Structured Contraceptive Counseling During Pregnancy

Sponsor
Dalarna University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05550064
Collaborator
(none)
160
4
1
39
40
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Structured contraceptive counseling
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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 postpartumPregnant 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
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluating Effects of Prepartum Structured Contraceptive Counseling to Increase Postpartum Use of Long-acting Reversible Contraception
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. New pregnancy [6, 12, 18, and 24 months postpartum]

    Categorical (yes/no)

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Health Care Region Dalarna Falun Sweden
2 Health Care Region Värmland Karlstad Sweden
3 Health Care Region Uppsala Uppsala Sweden
4 Health Care Region Örebro Län Örebro Sweden

Sponsors and Collaborators

  • Dalarna University

Investigators

  • Principal Investigator: Niklas Envall, PhD, Dalarna University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Niklas Envall, PhD, RNM, Senior Lecturer, Dalarna University
ClinicalTrials.gov Identifier:
NCT05550064
Other Study ID Numbers:
  • SPR1
First Posted:
Sep 22, 2022
Last Update Posted:
Sep 22, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2022