Azithromycin for Preterm Pre-labor Rupture of Membranes

NCT04202380 | Completed

• 1 other identifier: A-PROM
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Pre-labor Rupture of Membranes

Outcome Measures

Primary Outcomes (1)

• Days from diagnosis of preterm pre-labor rupture of membranes to delivery.

  14 days

Study Arms (2)

Azithromycin 1 day group

OTHER

Patients will receive Azithromycin 1000mg once orally

Drug: Azithromycin; Drug: Ampicillin

Azithromycin 5 days group

OTHER

Patients will receive Azithromycin 500mg once orally, followed by Azithromycin 250mg orally daily for 4 days

Drug: Azithromycin; Drug: Ampicillin

Interventions

Azithromycin DRUG

Patients will receive Azithromycin orally 1000 mg

Azithromycin 1 day group; Azithromycin 5 days group

Ampicillin DRUG

All patients will receive Ampicillin 2gm IV every 6 hours for 2 days

Azithromycin 1 day group; Azithromycin 5 days group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

Related Publications (1)

• Abdelfattah LE, Aboshama RA, Abdelbadie AS, Abulhasan MH, Anan MA, Abdelaal II. Different azithromycin protocols for management of preterm prelabour rupture of membranes: a randomized clinical trial. BMC Pregnancy Childbirth. 2022 Nov 23;22(1):869. doi: 10.1186/s12884-022-05189-7.

  PMID: 36424542 DERIVED

MeSH Terms

Interventions

Azithromycin; Ampicillin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 17, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2021
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

EG (1)