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

Background: Immigrant women’s challenges in realizing sexual and reproductive health and rights (SRHR) are exacerbated by the lack of knowledge regarding how to tailor post-partum contraceptive services to their needs. Therefore, the overall aim of the IMPROVE-it project is to promote equity in SRHR through improvement of contraceptive services with and for immigrant women, and, thus, to strengthen women’s possibility to choose and initiate effective contraceptive methods post-partum. Methods: This Quality Improvement Collaborative (QIC) on contraceptive services and use will combine a cluster randomized controlled trial (cRCT) with a process evaluation. The cRCT will be conducted at 28 maternal health clinics (MHCs) in Sweden, that are the clusters and unit of randomization, and include women attending regular post-partum visits within 16 weeks post birth. Utilizing the Breakthrough Series Collaborative model, the study’s intervention strategies include learning sessions, action periods, and workshops informed by joint learning, co-design, and evidence-based practices. The primary outcome, women’s choice of an effective contraceptive method within 16 weeks after giving birth, will be measured using the Swedish Pregnancy Register (SPR). Secondary outcomes regarding women’s experiences of contraceptive counselling, use and satisfaction of chosen contraceptive method will be evaluated using questionnaires completed by participating women at enrolment, 6 and 12 months post enrolment. The outcomes including readiness, motivation, competence and confidence will be measured through project documentation and questionnaires. The project’s primary outcome involving women’s choice of contraceptive method will be estimated by using a logistic regression analysis. A multivariate analysis will be performed to control for age, sociodemographic characteristics, and reproductive history. The process evaluation will be conducted using recordings from learning sessions, questionnaires aimed at participating midwives, intervention checklists and project documents. Discussion: The intervention’s co-design activities will meaningfully include immigrants in implementation research and allow midwives to have a direct, immediate impact on improving patient care. This study will also provide evidence as to what extent, how and why the QIC was effective in post-partum contraceptive services. Trial registration: NCT05521646, August 30, 2022