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Single dose Azithromycin versus combined multi-dose Amoxicillin/Metronidazole prophylaxis following vaginal delivery for preventing postpartum infections: an open-label randomized controlled trial

Single dose Azithromycin versus combined multi-dose Amoxicillin/Metronidazole prophylaxis following vaginal delivery for preventing postpartum infections: an open-label randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202502658908116
Enrollment
200
Registered
2025-02-20
Start date
2024-04-07
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Pregnancy and Childbirth Postpartum infections

Interventions

Sponsors

Igodo Udien Sarah
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: All women who give consent and had hospital-supervised vaginal delivery at term without added risk for infection.

Exclusion criteria

Exclusion criteria: 1. Intrapartum fever =38°C or maternal sepsis 2. Penicillin or Macrolide allergy 3. History of anaphylaxis (a severe hypersensitivity reaction) to Penicillins or Macrolides, as documented in hospital notes. 4. Exposure to any antibiotic agent within 1 week before delivery 5. Prolonged rupture of membranes (=24 hrs) 6. Prolonged labour(>12hrs) 7. Suspected chorioamnionitis 8. Intrauterine fetal death 9. Women who do not give consent 10. Women who had home delivery

Design outcomes

Primary

MeasureTime frame
Clinical endometritis defined as when at least two of the following signs or symptoms are present: fever (=38°C), abdominal pain, uterine tenderness, or purulent drainage from the uterus, delay in uterine involution (less than 2cm per day during the first 8 days after delivery) with no other recognized cause and perineal wound infection.

Secondary

MeasureTime frame
Hospital readmission for presumed maternal infection within 42days of delivery, use of additional maternal antibiotic therapy.

Countries

Nigeria

Contacts

Public ContactWaripamo Petre Oweisi

Consultant Obgyn

Oweisipeter@gmail.com+2348037089554

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026