NCT04653948

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,423

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

3.9 years

First QC Date

November 10, 2020

Last Update Submit

November 22, 2023

Conditions

Group B Streptococcus Carrier in ChildbirthGroup B Streptococcal Infection, Late-OnsetGroup B Streptococcal Infection, Early-OnsetGroup B Streptococcus Neonatal SepsisGroup B Strep Infection

Outcome Measures

Primary Outcomes (12)

  • Maternal, neonatal and infant mortality - Electronic Medical Records.

    To describe the maternal and neonatal mortality (%) using hospital electronic medical records (EMR).

    24 months

  • Maternal deaths in a prospective cohort.

    To describe proportion (%) of maternal deaths in a prospective cohort of 4000 mother infant dyads using standardised Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) definitions.

    24 months

  • Maternal gestational diabetes mellitus

    To describe proportion (%) of women diagnosed with gestational diabetes mellitus in a prospective cohort of 4000 mother infant dyads using standardised Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) definitions.

    24 months

  • Spontaneous abortions & ectopic pregnancy

    To describe proportion (%) of women that experience spontaneous abortions and ectopic pregnancies in a prospective cohort of 4000 mother infant dyads using standardised Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) definitions.

    24 months

  • Hypertensive disorders

    To describe proportion (%) of women that experience hypertensive disorders of pregnancy in a prospective cohort of 4000 mother infant dyads using standardised Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) definitions.

    24 months

  • Chorioamnionitis & endometritis

    To describe proportion (%) of women that experience chorioamnionitis, endometritis or infection following incomplete abortion in a prospective cohort of 4000 mother infant dyads using standardised Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) definitions.

    24 months

  • Haemorrhage

    To describe proportion (%) of women that experience antepartum or postpartum haemorrhage in a prospective cohort of 4000 mother infant dyads using standardised Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) definitions.

    24 months

  • Fetal distress and dysfunctional labor

    To describe proportion (%) of women that experience fetal distress or dysfunctional labor in a prospective cohort of 4000 mother infant dyads using standardised Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) definitions.

    24 months

  • Fetal growth restriction

    To describe proportion (%) of pregnancies diagnosed with fetal growth restriction in a prospective cohort of 4000 mother infant dyads using standardised Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) definitions.

    24 months

  • Birth outcomes (low-birthweight, stillbirths, prematurity)

    To describe proportion (%) of births that are low-birthweight, premature or stillborn in a prospective cohort of 4000 mother infant dyads using standardised Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) definitions.

    24 months

  • Neonatal outcomes

    To describe proportion (%) of liveborn babies that are diagnosed with neonatal encephalopathy, neonatal infections, respiratory distress, seizures or die in the neonatal period in a prospective cohort of 4000 mother infant dyads using standardised Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) definitions.

    24 months

  • Infant Outcomes

    To describe proportion (%) of liveborn babies that die in infancy in a prospective cohort of 4000 mother infant dyads using standardised Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) definitions.

    24 months

Secondary Outcomes (1)

  • Maternal, obstetric, neonatal and infant outcomes - Electronic Medical Records

    24 months

Study Arms (2)

Cohort Study

Women greater than or equal (≥) to 18 years of age and emancipated minors aged between 14 and 17 years of age seeking antenatal care at Kawempe National Referral Hospital in their first and second trimesters of pregnancy will be invited to participate in the study until a sample size of at least 4000 women is achieved. They will be followed-up along with their liveborn infants until a minimum of 14 weeks post-delivery.

EMR Cohort

Anonymised data from the entire maternal and infant population that attend Kawempe Hospital for antenatal and/or delivery +/- post-partum care during the two-year study period will be analysed to describe maternal, obstetric and neonatal outcomes.

Eligibility Criteria

Age14 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipants must be pregnant.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will enrol pregnant women from the general population who present for antenatal care at Kawempe Hospital and follow them and their liveborn infants for a minimum of 14 weeks postpartum up until a maximum of 9 months.

You may qualify if:

  • Willing and able to give written informed consent
  • ≥ 14 years of age
  • Pregnant in the first or second trimester
  • Planning to attend routine antenatal care visits and delivery at Kawempe Hospital
  • Planning to stay within Kampala or nearby Wakiso district until at least 9 months post-delivery
  • Willing to attend immunization visits at 10, 6 weeks and 14 weeks to 9 months' end of follow-up visit at Kawempe Hospital
  • Willing to be contacted by phone and/or be visited at home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUJHU Care Ltd

Kampala, Uganda

Location

Related Links

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Kirsty Le Doare, Dr

    St George's, University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2020

First Posted

December 4, 2020

Study Start

October 1, 2019

Primary Completion

August 28, 2023

Study Completion

September 30, 2024

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

UG(1)