Oxfordshire Women and Their Children's Health (OxWATCH)
Oxfordshire Women and Their Children's Health- A Feasibility Study
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.
研究概览
详细说明
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
Once a participant has become pregnant she is eligible to enter phase 2 of the study. Phase 2 involves 6 further visits at 7, 11-13, 18-20, 28, 34 weeks gestation and 3 months post-delivery. During these visits repeated measurements of the above investigations will be carried out.
In addition, there will be a fetal ultrasound at 7 and 28 weeks and questionnaires at 7, 28 and 3 months post-delivery. An acceptability questionnaire will also be given to participants following completion of the study.
The end of the feasibility study will be the date of the final phase 2 visit of the last participant becoming pregnant during the feasibility study.
By collecting the above data the investigators anticipate recording and reporting longitudinal data in relation to the following:
•Incidence of obstetric complications
The incidence of pre-eclampsia, gestational diabetes, pregnancy induced hypertension, antenatal and postnatal depression and preterm birth.
•Longitudinal variation in cardiovascular parameters
Changes in longitudinal measures of blood pressure, carotid intima media thickness, pulse wave velocity, cardiac structure and function and endothelial function from pre-conception until 34 weeks gestation.
•Longitudinal changes in socioeconomic factors
By use of a questionnaire at pre-conception, 7 weeks gestation and 28 weeks gestation we will record employment and relationship status.
•Longitudinal changes in behavioural factors
By use of a questionnaire at pre-conception, 7 weeks gestation and 28 weeks gestation the investigators will record diet, weight control and perception, exercise, smoking, alcohol use and drug use.
•Longitudinal changes in psychological factors
By use of a questionnaire at pre-conception, 7 weeks gestation and 28 weeks gestation the investigators will record levels of anxiety, depression and quality of life and perceived health status.
•Longitudinal changes in the health status of participant and their family
By use of a questionnaire at pre-conception the investigators will record the participants' medical and family history, reproductive and sexual history and pain perception. At 7 weeks gestation and 28 weeks gestation the questionnaire will enquire about any changes or additions to the participants' medical and family history as well as reproductive and sexual health and pain perception.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Oxford、英国、OX39DU
- 招聘中
- The Nuffield Department of Obstetrics and Gynaecology
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接触:
- Ingrid Granne
- 电话号码:01865 740887
- 邮箱:ingrid.granne@obs-gyn.ox.ac.uk
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接触:
- Sian Harrison
- 电话号码:01865 289358
- 邮箱:sian.harrison@phc.ox.ac.uk
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- A previous live birth or still birth after 24 weeks gestation
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Feasibility Study
Nulliparous women of reproductive age (18-40 years), who are not pregnant but could have a planned or unplanned pregnancy during the duration of the study.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recruitment feasibility
大体时间:2 years
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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.
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2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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活产率
大体时间:2年
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2年
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The retention of participants in Phase 2
大体时间:2 years
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The investigators aim to retain 90% of participants recruited into Phase 2 from 7 weeks gestation until delivery.
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2 years
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Incidence of pregnancy within 12 months of recruitment.
大体时间:2 years in total, 12 month for each recruit
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2 years in total, 12 month for each recruit
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Incidence of miscarriage and ectopic pregnancy in Phase 2 participants
大体时间:2 years
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2 years
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Incidence of loss to follow-up
大体时间:2 years
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2 years
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Proportion of participants who provide full data at baseline and throughout pregnancy
大体时间:2 years
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2 years
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Acceptability of the recruitment strategy to participants
大体时间:2 years
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At the end of a participant's involvement in the study the participant will be asked to complete an anonymous, validated acceptability questionnaire.
It is anticipated that this will provide insight into why participants took part, the acceptability of the recruitment strategy, the participant's reactions to research participation and how acceptable the participant found study requirements and assessments.
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2 years
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Acceptability of the data collection procedures to participants.
大体时间:2 years
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At the end of a participant's involvement in the study the participant will be asked to complete an anonymous, validated acceptability questionnaire.
It is anticipated that this will provide insight into why participants took part, the acceptability of the recruitment strategy, the participant's reactions to research participation and how acceptable the participant found study requirements and assessments.
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2 years
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合作者和调查者
调查人员
- 首席研究员:Ingrid Granne、University of Oxford
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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