Structured Contraceptive Counseling During Pregnancy

NCT ID: NCT05550064

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-19

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Contraception Intrauterine Device Contraceptive Implant Long-acting Reversible Contraception Counseling

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pregnant women will receive an intervention for structured contraceptive counseling from participating clinics. Follow-up will be through e-surveys at 6, 12, 18, and 24 months postpartum
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention arm

Evidence-based intervention for SCC, previously evaluated in a cluster randomized trial (doi:10.1111/1471-0528.16754) The intervention for prepartum SCC will consist of four different parts, adjusted to suit pregnant women with emphasis on immediate start when applicable:

1. An educational video presenting available contraceptive methods
2. 4 Key questions concerning how to deal with a new pregnancy, reproductive life plan, and additional health benefits from using contraception.
3. A tiered effectiveness chart of available contraceptives
4. A box of contraceptive models

Group Type EXPERIMENTAL

Structured contraceptive counseling

Intervention Type OTHER

1. 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.
2. The four key questions are to be asked to all pregnant women to make them reflect on factors that highly affects choice of contraceptives.
3. 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
4. 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.

Interventions

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Structured contraceptive counseling

1. 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.
2. The four key questions are to be asked to all pregnant women to make them reflect on factors that highly affects choice of contraceptives.
3. 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
4. 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dalarna University

OTHER

Sponsor Role lead

Responsible Party

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Niklas Envall

PhD, RNM, Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Niklas Envall, PhD

Role: PRINCIPAL_INVESTIGATOR

Dalarna University

Locations

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Health Care Region Dalarna

Falun, , Sweden

Site Status RECRUITING

Health Care Region Värmland

Karlstad, , Sweden

Site Status RECRUITING

Health Care Region Örebro Län

Örebro, , Sweden

Site Status RECRUITING

Health Care Region Uppsala

Uppsala, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Niklas Envall, PhD

Role: CONTACT

+46704090925

Facility Contacts

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Sara Hogmark, MD

Role: primary

Karin Ängeby, PhD

Role: primary

Yvonne Skogsdal, PhD

Role: primary

Lena Axén, RNM

Role: primary

Other Identifiers

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SPR1

Identifier Type: -

Identifier Source: org_study_id

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