Bacterial Vaginoses Clinical Trial
Official title:
Effects of Metronidazole Plus Intermittent Preventive Treatment of Malaria in Pregnancy on Birth Outcomes: a Randomised Controlled Trial in Zambia
Verified date | March 2023 |
Source | London School of Hygiene and Tropical Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Malaria in pregnancy has devastating consequences for mother and foetus. WHO recommends intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) for asymptomatic women, but high-level parasite resistance to SP threatens its efficacy. Dihydroartemisinin-piperaquine (DP) has the potential to replace SP for IPTp. However, the DP strategy has not been found to be superior to SP for reducing the incidence of low birthweight (LBW), small-for-gestational age (SGA), or preterm birth. This may be the result of sulphadoxine having antibacterial properties; it is derived from sulphonamide, which have been used for decades to treat curable STIs/RTIs. However, SP is unlikely to be curative of STIs/RTIs, nor highly effective against malaria parasites. Thus, combination treatment that contains a more efficacious antimalarial and a more efficacious anti-STI/RTI may produce better birth outcomes. The investigators will therefore determine whether combining SP with metronidazole (MTZ) or, separately, DP with MTZ can improve birth outcomes more than SP alone, potentially paving the way for integrated control strategies that will reduce the dual burden of malaria and curable STIs/RTIs. This is an individually-randomized, 3-arm, partially-placebo controlled superiority trial comparing the efficacy, safety and tolerance of IPTp-SP versus IPTp-SP with MTZ, or IPTp-DP with MTZ to reduce adverse birth outcomes attributable to malaria and curable STIs/RTIs in 5,436 women in the Nchelenge District of Zambia.
Status | Completed |
Enrollment | 5436 |
Est. completion date | March 31, 2023 |
Est. primary completion date | October 21, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Pregnant women - HIV-negative - Gestational age from Week 16 and 0 Days to Week 28 and 0 Days (measured by sonography) - Carrying a single viable pregnancy - Resident in the study area - Express willingness to adhere to scheduled and unscheduled study visit procedures, and deliver at a trial facility Exclusion Criteria: - HIV-positive - Carrying multiple pregnancies (twins, etc.), - Known cardiac ailment - Severe malformations or nonviable pregnancy observed by ultrasound - History of receiving IPTp-SP during the current pregnancy - Known allergy or contraindication to any of the study drugs - Unable to give consent - Concurrently participating in any other trial, including prior enrolment in this trial. |
Country | Name | City | State |
---|---|---|---|
Zambia | Nchelenge District Health Facilites | Nchelenge | Luapula Province |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine |
Zambia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse pregnancy outcome | Composite endpoint of foetal morbidity, defined as any of the following: foetal loss (spontaneous abortion or stillbirth), singleton live births born with low birthweight (LBW), or preterm (PT) (LBW-PT), and subsequent neonatal death by day 28. | 8 months | |
Secondary | Individual components of the primary outcome- adverse pregnancy outcomes | Prevalence of individual components of primary outcome | 8 months | |
Secondary | Foetal loss | Spontaneous abortion or stillbirth (binary) | 8 months | |
Secondary | Neonatal mortality | Death in the first 28 days of life (binary) | 8 months | |
Secondary | Low birthweight | Birthweight <2.5 kg (binary) | 8 months from randomisation | |
Secondary | Preterm birth | Birth at <37 gestational weeks | 8 months from randomisation | |
Secondary | Birth weight (continuous) | Weight at birth (g) | 8 months from randomisation | |
Secondary | Gestational age at delivery (continuous) | Based on gestational age measured by ultrasound at enrolment (days) | 8 months from randomisation | |
Secondary | Z-score for birthweight (continuous) | Z-score for birthweight (g) from regional population reference | 8 months from randomisation | |
Secondary | Small for gestational age (binary) | Estimated as a stand-alone secondary outcome using the 10th percentile of regional reference charts on the corrected birthweight | 8 months from randomisation | |
Secondary | Clinical malaria during pregnancy (binary) | Clinical malaria at any point from enrolment including delivery and 28 day postpartum, both:
Documented fever (=37.5°C), or recent history of fever in the past 24 hours, or other symptoms of acute illness that resulted in a woman seeking care with an unscheduled visit Maternal malaria patent infection detectable by Rapid Diagnostic Test (RDT) for women with malaria symptoms only |
8 months from randomisation | |
Secondary | Maternal malaria infection (binary) | Malaria infection detected by PCR during pregnancy in the peripheral blood at any point during pregnancy (scheduled and unscheduled visits) from study registration, including delivery. | 8 months from randomisation | |
Secondary | Any malaria at delivery (binary) | Malaria infection at delivery detected in peripheral blood by PCR or placental blood by microscopy, PCR or histology (active infection) | 8 months from randomisation | |
Secondary | Placental malaria infection (binary) | Placental malaria detected by microscopy, PCR , or histology (active and past infection) including any Plasmodium species detected in the placental blood or biopsy tissue by either:
Placental incision smear microscopy (standard microscopy) PCR placental blood (maternal) Placental malaria by histology (active and past infection) |
8 months from randomisation | |
Secondary | Congenital malaria infection (binary) | Malaria infection detected in foetal cord blood of the new born at birth by standard microscopy | 8 months from randomisation | |
Secondary | Placental malaria by histology (binary) | Active Infection:
Chronic: pigment present and asexual parasites present Acute: pigment absent and asexual parasites present Past Infection: Pigment in fibrin detected in the absence of asexual parasites. Placental histology categories Any Active Active acute Active chronic Past |
8 months from randomisation | |
Secondary | Placental Inflammation or chorioamnionitis (binary) | Any inflammation in the placenta or chorioamnionitis detected by placental histology | 8 months from randomisation | |
Secondary | Maternal anaemia (binary) and haemoglobin concentration (continuous (g/dL) at enrolment and delivery | Definition:
No anaemia (Hb >11 g/dL) Mild (Hb >10 to <11 g/dL) Moderate (Hb >7 to <10 g/dL Severe (Hb <7 g/dL) |
8 months from randomisation | |
Secondary | Congenital anaemia in umbilical cord blood at delivery | Hb<12.5 g/dL in umbilical cord blood at birth, which is 2 standard deviations below the mean cord Hb in developed countries | 8 months from randomisation | |
Secondary | Congenital malformations (binary) | Physical abnormality of live born baby detected at delivery or newly noted abnormality during the infant visits (7 days or 2-6 weeks post-natal) | 8 months from randomisation | |
Secondary | Maternal mortality (binary) | Maternal mortality from registration until 28 days after delivery | 8 months from randomisation | |
Secondary | SAEs and AEs defined by MedDRA (listings) | AEs and SAEs will be defined according to the Medical Dictionary for Regulatory Activities (MedDRA) and reported by study arm:
Overall By system organ class and preferred term |
8 months from randomisation | |
Secondary | History of vomiting study drug - Prevalence at each cycle of treatment (binary) | Vomited within 30 minutes of taking study drug at any scheduled administration | 8 months from randomisation | |
Secondary | Dizziness - Prevalence at each cycle of treatment | Dizziness at any point within 30 minutes of first drug administered during a treatment cycle, reported as Mothers adverse event | 8 months from randomisation | |
Secondary | Gastrointestinal complaints - Prevalence at each cycle of treatment (binary) | Nausea or vomiting within 30 minutes of first drug administered during a treatment cycle | 8 months from randomisation | |
Secondary | Presence of any one or more STIs/RTIs - Prevalence at enrolment (binary) | Any or more infection of syphilis, gonorrhoea, chlamydia, trichomoniasis, and bacterial vaginosis | 8 months from randomisation |
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