NCT05521646

Brief Summary

Immigrant women in Europe has reported lower use of effective contraception, higher risks of multiple births, and unintended pregnancies compared to native-born women. There is no evidence about this from a Swedish context nor about postpartum contraception. The purpose of this project is to promote equity in sexual and reproductive health (SRH) in Sweden by improving the quality of postpartum contraceptive counselling for and with immigrant women. The Swedish Pregnancy Registry (SPR) will be used to determine if there are any differences in birth spacing and associated complications when comparing immigrant and Swedish-born women. Registration of contraceptive methods in the SPR will be introduced. The IMPROVE-it project will increase the understanding of challenges to contraceptive services postpartum, and how to overcome these.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

August 25, 2022

Last Update Submit

October 7, 2022

Conditions

ContraceptionImmigrantPost Partum

Outcome Measures

Primary Outcomes (1)

  • Proportion of women who chose an effective contraceptive method, i.e. LARC or SARC, among immigrant and Swedish-born women.

    Data collection as registered in the Swedish pregnancy register at the postpartum visit within 16 weeks after giving birth.

    12 months

Secondary Outcomes (5)

  • Womens satisfaction with the contraceptive counselling provided at the postpartum visit

    12 months

  • Participants´ use of contraception (and type) at six and 12 months follow-up

    18-24 months

  • Participants´ satisfaction with the contraceptive method at six and 12 months follow-up

    18-24 months

  • Participants´ experiences of unintended pregnancy, abortion, miscarriages since the postpartum visit, at six and 12 months follow-up

    18-24 months

  • Participants´ experiences of planned pregnancy since the postpartum visit, at six and 12 months follow-up

    18-24 months

Study Arms (2)

Intervention

EXPERIMENTAL

QiC implemented

Other: Quality Improvement Collaborative

Control

NO INTERVENTION

Interventions

Quality Improvement CollaborativeOTHER

Explore if a Quality Improvement Collaborative can increase the proportion of immigrant women who choose an effective postpartum contraceptive method

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women coming for postpartum visit within 16 weeks post birth (live birth)

You may not qualify if:

  • Women who do not anticipate becoming sexually active with a male partner within six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Inst.

Stockholm, 17177, Sweden

RECRUITING

Related Publications (1)

  • Kilander H, Sorcher R, Berglundh S, Petersson K, Wangborg A, Danielsson KG, Iwarsson KE, Branden G, Thor J, Larsson EC. IMplementing best practice post-partum contraceptive services through a quality imPROVEment initiative for and with immigrant women in Sweden (IMPROVE it): a protocol for a cluster randomised control trial with a process evaluation. BMC Public Health. 2023 May 3;23(1):806. doi: 10.1186/s12889-023-15776-8.

    PMID: 37138268DERIVED

Central Study Contacts

Elin Larsson, PhD

CONTACT

+46702735609elin.larsson@ki.se

Helena Kilander, PhD

CONTACT

helena.kilander@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants do not know if they go to an intervention or control clinic
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, PhD

Study Record Dates

First Submitted

August 25, 2022

First Posted

August 30, 2022

Study Start

September 5, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2025

Last Updated

October 10, 2022

Record last verified: 2022-10

Locations

SE(1)