Azithromycin versus Erythromycin as a part of antibiotic prophylaxis in patients of PPROM and their relation with latency period and intrauterine infectio
Phase 3
- Conditions
- Health Condition 1: O429- Premature rupture of membranes, unspecified as to length of time between rupture and onset of labor
- Registration Number
- CTRI/2024/07/070762
- Lead Sponsor
- Dept of Obstetrics and Gynaecology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with rupture of membranes from 24 weeks to 33 weeks + 6 days gestation
Exclusion Criteria
1.Patients with established clinical chorioamnionitis on presentation
2.Conditions requiring ‘intentional delivery’ in PPROM
3.IUD or any lethal fetal congenital anomaly
4.Cord accidents
5.Multiple gestation
6.Patients who have received other antibiotics before presentation
7.Patients in active labour
8.Patients with cervical cerclage in situ
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To compare the efficacy of a single dose of 1 g intravenous azithromycin to the 7-day course of 250 mg per oral erythromycin QID as a part of antibiotic prophylaxis in patients of PPROM (both regimen including a 2-day course of intravenous ampicillin followed by a 5-day course of per oral amoxicillin) with respect to the following outcomes: <br/ ><br>a.Duration of latency period <br/ ><br>b.Incidence of chorioamnionitis <br/ ><br>Timepoint: followup of 6 weeks post partum
- Secondary Outcome Measures
Name Time Method 2.To compare both regimens in terms of the following outcome parameters: <br/ ><br>a.Rates of Caesarean section <br/ ><br>b.Incidence of meconium-stained amniotic fluid (MSAF) <br/ ><br>c.Incidence of neonatal sepsis <br/ ><br>d.Incidence of postpartum endometritis <br/ ><br>Timepoint: followup of 6 weeks postpartum