Trichomoniasis and bacterial vaginosis Fertility-female
Conditions
Interventions
TV and BV POC test
TV NAAT and BV Nugent Scoring
Sponsors
Tropical Disease Research Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women confirmed by ultrasound 2. Gestational age from Week 13 and 0 Days 3. Willing and able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. History of using metronidazole or clindamycin during current pregnancy 2. Known allergy or contraindication to metronidazole 3. Unable to give written informed consent 4. Previously having participated in this study 5. Have (a) used a vaginal cream or ointment product, (b) douched, or (c) used spermicides, vaginal lubricants or feminine sprays within 72 hours of testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Performance of the TV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to NAAT among asymptomatic and symptomatic pregnant women combined. 2. Performance of the BV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to Nugent scoring among asymptomatic and symptomatic pregnant women combined. We define symptomatic as having one or more of the following: Unusual vaginal discharge, pain during urination, itching or burning of the vulva, sores, blisters, ulcers, warts or rashes in the genital area, lumps and bumps on the genitals, lower abdominal pain 3. The minimal operational characteristics of these POC tests and their acceptability to patients and healthcare providers | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Performance of the TV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to NAAT among asymptomatic only pregnant women. 2. Performance the TV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to NAAT among symptomatic only pregnant women. 3. Performance of the BV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to Nugent scoring among asymptomatic only pregnant women. 4. Performance of the BV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to Nugent scoring among symptomatic only pregnant women. 5. Performance of the TV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to NAAT among pregnant women grouped by gravidae and parity. 6. Performance of the BV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to Nugent scoring among pregnant women grouped by gravidae and parity. 7. Performance of the TV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to NAAT among pregnant women of different age groups: 35 and 35. 8. Performance of the BV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to Nugent scoring among pregnant women of different age groups: 35 and 35. 9. Performance of the TV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to NAAT among pregnant women of different gestational age groups: 20 10. Performance of the BV POC test [sensitivity, specificity, positive predictive value and negative predictive values] compared to Nugent scoring among pregnant women of different gestational age | — |
Countries
Zambia
Contacts
Public ContactEnesia Chaponda
Senior lecturer and a researcher
Outcome results
None listed