Azithromycin versus Erythromycin as a part of antibiotic prophylaxis in patients of PPROM and their relation with latency period and intrauterine infection

Single dose intravenous azithromycin versus multiple dose oral erythromycin as a part of antibiotic prophylaxis in management of PPROM and their relation with latency period and chorioamnionitis - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070762

Enrollment

200

Registered

2024-07-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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: Intravenous Azithromycin: Intravenous Azithromycin 1 gram stat Control Intervention1: Oral Erythromycin: Oral Erythromycin 250 mg QID for 7 days

Eligibility

Inclusion criteria

Inclusion criteria: Patients with rupture of membranes from 24 weeks to 33 weeks + 6 days gestation

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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: a.Duration of latency period b.Incidence of chorioamnionitis Timepoint: followup of 6 weeks post partum	—

Measure

Time frame

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: a.Duration of latency period b.Incidence of chorioamnionitis Timepoint: followup of 6 weeks post partum

—

Secondary

Measure	Time frame
2. To compare both regimens in terms of the following outcome parameters: a. Rates of Caesarean section b. Incidence of meconium-stained amniotic fluid (MSAF) c. Incidence of neonatal sepsis d. Incidence of postpartum endometritis Timepoint: followup of 6 weeks postpartum	—

Countries

India

Contacts

Public ContactProf Seema Hakim

Jawaharlal Nehru Medical College Hospital

drseemahakim@rediffmail.com9410643435

Outcome results

None listed

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