the second trimester (between weeks 13 and 28)
Measured: Between weeks 13 and 28
Sick leave during the third trimester
Self-reported sick leave rate and days and as recorded in the national registry (Forløpsdatabasen Trygd) during the third trimester (between weeks 19 and delivery)
Measured: Between weeks 29 and delivery
Sick leave in the post-partum period
Self-reported sick leave rate and days and as recorded in the national registry (Forløpsdatabasen Trygd) from delivery and up to three months post-partum
Measured: From delivery and up to three months post-partum
Utilization of health care services during the first trimester
Self-reported number of visits and as recorded in the Norwegian Patient Registry during the first trimester (up to weeks 12)
Measured: Up to weeks 12
Utilization of health care services during the second trimester
Self-reported number of visits and as recorded in the Norwegian Patient Registry during the second trimester (between weeks 13 and 28)
Measured: Between weeks 13 and 28
Utilization of health care services during the third trimester
Self-reported number of visits and as recorded in the Norwegian Patient Registry during the third trimester (between weeks 29 and delivery)
Measured: Between weeks 29 and delivery
Utilization of health care services in the post-partum period
Self-reported number of visits and as recorded in the Norwegian Patient Registry from delivery and up to three months post-partum
Measured: From delivery and up to three months post-partum.
Use of medications during the first trimester
Self-reported medication use and as recorded in the Norwegian Prescription Database during the first trimester (up to weeks 12)
Measured: Up to weeks 12
Use of medications during the second trimester
Self-reported medication use and as recorded in the Norwegian Prescription Database during the second trimester (between weeks 13 and 28)
Measured: Between weeks 13 and 28
Use of medications during the third trimester
Self-reported medication use and as recorded in the Norwegian Prescription Database during the third trimester (between weeks 29 and delivery)
Measured: Between weeks 29 and delivery
Use of medications in the post-partum period
Self-reported medication use and as recorded in the Norwegian Prescription Database from delivery and up to three months post-partum
Measured: From delivery and and up to three months post-partum.
Quality-Adjusted-Life-Years (QALY) during the first trimester
Participants' Quality-Adjusted-Life-Years (QALYs) measured by the EuroQoL health-related quality of life instrument (EQ-5D-5L) during the first trimester. The EQ-5D-5L state will be converted to an index value (based on the most appropriate weights available for the Norwegian population) and further to QALYs. QALYs ranges from 0 (death) to 1 (full or optimal health).
Measured: Up to weeks 12
Quality-Adjusted-Life-Years (QALY) during the second trimester
Participants' Quality-Adjusted-Life-Years (QALY) measured by the EuroQoL health-related quality of life instrument (EQ-5D-5L) during the second trimester. The EQ-5D-5L state will be converted to an index value (based on the most appropriate weights available for the Norwegian population) and further to QALYs. QALYs ranges from 0 (death) to 1 (full or optimal health).
Measured: Between weeks 13 and 28
Quality-Adjusted-Life-Years (QALY) during the third trimester
Participants' Quality-Adjusted-Life-Years (QALY) measured by the EuroQoL health-related quality of life instrument (EQ-5D-5L) during the third trimester. The EQ-5D-5L state will be converted to an index value (based on the most appropriate weights available for the Norwegian population) and further to QALYs. QALYs ranges from 0 (death) to 1 (full or optimal health).
Measured: Between weeks 29 and delivery
Quality-Adjusted-Life-Years (QALY) in the post-partum period
Participants' Quality-Adjusted-Life-Years (QALY) measured by the EuroQoL health-related quality of life instrument (EQ-5D-5L) from delivery and up to three months post-partum. The EQ-5D-5L state will be converted to an index value (based on the most appropriate weights available for the Norwegian population) and further to QALYs. QALYs ranges from 0 (death) to 1 (full or optimal health).
Measured: Between delivery and up to three months post-partum
Economic evaluation of the intervention
All costs related to performing the intervention, reported by the study pharmacists
Measured: After intervention completion (up to weeks 12)
Economic evaluation of the intervention
Cost related to sick leave as recorded in the national registry Forløpsdatabasen Trygd during pregnancy and up to three months post-partum
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start6 Feb 2018
- Primary completion31 Oct 2021
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hedvig Marie Egeland Nordeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hedvig Marie Egeland Nordeng, University of Oslo
- Investigators
- Henrik Schultz, Study director, Department of Pharmacy, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182750
- Sponsor's protocol ID
- SafeStart
- Acronym
- SafeStart
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2019
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available because of data protection regulation.
Publications
Ngo E, Truong MB, Nordeng H. Impact of a primary care pharmacist consultations on pregnant women's medication use: the SafeStart intervention study linked to a national prescription database. Int J Clin Pharm. 2023 Aug;45(4):893-902. doi: 10.1007/s11096-023-01577-x. Epub 2023 May 8.
PubMed 37156960Truong MB, Ngo E, Ariansen H, Tsuyuki RT, Nordeng H. The effect of a pharmacist consultation on pregnant women's quality of life with a special focus on nausea and vomiting: an intervention study. BMC Pregnancy Childbirth. 2020 Dec 9;20(1):766. doi: 10.1186/s12884-020-03472-z.
PubMed 33298010
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Safe Medication Use in Pregnancy in the Era of Real-World Data - The SafeStart Study
- ClinicalTrials.gov ID
- NCT04182750
- Acronym / sponsor ID
- SafeStart / SafeStart
- Conditions
- Pregnancy Early, Emesis, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Hedvig Marie Egeland NordengUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 2 Dec 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.
The background for this project is the growing concern about women's use of medications during pregnancy. Several studies have shown that up to 80% of all pregnant women use at least one medication during pregnancy, most commonly prescription-free medications for pregnancy-related ailments. Despite the frequent use of medications during pregnancy pregnant women tend to overestimate the teratogenic risk of medications - often resulting in unfound anxiety, non-adherence to needed medication, use of herbal "natural" medications, and in the worst case, termination of otherwise wanted pregnancies. Specifically, the investigators have found that ailments such as nausea and vomiting in pregnancy (NVP), often are mismanaged, resulting in profound impacts on the women´s quality of life, but are often being neglected by healthcare personnel.
The objective of this project is to investigate whether a pharmacist consultation provided in early pregnancy can result in optimized management of pregnancy-related ailment, a higher quality of life and reduce sick leave among pregnant women. The investigators will capitalize on the existence of a unique personal identification number allocated to every citizen in Norway and link the self-reported data generated in the intervention study to five national health registries. As even mild NVP has been shown to have a huge impact on pregnant women's quality of life, the investigators will specifically focus on preventative measures for NVP.
The investigators main hypothesis is:
"A pharmacist intervention focusing on safe medication use and in early pregnancy can reduce sick leave days and rates, enhance adherence, promote better management of common pregnancy-related ailments (especially NVP), and improve pregnant women's quality of life"
The investigators will include all pregnant women in pregnancy weeks <12. Pregnant women under the age of 18, women who do not understand Norwegian and women for some other reason are unable to sign the consent form will be excluded. Women eligible for inclusion will be allocated to either the intervention group or the control group. Participants in the intervention group will be directed to the nearest study pharmacy for the intervention. The proposed study intervention is to be applied and carried out in the community pharmacy. Approximately 10-15 community pharmacists across the country will be involved. If the distance to a study pharmacy is too far for a physical meeting, the intervention will be performed over the telephone; otherwise, the private information room in the pharmacies will be utilized.
All pharmacists involved in the study will be specifically trained to perform the consultation. They will complete several e-learning modules on pharmacotherapy in pregnancy and attend a full-day training work-shop focusing on communication skills led by experienced clinical pharmacists.
Data will be collected by four online questionnaires, one at baseline in the first trimester, one during the second trimester, one during the third trimester, and the last one in the post-partum period. Participants in the intervention group will, in addition, complete a satisfaction questionnaire right after the completion of the consultation. All questionnaires will be distributed to the participants by email. Data about the participants will, in addition, be collected from five national registries; National Sick Leave Database (Forløpsdatabasen Trygd), The Norwegian Patient Registry, The Norwegian Prescription Database, The Medical Birth Registry of Norway, and the Municipality Patient and User Registry (Kommunalt Bruker- og Pasientregister). These data will be linked to the self-reported data (by the unique identification number of every citizen in Norway) collected during the intervention study.
An economic evaluation will be done to assess the cost-effectiveness of the intervention.
All study pharmacists involved in the study will be invited to participate in a qualitative interview to share their experience and opinions regarding the pharmacist intervention.
Participants enrolled in the intervention study will be invited to a qualitative interview to share their inputs and opinions on what a mobile application for self-management and an online patient-centered decision support tool for NVP should include.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Pharmacist consultationPharmacist consultation in early pregnancy (gestation week <12) |
| Control group | No intervention | –Standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant in the first trimester (< gestational week 12)
- Speaks/understand Norwegian
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Pharmacist consultationThe intervention is a patient-centered consultation that will last about 15 minutes. The intervention is defined as "A planned, individualized, and structured conversation with the purpose to relieve pregnant women for any concern and answer questions she may have regarding self-care ailments and medication use in pregnancy". Specifically, the consultation will: * Answer any questions the participants may have within pharmaceutical care. * Improve pregnant women's understanding of common pregnancy-related ailments and hence contribute to better management of the ailments. * Raise awareness, provide confidence, and give information about safe medications options in pregnancy * Focus on preventative measures for NVP. * Contribute to better adherence for needed/chronic medication throughout the pregnancy. The pharmacists will beforehand have access to the women´s answers from the baseline questionnaire Q1, including information about her medical conditions and medication use. | Other | Intervention group |
Primary outcome
Change in quality of life between the first and second trimester
Time frame: Change in quality of life between the first (gestation week < 12) and second trimester (between gestation week 17 and 25)
Quality of life measured by the Quality of Life Scale (QOLS) which ranges from 16 to 112, where higher score indicates better quality of life
Sick leave during the first trimester
Time frame: Up to weeks 12
Self-reported sick leave rate and days and as recorded in the national registry (Forløpsdatabasen Trygd) during the first trimester (up to weeks 12)
Sick leave during the second trimester
Time frame: Between weeks 13 and 28
Self-reported sick leave rate and days and as recorded in the national registry (Forløpsdatabasen Trygd) during the second trimester (between weeks 13 and 28)
Sick leave during the third trimester
Time frame: Between weeks 29 and delivery
Self-reported sick leave rate and days and as recorded in the national registry (Forløpsdatabasen Trygd) during the third trimester (between weeks 19 and delivery)
Sick leave in the post-partum period
Time frame: From delivery and up to three months post-partum
Self-reported sick leave rate and days and as recorded in the national registry (Forløpsdatabasen Trygd) from delivery and up to three months post-partum
Utilization of health care services during the first trimester
Time frame: Up to weeks 12
Self-reported number of visits and as recorded in the Norwegian Patient Registry during the first trimester (up to weeks 12)
Utilization of health care services during the second trimester
Time frame: Between weeks 13 and 28
Self-reported number of visits and as recorded in the Norwegian Patient Registry during the second trimester (between weeks 13 and 28)
Utilization of health care services during the third trimester
Time frame: Between weeks 29 and delivery
Self-reported number of visits and as recorded in the Norwegian Patient Registry during the third trimester (between weeks 29 and delivery)
Utilization of health care services in the post-partum period
Time frame: From delivery and up to three months post-partum.
Self-reported number of visits and as recorded in the Norwegian Patient Registry from delivery and up to three months post-partum
Use of medications during the first trimester
Time frame: Up to weeks 12
Self-reported medication use and as recorded in the Norwegian Prescription Database during the first trimester (up to weeks 12)
Use of medications during the second trimester
Time frame: Between weeks 13 and 28
Self-reported medication use and as recorded in the Norwegian Prescription Database during the second trimester (between weeks 13 and 28)
Use of medications during the third trimester
Time frame: Between weeks 29 and delivery
Self-reported medication use and as recorded in the Norwegian Prescription Database during the third trimester (between weeks 29 and delivery)
Use of medications in the post-partum period
Time frame: From delivery and and up to three months post-partum.
Self-reported medication use and as recorded in the Norwegian Prescription Database from delivery and up to three months post-partum
Quality-Adjusted-Life-Years (QALY) during the first trimester
Time frame: Up to weeks 12
Participants' Quality-Adjusted-Life-Years (QALYs) measured by the EuroQoL health-related quality of life instrument (EQ-5D-5L) during the first trimester. The EQ-5D-5L state will be converted to an index value (based on the most appropriate weights available for the Norwegian population) and further to QALYs. QALYs ranges from 0 (death) to 1 (full or optimal health).
Quality-Adjusted-Life-Years (QALY) during the second trimester
Time frame: Between weeks 13 and 28
Participants' Quality-Adjusted-Life-Years (QALY) measured by the EuroQoL health-related quality of life instrument (EQ-5D-5L) during the second trimester. The EQ-5D-5L state will be converted to an index value (based on the most appropriate weights available for the Norwegian population) and further to QALYs. QALYs ranges from 0 (death) to 1 (full or optimal health).
Quality-Adjusted-Life-Years (QALY) during the third trimester
Time frame: Between weeks 29 and delivery
Participants' Quality-Adjusted-Life-Years (QALY) measured by the EuroQoL health-related quality of life instrument (EQ-5D-5L) during the third trimester. The EQ-5D-5L state will be converted to an index value (based on the most appropriate weights available for the Norwegian population) and further to QALYs. QALYs ranges from 0 (death) to 1 (full or optimal health).
Quality-Adjusted-Life-Years (QALY) in the post-partum period
Time frame: Between delivery and up to three months post-partum
Participants' Quality-Adjusted-Life-Years (QALY) measured by the EuroQoL health-related quality of life instrument (EQ-5D-5L) from delivery and up to three months post-partum. The EQ-5D-5L state will be converted to an index value (based on the most appropriate weights available for the Norwegian population) and further to QALYs. QALYs ranges from 0 (death) to 1 (full or optimal health).
Economic evaluation of the intervention
Time frame: After intervention completion (up to weeks 12)
All costs related to performing the intervention, reported by the study pharmacists
Economic evaluation of the intervention
Time frame: 1 year
Cost related to sick leave as recorded in the national registry Forløpsdatabasen Trygd during pregnancy and up to three months post-partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 37156960Ngo E, Truong MB, Nordeng H. Impact of a primary care pharmacist consultations on pregnant women's medication use: the SafeStart intervention study linked to a national prescription database. Int J Clin Pharm. 2023 Aug;45(4):893-902. doi: 10.1007/s11096-023-01577-x. Epub 2023 May 8.
- Derived from this study: PubMed 33298010Truong MB, Ngo E, Ariansen H, Tsuyuki RT, Nordeng H. The effect of a pharmacist consultation on pregnant women's quality of life with a special focus on nausea and vomiting: an intervention study. BMC Pregnancy Childbirth. 2020 Dec 9;20(1):766. doi: 10.1186/s12884-020-03472-z.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available because of data protection regulation.
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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.
Henrik Schultz study director
Department of Pharmacy, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist consultation in people with Pregnancy Early and Emesis, run by Hedvig Marie Egeland Nordeng at 1 site in Norway.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 28 Nov 2023. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in quality of life between the first and second trimester (time frame: Change in quality of life between the first (gestation week < 12) and second trimester (between gestation week 17 and 25)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04182750, which also lists 2 linked publications.
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 28 Nov 2023.