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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

Phase 4
Completed
Conditions
Health Condition 1: null- pregnant with preterm premature rupture of membranes
Registration Number
CTRI/2018/03/012449
Lead Sponsor
RGKAR MEDICAL COLLEGE KOLKATA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
114
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

Gestational age <24 weeks and >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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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