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Oxfordshire Women and Their Children's Health (OxWATCH)

10 de mayo de 2018 actualizado por: Ingrid Granne, Oxford University Hospitals NHS Trust

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.

Descripción general del estudio

Descripción detallada

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 estudio

De observación

Inscripción (Anticipado)

250

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 40 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

Participants will be 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. Participants must be willing to have research investigations before, during and after pregnancy.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recruitment feasibility
Periodo de tiempo: 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.
2 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Tasa de nacidos vivos
Periodo de tiempo: 2 años
2 años
The retention of participants in Phase 2
Periodo de tiempo: 2 years
The investigators aim to retain 90% of participants recruited into Phase 2 from 7 weeks gestation until delivery.
2 years
Incidence of pregnancy within 12 months of recruitment.
Periodo de tiempo: 2 years in total, 12 month for each recruit
2 years in total, 12 month for each recruit
Incidence of miscarriage and ectopic pregnancy in Phase 2 participants
Periodo de tiempo: 2 years
2 years
Incidence of loss to follow-up
Periodo de tiempo: 2 years
2 years
Proportion of participants who provide full data at baseline and throughout pregnancy
Periodo de tiempo: 2 years
2 years
Acceptability of the recruitment strategy to participants
Periodo de tiempo: 2 years
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.
2 years
Acceptability of the data collection procedures to participants.
Periodo de tiempo: 2 years
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.
2 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Investigador principal: Ingrid Granne, University of Oxford

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2013

Finalización primaria (Anticipado)

31 de diciembre de 2018

Finalización del estudio (Anticipado)

31 de diciembre de 2018

Fechas de registro del estudio

Enviado por primera vez

20 de enero de 2015

Primero enviado que cumplió con los criterios de control de calidad

14 de abril de 2015

Publicado por primera vez (Estimar)

17 de abril de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de mayo de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

10 de mayo de 2018

Última verificación

1 de mayo de 2018

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

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