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Screening for Group B Streptococcus bacteria in Malawian women going through childbirth to guide decisions on protective antibiotic prescription

A feasibility study of intrapartum Group B Streptococcus testing using the loop-mediated isothermal amplification assay to guide antibiotic prophylaxis in Malawi

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN16832895
Enrollment
3200
Registered
2022-06-09
Start date
2021-01-01
Completion date
Unknown
Last updated
2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Screening for Group B Streptococcus colonisation in pregnant women Infections and Infestations

Interventions

The study population includes women who present to the labor ward of Queen Elizabeth Central Hospital, Blantyre Malawi. Trained Research Midwife Nurses approach the women to provide information about

Sponsors

Queen's University Belfast
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Pregnant women in active labour at a gestational age greater than 34 weeks (=4 cm dilated and regular contractions) The researchers will also aim to identify and recruit women who present to the labour ward with premature rupture of membranes (PROM), but who are not yet in labour (<4 cm dilated). If recruited into the study, they will only be tested for GBS when labour begins (=4 cm dilated and regular contractions).

Exclusion criteria

Exclusion criteria: 1. Preterm labour with estimated gestation <34 weeks as the obstetric management highly variable in this group, including the administration of tocolytic drugs 2. Labour with an estimated fetal size of <2 kg (as a proxy for gestational age, which may not be reliable) 3. Presentation in labour with cervical dilation =8cm as there is little likelihood of achieving testing and IAP before they deliver

Design outcomes

Primary

MeasureTime frame
Colonisation with Group B Streptococcus measured using the loop-mediated isothermal amplification assay (LAMP) during labour at hospital admission

Secondary

MeasureTime frame
1. Results turnaround time from sample collection (vaginal and rectal swabs) to the administration of ampicillin in those positive for Group B Streptococcus 2. Concentration of ampicillin in cord blood at delivery measured using high-performance liquid chromatography (HPLC) in GBS-positive women given ampicillin

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026