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Intrapartum Azithromycin versus Postpartum Amoxicillin clavulanic acid Metronidazole combination in the prevention of puerperal sepsis amongst women who had vaginal delivery at Federal Teaching Hospital Katsina. A Randomised Controlled Trial.

Intrapartum Azithromycin versus Postpartum Amoxicillin clavulanic acid Metronidazole combination in the prevention of puerperal sepsis amongst women who had vaginal delivery at Federal Teaching Hospital Katsina. A Randomised Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202605587767119
Enrollment
660
Registered
2026-05-04
Start date
2026-05-04
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

puerperal sepsis

Interventions

intrapartum azithromycin
post partum amoxicillinclavulanic acid plus metronidazole

Sponsors

self sponsored
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: • Women aged 15-49years • Booked at FTH Katsina and at term (37–42 weeks gestation) • Planned for spontaneous vaginal delivery • No known allergies to azithromycin, amoxicillin-clavulanate, or metronidazole • Provide informed consent

Exclusion criteria

Exclusion criteria: • Women undergoing planned caesarean section or assisted vaginal delivery • Presence of clinical infection at admission • Use of systemic antibiotics within 7 days prior to delivery • HIV-positive women • Preterm labour (<37 weeks) • Anaemia with packed cell volume of less than 30%. • Antepartum haemorrhage • Women with prolonged premature rupture of membranes (occurring for more than 24 hours) before the onset of labour • Women with medical disorders that are routinely given prophylactic antibiotics during labour (Sickle Cell Anaemia, Diabetes Mellitus, Cardiac disease) • Women with intrauterine fetal death

Design outcomes

Primary

MeasureTime frame
the incidence of maternal genital infection within six weeks postpartum .

Secondary

MeasureTime frame
The secondary outcomes will include specific infections like endometritis, wound infection, pelvic abscess, mastitis, therapeutic use of antibiotics, readmission, admission to special care unit. Similarly for the neonate, neonatal sepsis, readmission, admission to Nicu, duration of hospital stays. Safety outcomes such as medication side effects such as nausea and vomiting, diarrhoea and allergy

Countries

Nigeria

Contacts

Public ContactAdeoye Tolulope kola

consultant obstetrician and gynaecologist

markelsin@gmail.com+2347031557256

Outcome results

None listed

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