Comparison of azithromycin and erythromycin effect in reducing complications of preterm premature rupture of membranes: a clinical trial study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230129057268N1

Enrollment

Registered

2023-02-11

Start date

2023-02-09

Completion date

Unknown

Last updated

2023-03-13

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

Conditions

preterm premature rupture of membranes (PPROM).

Interventions

Intervention 1: This study is a randomized clinical trial. group A (n=30), PPROM patients with a gestational age more than 24 weeks will treat with 1000 mg azithromycin orally as a single dose. Aditio

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Women with a gestational age of more than 24 weeks will be included in this study.

Exclusion criteria

Exclusion criteria: Women with a gestational age of less than 24 weeks, women with a cerclage, history of smoking, trauma or injury that led to PPROM , a congenital or fatal fetal anomaly, and those that consumed other antibiotics before referral, will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
Latency period. Timepoint: The interval between the rupture of the membranes and the onset of labor. Method of measurement: Length of latency was calculated in days by subtracting the time of delivery from the time of membrane rupture.;Clinical chorioamnionitis. Timepoint: Before delivery. Method of measurement: Clinical chorioamnionitis will be determined by clinical symptoms including fever and tachycardia and .;Type of delivery. Timepoint: Delivery time. Method of measurement: Observation.;Amniotic fluid with meconium. Timepoint: Before delivery. Method of measurement: Amniotic fluid stained with meconium will be determined by clinical symptoms such as fetal distress, observation of meconium discharged from amniotic fluid.;Postpartum endometritis. Timepoint: 48 to 72 hours after delivery. Method of measurement: Postpartum endometritis will be determined by the mother's fever, mother's abdominal pain, mother's unpleasant odor secretions.;Neonatal sepsis. Timepoint: 72 hours after birth. Method of measurement: Neonatal sepsis will be determined by ?lood culture.;Neonatal mortality. Timepoint: After delivery. Method of measurement: Observation.	—

Measure

Time frame

Latency period. Timepoint: The interval between the rupture of the membranes and the onset of labor. Method of measurement: Length of latency was calculated in days by subtracting the time of delivery from the time of membrane rupture.;Clinical chorioamnionitis. Timepoint: Before delivery. Method of measurement: Clinical chorioamnionitis will be determined by clinical symptoms including fever and tachycardia and .;Type of delivery. Timepoint: Delivery time. Method of measurement: Observation.;Amniotic fluid with meconium. Timepoint: Before delivery. Method of measurement: Amniotic fluid stained with meconium will be determined by clinical symptoms such as fetal distress, observation of meconium discharged from amniotic fluid.;Postpartum endometritis. Timepoint: 48 to 72 hours after delivery. Method of measurement: Postpartum endometritis will be determined by the mother's fever, mother's abdominal pain, mother's unpleasant odor secretions.;Neonatal sepsis. Timepoint: 72 hours after birth. Method of measurement: Neonatal sepsis will be determined by ?lood culture.;Neonatal mortality. Timepoint: After delivery. Method of measurement: Observation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtiye Javaheri

Yazd University of Medical Sciences

atiyeh56@gmail.com38203414

Outcome results

None listed

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