Promoting Safe Medication Use in Pregnancy in the Era of Real-World Data - The SafeStart Study

NCT ID: NCT04182750

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 369 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-06
• Study Completion Date: 2023-11-27

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.

Conditions

Pregnancy Early; Emesis; Medication Adherence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention group

Pharmacist consultation in early pregnancy (gestation week \<12)

Group Type: EXPERIMENTAL

Pharmacist consultation

Intervention Type: OTHER

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.

Control group

Standard care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pharmacist consultation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hedvig Marie Egeland Nordeng

OTHER

Sponsor Role: lead

Responsible Party

Hedvig Marie Egeland Nordeng

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Henrik Schultz

Role: STUDY_DIRECTOR

Department of Pharmacy, University of Oslo

Locations

Department of Pharmacy, University of Oslo

Oslo, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 37156960 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33298010 (View on PubMed)

Other Identifiers

SafeStart

Identifier Type: -

Identifier Source: org_study_id