The National Register of Antipsychotic Medication in Pregnancy (NRAMP)
NCT ID: NCT00686946
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
500 participants
OBSERVATIONAL
2005-01-31
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators hypothesize that the provision of such evidence-based guidelines will improve the management and outcomes for mother and baby during pregnancy, birth and the postnatal phase, providing a positive impact on maternal and child health and wellbeing for present and future generations.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Ethical duty of care aside, good antenatal treatment appears prudent given the greater risk of obstetric complications in women with schizophrenia (Sacker et al, 1996). In a meta analysis of studies examining outcomes for pregnant women with and without schizophrenia, evidence exists of a small but statistically significant increase in the risk of low birth weight and inferior neonatal condition in infants of the schizophrenia cohort (Sacker et al, 1996). A recent meta analysis (Webb, et al, 2005) summarized that exposure to maternal psychotic illness is associated with a "higher than expected" risk of perinatal and infant mortality, including an almost twofold chance of fetal death or stillbirth (p.1052). Jablensky and colleagues (2005) further discovered that women whose psychiatric illness commenced before the birth of their child were significantly more likely to experience obstetric complications than women whose first admission for mental illness was after the delivery. Moreover, the offspring of women with schizophrenia carry with them an increased risk for developing psychosis (Mednick, Parnas \& Schulsinger, 1987). This observation has driven the neurodevelopmental hypothesis about the aetiology of schizophrenia, which posits that alterations to early fetal brain development in utero might lead to a predisposition to the formation of schizophrenia later in life (Lewis \& Murray, 1987). Such perinatal contributions to adult mental health outcomes points to the necessity to provide pregnant women who have psychosis, with proper and specialized treatment.
Despite these clear arguments for a thorough understanding of the needs of pregnant women with schizophrenia, current research is limited. In particular, there is currently very little evidence regarding the use of antipsychotic medication in pregnancy upon fetal development and maternal health. Over the last four decades, intermittent studies have sought to investigate the teratogenicity of the older or typical antipsychotics upon fetal development. Earlier reports were generated from pregnancy outcomes of women treated with these medications for hyperemesis gravidarum, not from women with schizophrenia (Kerns, 1989); as such, it is difficult to extrapolate initial findings across these two cohorts with confidence. Limb defects in children born to women who were given large doses of haloperidol in early pregnancy are outlined in case reports (Goldberg \& Nissam, 1994). Patton and colleagues (2002) also reviewed three other larger studies and concluded that a significant increased chance exists for babies exposed to phenothiazines to develop congenital malformations, compared with the incidence within the general population.
The newer or second generation antipsychotics (SGAs) have not been studied in any great detail; to date, to our knowledge, there have been no blinded or randomized studies examining birth outcomes in women taking SGAs, and these are unlikely given ethical considerations. Prescribing guidelines laid out in MIMS (2003) for all current SGAs include pregnancy as a "special precaution" and despite the gravity of associated risks of teratogenesis, there are few publications examining atypical antipsychotic medication use in pregnant women. In their review, Patton and colleagues (2002) cite four studies on the outcome of clozapine use, noting that for a total five cases no congenital abnormalities were reported, although one infant experienced low grade fever and seizure, with gastroesophageal reflux. Grigoriadis and Seeman (2002) suggest that the increased risk of agranulocytosis and seizures in babies, coupled with the identification of both pregnancy and clozapine as potentially increasing the likelihood of thromboembolisms, render this a medication to be avoided during pregnancy. Twenty-three Olanzapine-exposed pregnancies were observed by Goldstein and colleagues (2000), who found there was no increased risk of spontaneous abortion, stillbirth, prematurity or major malformation. The authors were, however, swift to assert that studies of greater sample sizes and over a protracted time period are necessary before olanzapine can be declared "safe" with confidence.
Thus, clinicians remain in a conundrum; although in general today's antipsychotic drugs produce fewer side effects, are better tolerated by the patient, and more effectively target the symptoms of psychosis, little evidence has been presented to reassure prescribers that their impact upon fetal development is minimal. A proven, evidence based method for achieving a balance between maternal mental health with minimal risk to the fetus must be researched and evidenced. Therefore, we have established The National Register of Antipsychotic Medication in Pregnancy (NRAMP) as a non-interventional means of providing information about pregnancies and outcomes for women with psychosis, and their babies. Not only is NRAMP seeking to record large scale obstetric information in a prospective fashion, including pharmacotherapy during pregnancy and beyond, it is also capitalizing on the opportunity to track alterations to mental health symptoms of women during pregnancy and in the post partum period, and to gather valuable insights into the attitudes of this cohort as they make the transition into parenthood.
The combination of poor psychosocial history, existing involvement with child protection agencies, psychiatric diagnoses and admissions, medications and substance abuse, present many issues affecting outcomes for both mother and child during the perinatal period. Our study involves extensive collaboration between many different clinical groups, and will culminate in an important best-practice resource to improve the quality of life for both present and future generations. The identification of a history of serious mental illness and a planned management strategy are therefore essential if we are to improve outcomes for mother and baby.
This then, is the driving force behind the establishment of The National Register of Antipsychotic Medication in Pregnancy (NRAMP), and is a much-needed strategy to improve the management of serious mental illness for women who become pregnant.
This investigator initiated study has been funded by Janssen-Cilag, AstraZeneca, Hospira, Lilly and the Australian Rotary Health Research Fund. NB: AstraZeneca provided funding up to and including 250 consented participants. The study continues to recruit.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NRAMP
Participants take their antipsychotic medication as prescribed by their clinical treating teams.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Women who are pregnant or have had a baby in the last 12 months
* Women who are living in Australia
* Women who are able to provide informed consent
Exclusion Criteria
* Women who are not pregnant, or have not had a baby in the last 12 months
* Women who are unable to provide informed consent
18 Years
50 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen-Cilag Ltd.
INDUSTRY
AstraZeneca
INDUSTRY
Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
The Alfred
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jayashri Kulkarni, Professor
Chief Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Prof Jayashri Kulkarni, MBBS,FRANZCP
Role: PRINCIPAL_INVESTIGATOR
Monash Alfred Psychiatry Research Centre (MAPrc)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Monash Alfred Pyschiatry Research Centre, Alfred Hospital
Melbourne, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
114/04
Identifier Type: -
Identifier Source: org_study_id