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

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 Overview

• Status: Completed
• Conditions: Medication Adherence; Emesis; Pregnancy Early
• Intervention / Treatment: Other: Pharmacist consultation

• Study Type: Interventional
• Enrollment (Actual): 369
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • OSlo, Norway, 0371
    • Department of Pharmacy, University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Pharmacist consultation in early pregnancy (gestation week <12)	Other: 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.
No Intervention: Control group; Standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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)	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)	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	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)	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)	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)	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	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)	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)	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)	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	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).	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).	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).	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).	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	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	1 year

Collaborators and Investigators

• Sponsor: Hedvig Marie Egeland Nordeng
• Investigators: Study Director: Henrik Schultz, Department of Pharmacy, University of Oslo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SafeStart

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available because of data protection regulation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No