OxWATCH: Oxfordshire Women and Their Children's Health

Sponsor

Oxford University Hospitals NHS Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT02419898

Collaborator

University of Oxford (Other)

250

Enrollment

Location

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Pre-eclampsia Gestational Diabetes Depression Metabolic Disorders Pregnancy Induced Hypertension Cardiovascular Disorders

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Oxfordshire Women and Their Children's Health- A Feasibility Study

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Dec 31, 2018

Anticipated Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Recruitment feasibility [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.

Secondary Outcome Measures

The retention of participants in Phase 2 [2 years]
The investigators aim to retain 90% of participants recruited into Phase 2 from 7 weeks gestation until delivery.
Incidence of pregnancy within 12 months of recruitment. [2 years in total, 12 month for each recruit]
Live birth rate [2 years]
Incidence of miscarriage and ectopic pregnancy in Phase 2 participants [2 years]
Incidence of loss to follow-up [2 years]
Proportion of participants who provide full data at baseline and throughout pregnancy [2 years]
Acceptability of the recruitment strategy to participants [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.
Acceptability of the data collection procedures to participants. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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