Structured Contraceptive Counseling During Pregnancy

NCT05550064 | Recruiting

• 1 other identifier: SPR1
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• New pregnancy

  6, 12, 18, and 24 months postpartum

• Outcome of new pregnancy

  6, 12, 18, nd 24 months postpartum

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Other: Structured contraceptive counseling

Interventions

Structured contraceptive counseling 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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older, gestational week 30 or more, need for contraception 6 months or more after delivery

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Dalarna University: lead

Study Sites (4)

Health Care Region Dalarna

Falun, Sweden

RECRUITING

Health Care Region Värmland

Karlstad, Sweden

RECRUITING

Health Care Region Örebro Län

Örebro, Sweden

RECRUITING

Health Care Region Uppsala

Uppsala, Sweden

RECRUITING

Study Officials

• Niklas Envall, PhD

  Dalarna University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niklas Envall, PhD

CONTACT

+46704090925; nen@du.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RNM, Senior Lecturer

Model Details: 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

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 22, 2022
• Study Start: November 19, 2022
• Primary Completion: June 19, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

SE (4)