Promoting Equitable Reproductive Health: Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 4,000
- Locations
- 1
- Primary Endpoint
- Proportion of women who chose an effective contraceptive method, i.e. LARC or SARC, among immigrant and Swedish-born women.
Study Overview
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.
Detailed Description
This cRCT will be conducted at MHCs in the regions of Jönköping, Västra Götaland and Stockholm. The unit of randomization will be the clinics. The Swedish pregnancy Register (SPR) will be used to collect data on the women's choice of postpartum contraceptive method, and the proportion of women choosing an effective method will be compared between control and intervention clinics. A survey will be completed for both groups at the postpartum visit at MHCs within 16 weeks postpartum to evaluate the choice of contraceptive method and the counselling received, as well as six and 12 months after the visit to determine ongoing contraceptive use and satisfaction with the method. Furthermore, the follow up at six and 12 months will identify any unintended or planned pregnancy, abortion, or miscarriage that has happened since the postpartum visit.
Inclusion criteria: Women coming for postpartum visit within 16 weeks post birth (live birth). Exclusion criteria: Women below 18 years or having had a still birth. The intervention clinics will register women's choice of contraception during the postpartum MHC visit and participate in Quality Improvement Collaboratives (QIC) for 12 months. The control clinics will provide routine care, register women's choice of contraception in the SPR. Recruitment: Both type of clinics will register women's choice of contraception in the SPR at the postpartum visit within 16 weeks after giving birth and ask women for consent to participate in the study, i.e. respond to a self-administered questionnaire during the visit and be contacted for follow-up. Main outcome: Proportion of women who chose an effective contraceptive method, i.e. LARC or SARC, among immigrant and Swedish-born women, as registered in the SPR at the postpartum visit within 16 weeks after giving birth.
Secondary outcomes:
At enrolment:
- Women's satisfaction with the contraceptive counselling
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Masking Description
The participants do not know if they go to an intervention or control clinic
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women coming for postpartum visit within 16 weeks post birth (live birth)
Exclusion Criteria
- •Women who do not anticipate becoming sexually active with a male partner within six months.
Arms & Interventions
Control
Intervention
QiC implemented
Intervention: Quality Improvement Collaborative (Other)
Outcomes
Primary Outcomes
Proportion of women who chose an effective contraceptive method, i.e. LARC or SARC, among immigrant and Swedish-born women.
Time Frame: 12 months
Data collection as registered in the Swedish pregnancy register at the postpartum visit within 16 weeks after giving birth.
Secondary Outcomes
- Participants´ use of contraception (and type) at six and 12 months follow-up(18-24 months)
- Womens satisfaction with the contraceptive counselling provided at the postpartum visit(12 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)
- Participants´ satisfaction with the contraceptive method at six and 12 months follow-up(18-24 months)
Investigators
Elin Larsson
Associate professor, PhD
Karolinska Institutet