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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02419898
Other study ID # 12/SC/0492
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2013
Est. completion date December 31, 2018

Study information

Verified date May 2018
Source Oxford University Hospitals NHS Trust
Contact Ingrid Granne
Phone 01865 740887
Email ingrid.granne@obs-gyn.ox.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

The effect of pre-pregnancy factors (biophysical, genetic, socioeconomic, behavioural and psychological) on obstetric, cardiovascular, socioeconomic, behavioural and psychological outcomes will all be examined.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Locations

Country Name City State
United Kingdom The Nuffield Department of Obstetrics and Gynaecology Oxford

Sponsors (2)

Lead Sponsor Collaborator
Oxford University Hospitals NHS Trust University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 years
Secondary 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. 2 years
Secondary Incidence of pregnancy within 12 months of recruitment. 2 years in total, 12 month for each recruit
Secondary Live birth rate 2 years
Secondary Incidence of miscarriage and ectopic pregnancy in Phase 2 participants 2 years
Secondary Incidence of loss to follow-up 2 years
Secondary Proportion of participants who provide full data at baseline and throughout pregnancy 2 years
Secondary 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. 2 years
Secondary 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. 2 years
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