NCT02797990

Brief Summary

Qualitative project, comprising open-ended semi-structured interviews with healthcare workers, who provide antenatal care to substance-using women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 8, 2016

Status Verified

May 1, 2016

Enrollment Period

3 months

First QC Date

June 9, 2016

Last Update Submit

September 7, 2016

Conditions

Keywords

[G08.686.785.760.769.500][G08.686.785.760.769][N02.360][C25.775.650][C25.775.793][C25.775.635][C25.775.675][C25.775.300][C25.775.467][C25.775.225][C25.775.100][C25.775]

Outcome Measures

Primary Outcomes (1)

  • Perceptions of conflict between maternal and child-centred approaches

    Qualitative data of perceptions of conflict.

    4 months

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthcare workers may include Specialist Midwives, Obstetricians, Substance Misuse Charge Nurses, Neonatologists and Health Visitors. Women using substances are defined as those who are being seen at the clinic (either due to self-referral, or due to referral by a healthcare worker), at any time during their pregnancy. I have personal experience of working in this clinic, which is run in an NHS hospital on the South Coast of the UK.

You may qualify if:

  • Healthcare workers will be recruited based on their employment status; they must currently provide some form of antenatal are for women who engage in problematic use of substances (limited to illicit drugs, excluding tobacco and alcohol).
  • Healthcare workers will not be restricted by age, and all genders will be included. As the research is qualitative, a representative same is unnecessary.

You may not qualify if:

  • Healthcare workers will be excluded if they do not have experience of providing ante-natal care for women who engage in problematic substance misuse (limited to illicit drugs, excluding tobacco and alcohol) during their pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trevor Mann Baby Unit, Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Related Publications (1)

  • Sanaullah F, Gillian M, Lavin T. Screening of substance misuse during early pregnancy in Blyth: an anonymous unlinked study. J Obstet Gynaecol. 2006 Apr;26(3):187-90. doi: 10.1080/01443610500508121.

    PMID: 16698620BACKGROUND

MeSH Terms

Conditions

Substance-Related DisordersAlcohol-Related DisordersAmphetamine-Related DisordersInhalant AbuseCocaine-Related DisordersOpioid-Related DisordersMarijuana AbuseSubstance Abuse, IntravenousNeonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related DisordersInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Chloe Knox

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2016

First Posted

June 14, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

September 8, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations