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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02797990
Other study ID # 10890
Secondary ID 201264FI0816115
Status Completed
Phase N/A
First received June 9, 2016
Last updated September 7, 2016
Start date May 2016
Est. completion date September 2016

Study information

Verified date May 2016
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Institute for Health Research
Study type Observational

Clinical Trial Summary

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


Description:

Maternal substance use during pregnancy (including legal and illicit substances) is a fairly common global phenomenon, including in the UK. This can have significant effects on pregnancy, infant outcome and enduring consequences into adolescence. Babies born with neonatal abstinence syndrome may spend months in neonatal care units, requiring complex, 24hour care. Here, healthcare workers may experience conflict between preserving maternal autonomy, and the challenge of caring for a withdrawing newborn.

However, there is discrepancy between the objectives of policy-makers "Reducing the harm to children from parental problem drug use should become a main objective of policy and practice" and those recommended in healthcare "These women need supportive and coordinated care during pregnancy." Therefore, conflict arises between mother-centred and child-centred models of caring for pregnant women who use substances.

The objective of the proposed project is to investigate how healthcare workers providing treatment for pregnant women who use illicit substances perceive their duty of care and whether they experience tension between the conflicting objectives of mother-centred and child-centred approaches through semi-structured qualitative interviews. The investigators will explore the ways in which healthcare workers frame problematic substance misuse in pregnant women, what they perceive to be the major challenges in providing care and their views on the responsibility of a mother to have a healthy baby. The main hypothesis is that healthcare workers providing care for pregnant women engaging in problematic substance misuse experience conflict between mother-centred and child- centred approaches to care.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date September 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Locations

Country Name City State
United Kingdom Trevor Mann Baby Unit, Royal Sussex County Hospital Brighton

Sponsors (1)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Perceptions of conflict between maternal and child-centred approaches Qualitative data of perceptions of conflict. 4 months No
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