Oxfordshire Women and Their Children's Health

NCT02419898 | Unknown DMC

• 1 other identifier: 12/SC/0492
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Pre-eclampsia; Gestational Diabetes; Depression; Metabolic Disorders; Pregnancy Induced Hypertension; Cardiovascular Disorders

Keywords

Feasibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The retention of participants in Phase 2

  2 years

• Incidence of pregnancy within 12 months of recruitment.

  2 years in total, 12 month for each recruit

• Live birth rate

  2 years

• Incidence of miscarriage and ectopic pregnancy in Phase 2 participants

  2 years

• Incidence of loss to follow-up

  2 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• A previous live birth or still birth after 24 weeks gestation

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• University of Oxford: collaborator

Study Sites (1)

The Nuffield Department of Obstetrics and Gynaecology

Oxford, OX39DU, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 26553837 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

SST Serum, Citrate Platelet Free Plasma, EDTA Plasma, whole blood for DNA extraction, urine and saliva will be stored at -80°C for future studies.

MeSH Terms

Conditions

Pre-Eclampsia; Diabetes, Gestational; Depression; Metabolic Diseases; Hypertension, Pregnancy-Induced; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior; Hypertension; Vascular Diseases

Study Officials

• Ingrid Granne

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid Granne

CONTACT

01865 740887; ingrid.granne@obs-gyn.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow in Reproductive Medicine

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: April 17, 2015
• Study Start: April 1, 2013
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

GB (1)