Clinical trial NCT04182750: Promoting Safe Medication Use in Pregnancy in the Era of Real-World Data - The SafeStart Study
Official title: Promoting Safe Medication Use in Pregnancy in the Era of Real-World Data - The SafeStart Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Early
Emesis
Medication Adherence
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 369
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Pregnant in the first trimester (\< gestational week 12)
* Speaks/understand Norwegian

Exclusion Criteria:

Primary outcomes:
measure: Change in quality of life between the first and second trimester
timeFrame: Change in quality of life between the first (gestation week < 12) and second trimester (between gestation week 17 and 25)
measure: Sick leave during the first trimester
timeFrame: Up to weeks 12
measure: Sick leave during the second trimester
timeFrame: Between weeks 13 and 28
measure: Sick leave during the third trimester
timeFrame: Between weeks 29 and delivery
measure: Sick leave in the post-partum period
timeFrame: From delivery and up to three months post-partum
measure: Utilization of health care services during the first trimester
timeFrame: Up to weeks 12
measure: Utilization of health care services during the second trimester
timeFrame: Between weeks 13 and 28
measure: Utilization of health care services during the third trimester
timeFrame: Between weeks 29 and delivery
measure: Utilization of health care services in the post-partum period
timeFrame: From delivery and up to three months post-partum.
measure: Use of medications during the first trimester
timeFrame: Up to weeks 12
measure: Use of medications during the second trimester
timeFrame: Between weeks 13 and 28
measure: Use of medications during the third trimester
timeFrame: Between weeks 29 and delivery
measure: Use of medications in the post-partum period
timeFrame: From delivery and and up to three months post-partum.
measure: Quality-Adjusted-Life-Years (QALY) during the first trimester
timeFrame: Up to weeks 12
measure: Quality-Adjusted-Life-Years (QALY) during the second trimester
timeFrame: Between weeks 13 and 28
measure: Quality-Adjusted-Life-Years (QALY) during the third trimester
timeFrame: Between weeks 29 and delivery
measure: Quality-Adjusted-Life-Years (QALY) in the post-partum period
timeFrame: Between delivery and up to three months post-partum
measure: Economic evaluation of the intervention
timeFrame: After intervention completion (up to weeks 12)
measure: Economic evaluation of the intervention
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: OSlo
country: Norway
facility: Department of Pharmacy, University of Oslo
Study officials:
affiliation: Department of Pharmacy, University of Oslo
name: Henrik Schultz
role: STUDY_DIRECTOR
References:
citation: Truong 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.