Substance-Related DisordersNCT02797990
Conflict Between Maternal Autonomy and Child Health in Substance-use
An observational study of Substance-Related Disorders and Alcohol-Related Disorders, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
Trial summary
Qualitative project, comprising open-ended semi-structured interviews with healthcare workers, who provide antenatal care to substance-using women. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders, Alcohol-Related Disorders, Amphetamine-Related Disorders
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Trevor Mann Baby Unit, Royal Sussex County Hospital
Brighton, BN2 5BE
About this study
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
Qualitative project, comprising open-ended semi-structured interviews with healthcare workers, who provide antenatal care to substance-using women.
Read the 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.
- Conditions
- Substance-Related Disorders, Alcohol-Related Disorders, Amphetamine-Related Disorders, Inhalant Abuse, Cocaine-Related Disorders, Opioid-Related Disorders
- 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]
- Medical subject headings
- Substance-Related Disorders, Alcohol-Related Disorders, Amphetamine-Related Disorders, Inhalant Abuse, Cocaine-Related Disorders, Opioid-Related Disorders, Marijuana Abuse, Substance Abuse, Intravenous
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptions of conflict between maternal and child-centred approaches
Qualitative data of perceptions of conflict.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloe Knox, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797990
- Sponsor's protocol ID
- 10890
- Other IDs
- 201264, FI0816115
- Status last verified
- May 2016
- First submitted
- 9 Jun 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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. doi: 10.1080/01443610500508121.
PubMed 16698620
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02797990
- Acronym / sponsor ID
- 10890
- Conditions
- Substance-Related Disorders, Alcohol-Related Disorders, Amphetamine-Related Disorders, Inhalant Abuse, Cocaine-Related Disorders, Opioid-Related Disorders
- 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]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceptions of conflict between maternal and child-centred approaches
Time frame: 4 months
Qualitative data of perceptions of conflict.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Background: PubMed 16698620Sanaullah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chloe Knox principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance-Related Disorders and Alcohol-Related Disorders, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptions of conflict between maternal and child-centred approaches (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02797990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.