Depression Clinical Trial
Official title:
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.
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.
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