RecruitingNCT05766007

Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum

Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum: An Observational Cohort Study


Sponsor

University of Liverpool

Enrollment

125 participants

Start Date

Aug 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to learn about how long-acting injectable antipsychotic (LAIA) medications are affected by the changes that take place in the body during pregnancy, and how much an unborn baby is exposed to. The investigators are also interested in the amount of these drugs that enters into breastmilk and taken by babies during breastfeeding. In addition to their regular clinic visits to receive long-acting mental health medicine injection, participants will be invited for up to four study visits between day 2 and 14 after the injection. This will happen only once during pregnancy, and once during the breastfeeding period to collect a few drops of blood on special filter paper card from the finger using safety lancet. A few drops of breastmilk will also be collected. Immediately after delivery, a few drops of blood will be collected from the mother, umbilical cord and the baby heel. The investigators will use these samples to determine the amount of the drug in the body during pregnancy and compare this to the amount during the breastfeeding period. Additionally, every month during the third trimester, and during the first 3 months postpartum, participants will complete a questionnaire (using the Liverpool University Neuroleptic Side Effect Scale) to document how they are feeling. Clinical improvement will be documented by the primary care provider using the Clinical Global Impressions Scale. Findings from this study are expected to help healthcare providers to understand these drugs better so that they can make informed decisions about if and how to use these drugs in women who become pregnant or are breastfeeding.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This study is following pregnant women and new mothers who have schizophrenia or other psychotic conditions and are being treated with long-acting injectable antipsychotic medications, to understand how these treatments affect both mother and baby. **You may be eligible if...** - You are currently pregnant or breastfeeding - You have a diagnosis of schizophrenia, mania, or another psychotic condition - You are already receiving a long-acting injectable antipsychotic (such as risperidone or paliperidone) as ongoing treatment - You are at least 18 years old - If pregnant, you plan to deliver at the study facility **You may NOT be eligible if...** - You are unable to understand or participate in the study procedures - You do not meet the above criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(6)

Federal Medical Centre

Makurdi, Benue State, Nigeria

Federal Neuropsychiatric Hospital

Kaduna, Kaduna State, Nigeria

Federal Neuropsychiatric Hospital

Yaba, Lagos, Nigeria

Neuropsychiatric Hospital

Abeokuta, Ogun State, Nigeria

Neuropsychiatric Specialist Hospital

Akure, Ondo State, Nigeria

Obafemi Awolowo University Teaching Hospital

Ile-Ife, Osun State, Nigeria

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NCT05766007


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