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Comparison of effectiveness of two different antibiotics courses in prevention of unfavourable health results of mother and baby in case of early rupture of membranes

Comparison of efficacy of two prophylactic antibiotic regimens for PPROM-A randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/065733
Enrollment
232
Registered
2024-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: O429- Premature rupture of membranes, unspecified as to length of time between rupture and onset of labor

Interventions

Intervention1: Cefuroxime and azithromycin: Patients giving informed written consent with singleton pregnancy with diagnosis of PPROM after 24 weeks and before 37 WEEKS will be randomized into 2 group

Sponsors

DrJyoti
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: – Patient giving written informed consent – Singleton pregnancy, PPROM after 24 weeks of gestation & before 37 weeks.

Exclusion criteria

Exclusion criteria: -Not giving consent – Conditions requiring expedite delivery or contraindication of conservative management like: Chorioamnionitis Fetal distress Placental abruption Active labour

Design outcomes

Primary

MeasureTime frame
Latency period Early neonatal sepsis rate-positive blood culture Chorioamnionitis rate Timepoint: Latency period-date of randomisation until date of delivery Early neonatal sepsis rate- within 3 days of delivery Chorioamnionitis rate-from day of randomisation until date of clinical/laboratory Chorioamnionitis diagnosis assessed up to 10 weeks

Secondary

MeasureTime frame
Neonatal weight Apgar score Neonatal intensive care unit (NICU) admission durationTimepoint: Neonatal weight [ Time Frame: at delivery] grams Apgar score [ Time Frame: 1 minute - 5minutes] score from 0 to 10 Other Neonatal intensive care unit (NICU) admission duration [Time Frame: days since delivery until rerelease from NICU, assessed up to 6 months]

Countries

India

Contacts

Public ContactDr Jyoti

KING GEORGES MEDICAL UNIVERSITY, LUCKNOW

gaganmlv@gmail.com9721250092

Outcome results

None listed

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