a clinical trial to study the efficacy of combination of two drugs,ampicillin plus azithromycin and ampicillin plus erythromycin in pregnant patients with preterm premature rupture of membranes

a prospective study to compare the efficacy of combination of ampicillin and azithromycin with ampicillin and erythromycin for prolonging latency in preterm premature rupture of membranes

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012449

Enrollment

114

Registered

2018-03-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- pregnant with preterm premature rupture of membranes

Interventions

Intervention1: Ampicillin plus Azithrymycin: Injection ampicillin 02 gm IV six hourly for 48 hrs, Azithromycin from third day 500 mg orally once daily for five days. Control Intervention1: Ampicillin

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women of 19 years to 40 years of age with preterm premature rupture of membranes and not in labour. Gestational age of 28 to 34 weeks. Single foetus gestation Randomization within 36 hours of rupture of membranes. Cervical dilatation less than or equal 04 cm.

Exclusion criteria

Exclusion criteria: Gestational age 34 weeks In preterm labour Cervical cerclage in situ Multifetal gestation Vaginal bleeding/Foul smelling vaginal discharge Maternal or foetal indication for delivery Placental abnormality H/o amniocentesis Had received corticosteroid or antibiotic within the last seven days Carrying a foetus with lethal anomalies H/o foetal surgery H/o abdominal trauma On antiretroviral therapy Known allergy or cntraindication to use of ampicillin, azithromycin and erythromycin.

Design outcomes

Primary

Measure	Time frame
LatencyTimepoint: Latency - from first antibiotic dose administration to the time of delivery	—

Secondary

Measure	Time frame
Safety of antibiotics Gestational age at delivery Chorioamnionitis Puerperal sepsis Birth weight APGAR score at birth RDS Neonatal sepsis Neonatal mortality Number of days of stay in NICU Timepoint: Puerperal sepsis-within 42 days of delivery Neonate-28 days of age	—

Countries

India

Contacts

Public ContactDR TULIKA JHA

COLLEGE OF MEDICINE AND SAGORE DUTTA HOSPITAL

papia.saha@yahoo.com91-9433207704

Outcome results

None listed

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