Impact of the Microbiome on Time to Pregnancy and Pregnancy Outcomes in Fertile Women Attempting to Conceive
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed.
研究概览
简要总结
This study aims to investigate the microbiome of women with previously proven fertility who plan to become pregnant.
详细描述
The women will be recruited at the time of removal of a copper or hormonal intrauterine device (IUD) or removal of a contraceptive implant at the barnmorskemottagningar (midwife clinics) in Stockholm's county in Sweden. A total of 500 women will be included in the study and will be followed until conception or up to the end of 1 year, whichever comes first. If conception occurs, the woman will be followed throughout pregnancy. Participant recruitment will take place over a period of two years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a previous live birth in the past 5 years and planning a new pregnancy with the same male partner.
- •18-40 years of age
- •Swedish personal identity number and a Swedish address (to send a sampling self-kit)
- •Sufficient understanding of spoken and written Swedish or English to provide informed consent and complete the web-based questionnaire.
排除标准
- •Women who do not have a child yet and plan to cease their contraception.
结局指标
主要结局
The microbiome profile and metabolome associated with time to pregnancy, miscarriage, and live birth will be assessed.
时间窗: 2024
次要结局
- Microbiome profiles and metabolome related to obstetric outcomes(2024)
- Microbiome profile for those women who don't conceive within a year.(2024)
- The metabolome of the recognized microbiome for women with normal pregnancy outcomes(2024)
- The metabolome of the recognized microbiome for women who develop miscarriage or other pregnancy complications(2024)
- The microbiome profile for women above age >38 and women below <38.(2024)
- The influence of BMI, medications and comorbidities on the microbiome profiles.(2024)
研究者
Kenny Rodriguez-Wallberg
MD, PhD, Professor
Karolinska Institutet