Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04825782 |
Other study ID # |
20-056 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 22, 2021 |
Est. completion date |
December 2024 |
Study information
Verified date |
March 2021 |
Source |
Liverpool School of Tropical Medicine |
Contact |
Stephanie Dellicour, PhD |
Phone |
+44 151 705 3287 |
Email |
Stephanie.dellicour[@]lstmed.ac.uk |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The MiMBa (Malaria in Mothers and Babies) Pregnancy Registry aims to generate robust evidence
on the safety of a range of antimalarials when used in pregnancy, particularly in the first
trimester. This will be a multi-country observational study and will be deployed in several
field sites in Africa.
Description:
Background:There is often no, or limited, safety data on drug use in early pregnancy and
particularly for drugs targeting tropical diseases because these are not widely used in
resource-rich countries with robust pharmacovigilance systems. It is critical to develop
surveillance systems to assess the safety of these drugs in pregnancy. Malaria in pregnancy
requires prompt and effective treatment to prevent adverse health consequences for the mother
and her unborn baby. Malaria infection in the first trimester has been associated with
miscarriage, preterm birth and low birth weight. Pregnant women in the first trimester are
often inadvertently treated with the same antimalarials as provided to the adult population
which is a concern for drugs which are contraindicated in early pregnancy, such as
artemisinin combination therapies (ACTs). This occurs either because they are not aware or do
not report that they are pregnant, or because quinine, the standard of care for malaria
treatment in the first trimester is not available. There is limited data available about the
safety of ACTs in early pregnancy. Investigators will develop a pregnancy registry for
monitoring the safety of antimalarial drugs during pregnancy with a focus on the first
trimester.
Overall Aim: The aim of the pregnancy registry is to generate robust data on the safety of a
range of antimalarials in pregnancy and particularly use in the first trimester to inform
regulators and policymakers.
Methods in Brief: Investigators will set-up a pregnancy exposure registry for antimalarial
drugs to capture safety data from women inadvertently exposed to (i.e. treated with)
antimalarials used in the general population that are not currently recommended for use in
the first trimester. To capture this safety data, several sentinel sites will be set-up in
multiple malaria-endemic countries to follow women from the moment the pregnancy is
identified and capture pregnancy outcomes (i.e. miscarriage, stillbirth, live birth). Some
sites (including Kenya) will provide pregnancy tests to enable early pregnancy detection and
referral to ANC to capture early miscarriages. Newborns will be assessed for congenital
anomalies at birth and up to 2 years of age. Any suspected case of congenital anomalies will
be referred for further assessment by a specialist (e.g. paediatrician) who will confirm the
diagnosis and advise on how to further manage any problems or complications. The national
referral system will be used in cases requiring further intervention. Exposure data will be
collected on any acute illnesses occurring during pregnancy, such as malaria and COVID-19,
and chronic conditions, such as HIV, TB, epilepsy or diabetes, and details of any treatment
given (including antimalarials). Antimalarial and other drug exposure data in early
pregnancy, i.e. before the pregnancy was known, will be captured through record linkage with
treatment records from outpatient departments, community health workers, and any other
treatment records. Women will provide informed consent for this data to be collected and to
be followed up throughout pregnancy. The pregnancy outcomes and prevalence of congenital
anomalies will then be compared between pregnancies exposed and those not exposed to specific
antimalarials during the first trimester.
Expected Outcomes: The expected outcome of this study is information and reassurance about
the safety profile of specific antimalarials, with a focus on the first trimester, to inform
malaria treatment guidelines. The findings will be shared with the relevant local and
national health and regulatory authorities and disseminated in scientific meetings and in
peer-reviewed journals. Data generated will be pooled with data from similar pregnancy
registries in other malaria-endemic countries and will be shared with the WHO/TDR Central
registry for epidemiological surveillance of drug safety in pregnancy and other relevant
pregnancy exposure registries.