Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2013-04-30
2018-12-31
Brief Summary
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The effect of pre-pregnancy factors (biophysical, genetic, socioeconomic, behavioural and psychological) on obstetric, cardiovascular, socioeconomic, behavioural and psychological outcomes will all be examined.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Participant is female, aged 18-40 years
* Participant is not pregnant
* Participant lives or works in Oxfordshire
Exclusion Criteria
18 Years
40 Years
FEMALE
Yes
Sponsors
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University of Oxford
OTHER
Oxford University Hospitals NHS Trust
OTHER
Responsible Party
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Ingrid Granne
Senior Research Fellow in Reproductive Medicine
Principal Investigators
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Ingrid Granne
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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The Nuffield Department of Obstetrics and Gynaecology
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Harrison S, Petkovic G, Chevassut A, Brook L, Higgins N, Kenworthy Y, Selwood M, Snelgar T, Arnold L, Boardman H, Heneghan C, Leeson P, Redman C, Granne I. Oxfordshire Women and Their Children's Health (OxWATCH): protocol for a prospective cohort feasibility study. BMJ Open. 2015 Nov 9;5(11):e009282. doi: 10.1136/bmjopen-2015-009282.
Other Identifiers
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12/SC/0492
Identifier Type: -
Identifier Source: org_study_id
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