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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05550064
Other study ID # SPR1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 19, 2022
Est. completion date December 2026

Study information

Verified date February 2024
Source Dalarna University
Contact Niklas Envall, PhD
Phone +46704090925
Email nen@du.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Unintended pregnancy is common among women of fertile age, and also among those who have recently given birth. A Swedish study has shown that about 7.7% experience a new pregnancy, and that 2.5% will have an abortion between 12-24 months from childbirth. This is a prospective observational intervention study, aiming to evaluate the effects of structured contraceptive counseling during pregnancy on uptake of contraception postpartum and more specifically on long-acting reversible contraceptive methods, and to identify and explore the provider's and patient's experiences of structured contraceptive counseling during pregnancy.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date December 2026
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years or older, gestational week 30 or more, need for contraception 6 months or more after delivery Exclusion Criteria: - Language barrier that affects participation when an interpreter is not available, assisted fertilization, planned sterilization of partner, use of contraception for other purposes than pregnancy prevention.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Structured contraceptive counseling
Educational video - healthcare providers (Medical doctors and nurse-midwives)present available contraceptives that could be used after delivery, with emphasis on effectiveness, how they should be used, mechanism of action and health benefits. The four key questions are to be asked to all pregnant women to make them reflect on factors that highly affects choice of contraceptives. A tiered effectiveness chart will be used to visualize the effectiveness of different contraceptives, and guide the prospective user in her choice depending on the answers to the key questions The box of contraceptive models are used for the prospective user to inspect, hold, feel the different contraceptives, as this has been shown to decrease fear regarding specific methods.

Locations

Country Name City State
Sweden Health Care Region Dalarna Falun
Sweden Health Care Region Värmland Karlstad
Sweden Health Care Region Örebro Län Örebro
Sweden Health Care Region Uppsala Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Dalarna University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in proportions of LARC use 6 months postpartum among women receiving structured contraceptive counseling compared to standard care during pregnancy. Percentage 6 months post partum
Secondary New pregnancy Categorical (yes/no) 6, 12, 18, and 24 months postpartum
Secondary Outcome of new pregnancy Categorical (yes/no) for planing to keep; kept; misscarriage; ectopic pregnancy; planning abortion; had an abotion 6, 12, 18, nd 24 months postpartum
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