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临床试验/NCT05521646
NCT05521646招募中不适用

Promoting Equitable Reproductive Health: Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2022年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
4,000
试验地点
2
主要终点
Proportion of women who chose an effective contraceptive method, i.e. LARC or SARC, among immigrant and Swedish-born women.

研究概览

简要总结

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.

详细描述

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:

  1. Women's satisfaction with the contraceptive counselling

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

盲法说明

The participants do not know if they go to an intervention or control clinic

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 12 months

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

次要结局

  • 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´ 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elin Larsson

Associate professor, PhD

Karolinska Institutet

研究点 (2)

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