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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Oxford, Reino Unido, OX39DU
- Recrutamento
- The Nuffield Department of Obstetrics and Gynaecology
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Contato:
- Ingrid Granne
- Número de telefone: 01865 740887
- E-mail: ingrid.granne@obs-gyn.ox.ac.uk
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Contato:
- Sian Harrison
- Número de telefone: 01865 289358
- E-mail: sian.harrison@phc.ox.ac.uk
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Recruitment feasibility
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Taxa de nascidos vivos
Prazo: 2 anos
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2 anos
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The retention of participants in Phase 2
Prazo: 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.
Prazo: 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
Prazo: 2 years
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2 years
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Incidence of loss to follow-up
Prazo: 2 years
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2 years
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Proportion of participants who provide full data at baseline and throughout pregnancy
Prazo: 2 years
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2 years
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Acceptability of the recruitment strategy to participants
Prazo: 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.
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ingrid Granne, University of Oxford
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 12/SC/0492
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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