Structured Contraceptive Counseling During Pregnancy

Not Applicable

Recruiting

• Conditions: Contraception; Intrauterine Device; Long-acting Reversible Contraception; Contraceptive Implant; Counseling
• Interventions: Other: Structured contraceptive counseling

• Registration Number: NCT05550064
• Lead Sponsor: Dalarna University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Study Start: 2022-11-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Structured contraceptive counseling	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

Primary Outcome Measures

Name	Time	Method
Difference in proportions of LARC use 6 months postpartum among women receiving structured contraceptive counseling compared to standard care during pregnancy.	6 months post partum	Percentage

Secondary Outcome Measures

Name	Time	Method
New pregnancy	6, 12, 18, and 24 months postpartum	Categorical (yes/no)
Outcome of new pregnancy	6, 12, 18, nd 24 months postpartum	Categorical (yes/no) for planing to keep; kept; misscarriage; ectopic pregnancy; planning abortion; had an abotion

Trial Locations

Locations (4)

Health Care Region Uppsala; 🇸🇪 Uppsala, Sweden

Health Care Region Örebro Län; 🇸🇪 Örebro, Sweden

Health Care Region Dalarna; 🇸🇪 Falun, Sweden

Health Care Region Värmland; 🇸🇪 Karlstad, Sweden