End of follow-up in MA-CoV
The last mother and child follow-up visit in the MA-CoV study was in March 2023 in Mozambique. In total, the trial enrolled 1000 participants (500 in Mozambique and Gabon, respectively). After the end of follow-up, data entry and data base cleaning are being finalized.
Last participant recruited in MA-CoV in November 2022
The last participant of the MA-CoV study was recruited on 10th November 2022, in Libreville, Gabon. Within the MA-CoV project a total of 1000 pregnant women have been enrolled in Mozambique and Gabon.
While in Mozambique, the target of 500 enrolled participants was reached on 14th July 2022 in three different recruitment sites, recruitment in Gabon was extended in both recruiting hospitals in Libreville and Lambaréné in order to reach the target size.
Last delivery and end of follow-up are expected for mid-2023, after which data cleaning and analysis of the remaining samples will commence.
First participants enrolled in Mozambique in March 2022:
Screening and recruitment of participants in Mozambique started on the 9th of March 2022 in the health facility in Palmeira. On the 14th of March, recruitment started in two more hospitals in Manhiça. In total, enrolment of 500 participants in the MA-CoV cohort in Mozambique is anticipated.
First participant enrolled in MA-CoV in November 2021:
Screening of potential participants started on the 25th November in Gabon. The first participant of the MA-CoV study has been enrolled the same day in Lambaréné. Currently, 10 women have already been recruited.
At their first visits the participants´ health is being assessed, information on their pregnancy recorded and samples for SARS-CoV-2 serology collected. In case of a participant presenting with signs and symptoms suggestive of COVID-19, screening for SARS-CoV-2 via nasopharyngeal swab is performed and if tested positive, national guidelines for the management and treatment of the disease will be followed.
After the recruitment visit further monthly antenatal care visits are being scheduled until the delivery.
The protocol has been written and submitted for ethical approval. Protocol v01 dated 18th August received ethical clearance from CEIm at the Barcelona Hospital Clinic on 23/09/2021. The protocol is currently under review of the CNRS in Gabon and the CNBS in Mozambique, a positive response is expected during October.
Study tools and database are under development.
The project started on 1st July 2021 and the Kick-off meeting (online) took place on 27th July 2021.