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Conflict Between Maternal Autonomy and Child Health in Substance-use

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ClinicalTrials.gov Identifier: NCT02797990
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date June 9, 2016
First Posted Date June 14, 2016
Last Update Posted Date September 8, 2016
Study Start Date May 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2016)
Perceptions of conflict between maternal and child-centred approaches [ Time Frame: 4 months ]
Qualitative data of perceptions of conflict.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02797990 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Conflict Between Maternal Autonomy and Child Health in Substance-use
Official Title Mother vs. Child? Healthcare Worker Perceptions of Conflict Between Maternal Autonomy and Child Health When Providing Care for Pregnant Women Engaging in Problematic Substance Use
Brief Summary Qualitative project, comprising open-ended semi-structured interviews with healthcare workers, who provide antenatal care to substance-using women.
Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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.
Condition
  • Substance-Related Disorders
  • Alcohol-Related Disorders
  • Amphetamine-Related Disorders
  • Inhalant Abuse
  • Cocaine-Related Disorders
  • Opioid-Related Disorders
  • Marijuana Abuse
  • Substance Abuse, Intravenous
  • Neonatal Abstinence Syndrome
  • Pregnancy
  • Pregnancy, High-Risk
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 7, 2016)
6
Original Estimated Enrollment
 (submitted: June 13, 2016)
5
Actual Study Completion Date September 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02797990
Other Study ID Numbers 10890
201264 ( Other Identifier: IRAS Number )
FI0816115 ( Other Identifier: LSHTM Sponsorship Certification Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party London School of Hygiene and Tropical Medicine
Study Sponsor London School of Hygiene and Tropical Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Chloe Knox London School of Hygiene and Tropical Medicine
PRS Account London School of Hygiene and Tropical Medicine
Verification Date May 2016