Structured Contraceptive Counseling During Pregnancy

Contraception Clinical Trial

Official title:

Evaluating Effects of Prepartum Structured Contraceptive Counseling to Increase Postpartum Use of Long-acting Reversible Contraception

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05550064
• Other study ID #: SPR1
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Contraception
• Contraceptive Implant
• Counseling
• Intrauterine Device
• Long-acting Reversible Contraception

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