Azithromycin for Preterm Pre-labor Rupture of Membranes

Not Applicable

Completed

• Conditions: Preterm Pre-labor Rupture of Membranes
• Interventions: Drug: Azithromycin; Drug: Ampicillin

• Registration Number: NCT04202380
• Lead Sponsor: Assiut University

Brief Summary

The preterm prelabour rupture of membranes is defined as the spontaneous rupture of the fetal membranes before 37 completed weeks. Preterm prelabour rupture of membranes complicates up to 3% of pregnancies and is associated with 30-40% of preterm births. preterm prelabour rupture of membranes can result in significant neonatal morbidity and mortality, primarily from prematurity, sepsis, cord prolapse, and pulmonary hypoplasia. In addition, there are risks associated with chorioamnionitis and placental abruption The diagnosis of spontaneous rupture of the membranes is made by maternal history followed by a sterile speculum examination. If on speculum examination, no amniotic fluid is observed, clinicians should consider performing an insulin-like growth factor-binding protein-1 or placental alpha microglobulin-1 test of vaginal fluid to guide further management.

One of the risks associated with preterm prelabour rupture of membranes is ascending infection leading to chorioamnionitis, and subsequent fetal and neonatal infection.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-17
• Study Start: 2020-01-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. Gestational age is between 28 wks and 37wks
2. Singleton living pregnancy.
3. Confirmed Premature Pre-labor rupture of membranes (PPROM).

Exclusion Criteria

1. previable rupture of membranes (<23+6wks)
2. Multiple gestations
3. Macrolide allergy
4. patient receiving combination macrolide therapy
5. lethal fetal anomalies
6. contraindications to expectant management of PPROM at time of diagnosis e.g. concurrent preterm labor, placental abruption, chorioamnionitis or non-reassuring fetal testing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azithromycin 1 day group	Ampicillin	Patients will receive Azithromycin 1000mg once orally
Azithromycin 5 days group	Ampicillin	Patients will receive Azithromycin 500mg once orally, followed by Azithromycin 250mg orally daily for 4 days
Azithromycin 5 days group	Azithromycin	Patients will receive Azithromycin 500mg once orally, followed by Azithromycin 250mg orally daily for 4 days
Azithromycin 1 day group	Azithromycin	Patients will receive Azithromycin 1000mg once orally

Primary Outcome Measures

Name	Time	Method
Days from diagnosis of preterm pre-labor rupture of membranes to delivery.	14 days

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt