PregnancyOxWATCHNCT02419898
Oxfordshire Women and Their Children's Health
An observational study of Pregnancy and Pre-eclampsia, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Pre-eclampsia, Gestational Diabetes
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- A previous live birth or still birth after 24 weeks gestation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Nuffield Department of Obstetrics and Gynaecology
Oxford, OX39DU
Ingrid Granne, 01865 740887, ingrid.granne@obs-gyn.ox.ac.uk
Sian Harrison, 01865 289358, sian.harrison@phc.ox.ac.uk
About this study
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.
Read the 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.
- Conditions
- Pregnancy, Pre-eclampsia, Gestational Diabetes, Depression, Metabolic Disorders, Pregnancy Induced Hypertension
- Keywords
- Feasibility
- Medical subject headings
- Pre-Eclampsia, Diabetes, Gestational, Depression, Metabolic Diseases, Hypertension, Pregnancy-Induced, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
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.
Measured: 2 years
Secondary outcomes (8)
The retention of participants in Phase 2
The investigators aim to retain 90% of participants recruited into Phase 2 from 7 weeks gestation until delivery.
Measured: 2 years
Incidence of pregnancy within 12 months of recruitment.
Measured: 2 years in total, 12 month for each recruit
Live birth rate
Measured: 2 years
Incidence of miscarriage and ectopic pregnancy in Phase 2 participants
Measured: 2 years
Incidence of loss to follow-up
Measured: 2 years
Proportion of participants who provide full data at baseline and throughout pregnancy
Measured: 2 years
Acceptability of the recruitment strategy to participants
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.
Measured: 2 years
Acceptability of the data collection procedures to participants.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startApr 2013
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Principal investigator, Ingrid Granne, Oxford University Hospitals NHS Trust
- Investigators
- Ingrid Granne, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419898
- Sponsor's protocol ID
- 12/SC/0492
- Acronym
- OxWATCH
- Status last verified
- May 2018
- First submitted
- 20 Jan 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 26553837
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxfordshire Women and Their Children's Health- A Feasibility Study
- ClinicalTrials.gov ID
- NCT02419898
- Acronym / sponsor ID
- OxWATCH / 12/SC/0492
- Conditions
- Pregnancy, Pre-eclampsia, Gestational Diabetes, Depression, Metabolic Disorders, Pregnancy Induced Hypertension
- Keywords
- Feasibility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- Apr 2013
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- A previous live birth or still birth after 24 weeks gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recruitment feasibility
Time frame: 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.
8 secondary outcomes
The retention of participants in Phase 2
Time frame: 2 years
Incidence of pregnancy within 12 months of recruitment.
Time frame: 2 years in total, 12 month for each recruit
Live birth rate
Time frame: 2 years
Incidence of miscarriage and ectopic pregnancy in Phase 2 participants
Time frame: 2 years
Incidence of loss to follow-up
Time frame: 2 years
Proportion of participants who provide full data at baseline and throughout pregnancy
Time frame: 2 years
Acceptability of the recruitment strategy to participants
Time frame: 2 years
Acceptability of the data collection procedures to participants.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 26553837Harrison 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingrid Granne principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Pre-eclampsia, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingrid Granne (01865 740887, ingrid.granne@obs-gyn.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02419898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.