Structured Contraceptive Counseling During Pregnancy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Contraception; Contraceptive Implant; Counseling; Intrauterine Device; Long-acting Reversible Contraception
• Intervention / Treatment: Other: Structured contraceptive counseling

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Niklas Envall, PhD; Phone Number: +46704090925; Email: nen@du.se

Study Locations

• Sweden
  • Falun, Sweden
    • Recruiting
    • Health Care Region Dalarna
    • Contact: Sara Hogmark, MD
  • Karlstad, Sweden
    • Recruiting
    • Health Care Region Värmland
    • Contact: Karin Ängeby, PhD
  • Uppsala, Sweden
    • Recruiting
    • Health Care Region Uppsala
    • Contact: Lena Axén, RNM
  • Örebro, Sweden
    • Recruiting
    • Health Care Region Örebro Län
    • Contact: Yvonne Skogsdal, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
New pregnancy	Categorical (yes/no)	6, 12, 18, and 24 months postpartum
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

Collaborators and Investigators

• Sponsor: Dalarna University
• Investigators: Principal Investigator: Niklas Envall, PhD, Dalarna University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents
• Other Study ID Numbers: SPR1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request, de-identified data might be shared with other researchers that share the purpose of this trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No