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Comparison of the Effectiveness of Azithromycin and Erythromycin on the rate of clinical chorioamnionitis and Latency period up to termination of pregnancy in women with Preterm Premature Rupture of Membrane pregnancy

Comparison of the Effectiveness of Azithromycin and Erythromycin on the rate of clinical chorioamnionitis and Latency period up to termination of pregnancy in women with Preterm Premature Rupture of Membrane pregnancy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240513061769N1
Enrollment
120
Registered
2024-05-23
Start date
2024-05-25
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Condition 1: Premature Rupture of Amniotic Membranes. Condition 2: Chorioamnionitis. Preterm premature rupture of membranes, unspecified as to length of time between rupture and onset of labor Chorioamnionitis, second trimester

Interventions

Intervention 1: Intervention group: They will be given 1000 mg of oral azithromycin (Two 500 mg tablets) as a single dose and 2 gr of intravenous ampicillin every 6 hours for 48 hours, followed by 500

Sponsors

Zanjan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Gestational age between 26 and 34 weeks Singleton pregnancy Confirmed Premature rupture of the water sac A live fetus

Exclusion criteria

Exclusion criteria: The presence of any other infection in the mother that requires antibiotic therapy Fetal congenital anomaly Delivery within 24 hours after receiving antibiotics Hypersensitivity to ampicillin, erythromycin, or azithromycin

Design outcomes

Primary

MeasureTime frame
Clinical chorioamnionitis. Timepoint: Before the start of the intervention, After the start of the intervention until the time the fetus is completely removed from the uterus. Method of measurement: Fever above 38 degrees Celsius, Fetal Tachycardia, Maternal Tachycardia above 100 beats per minute, Increased WBC Count in the mother's serum to more than 15000 c/mm, or Discharge of purulent fluid from the vagina.

Secondary

MeasureTime frame
The period of delay until the childbirth. Timepoint: Every hour until the time of delivery of the fetus. Method of measurement: The elapsed time from the rupture of the water sac to the childbirth of the fetus in hours.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtena Alavi

Zanjan University of Medical Sciences

alaviatena@gmail.com+98 24 3313 0000

Outcome results

None listed

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