Oxfordshire Women and Their Children's Health- A Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Recruitment feasibility
研究概览
简要总结
The aim of this feasibility study is to test recruitment of participants into Phase 1 of the study and then the re-recruitment and retention of participants in Phase 2 of the study. The investigators will also be assessing the acceptability of recruitment strategy and data collection to participants.
The effect of pre-pregnancy factors (biophysical, genetic, socioeconomic, behavioural and psychological) on obstetric, cardiovascular, socioeconomic, behavioural and psychological outcomes will all be examined.
详细描述
The aim of this study is to recruit 300 women. The investigators anticipate that a subset of recruits will become pregnant during the pilot study.
This is a feasibility study with two phases:
- Phase 1: A detailed characterisation of nulliparous women who have an address in Oxfordshire or work in Oxfordshire
- Phase 2: Detailed assessment of events during and immediately after a first viable pregnancy.
During the Phase 1 visit:
- Participation is explained by a research nurse/midwife, any questions are answered and women, who agree, sign the consent form.
- A questionnaire covering medical and family history, socioeconomic information, behavioural factors and psychological measures will be completed.
- Baseline anthropometry - height, weight, hip/ waist ratio, USS measurement of fat (thigh and abdomen), bioimpedence.
- Cardiovascular - pulse and BP (peripheral / central), arterial stiffness, echocardiogram, carotid imaging and endothelial function (endo-check) tests are completed.
- Fasting venous blood sample (maximum 40 mls) including whole blood for maternal DNA.
- Urine sample
- Salivette
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
- •Participant is willing and able to give informed consent for participation in the study
- •Participant is female, aged 18-40 years
- •Participant is not pregnant
- •Participant lives or works in Oxfordshire
排除标准
- •A previous live birth or still birth after 24 weeks gestation
结局指标
主要结局
Recruitment feasibility
时间窗: 2 years
This will be measured by the number of participants recruited into Phase 1 (pre-pregnancy) and Phase 2 (pregnancy) of the study. The investigators intend to recruit 300 participants into Phase 1 and 100 participants into Phase 2.
次要结局
- Live birth rate(2 years)
- Acceptability of the data collection procedures to participants.(2 years)
- Incidence of miscarriage and ectopic pregnancy in Phase 2 participants(2 years)
- Incidence of pregnancy within 12 months of recruitment.(2 years in total, 12 month for each recruit)
- Acceptability of the recruitment strategy to participants(2 years)
- The retention of participants in Phase 2(2 years)
- Incidence of loss to follow-up(2 years)
- Proportion of participants who provide full data at baseline and throughout pregnancy(2 years)
研究者
Ingrid Granne
Senior Research Fellow in Reproductive Medicine
Oxford University Hospitals NHS Trust