Oxfordshire Women and Their Children's Health

Depression Clinical Trial

— OxWATCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02419898
• Other study ID #: 12/SC/0492
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Disorders
• Depression
• Diabetes, Gestational
• Disease
• Eclampsia
• Gestational Diabetes
• Hypertension, Pregnancy-Induced
• Metabolic Diseases
• Metabolic Disorders
• Pre-eclampsia
• Pregnancy
• Pregnancy Induced Hypertension

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