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Maternal, Neonatal and Infant Outcomes at Kawempe National Referral Hospital

NCT04653948 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3423

Last updated 2023-11-24

No results posted yet for this study

Summary

Maternal immunisation is an evolving field that deserves special attention given its potential to have a significant positive impact on the health of women and children globally, and the potential safety and risk considerations associated with research in this population.

The goal of maternal immunisation is to boost maternal levels of specific antibodies to provide the newborn and young infant with sufficient immunity at birth, through trans placental transfer in-utero, to protect them through the period of increased vulnerability. Protection should be adequate to last until they are able to respond to their own active immunisations or infectious challenges. The success of the maternal neonatal tetanus immunisation program demonstrates the utility of this approach. Several other vaccines are recommended in pregnancy, including influenza and pneumococcal vaccines. Promising new vaccines for group B streptococcus (GBS) , respiratory syncytial virus (RSV) and cytomegalovirus are under development. They are targeted for use in pregnant women in high-, middle-, and low-income countries. However, these vaccines are likely to be of most benefit in LMICs that have high rates of vaccine preventable diseases.

The second work-package (WP2) of the PREPARE portfolio will describe the baseline maternal and neonatal outcomes using anonymised data collected using the routine Kawempe electronic medical records (EMR) system.

Furthermore, comprehensive data on pregnancy, neonatal and infant outcome will also be collected in a prospective cohort of women enrolled in the first and second trimesters while attending antenatal care at Kawempe Hospital with follow-up of the mother-infant pair(s) up until at least 14 weeks postpartum to establish longer term outcomes. Standardised case definitions will be used to classify the outcomes.

Conditions

  • Group B Streptococcus Carrier in Childbirth
  • Group B Streptococcal Infection, Late-Onset
  • Group B Streptococcal Infection, Early-Onset
  • Group B Streptococcus Neonatal Sepsis
  • Group B Strep Infection

Sponsors & Collaborators

  • MU-JHU CARE

    collaborator OTHER

  • MRC/UVRI and LSHTM Uganda Research Unit

    collaborator OTHER

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Kirsty Le Doare, Dr · St George's, University of London

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2023-08-28
Completion
2024-09-30

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04653948 on ClinicalTrials.gov