Azithromycin for Preterm Pre-labor Rupture of Membranes

April 23, 2024 updated by: Mohammed Khairy Ali, Assiut University

Different Azithromycin Protocols for Management of Preterm Pre-labor Rupture of Membranes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Women Health Hospital - Assiut university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Azithromycin 1 day group
Patients will receive Azithromycin 1000mg once orally
Drug: Azithromycin
Patients will receive Azithromycin orally 1000 mg
Drug: Ampicillin
All patients will receive Ampicillin 2gm IV every 6 hours for 2 days
Drug: Azithromycin
Azithromycin 500 mg orally once
Drug: Azithromycin
Azithromycin 250 mg orally daily for 4 days
Other: Azithromycin 5 days group
Patients will receive Azithromycin 500mg once orally, followed by Azithromycin 250mg orally daily for 4 days
Drug: Azithromycin
Patients will receive Azithromycin orally 1000 mg
Drug: Ampicillin
All patients will receive Ampicillin 2gm IV every 6 hours for 2 days
Drug: Azithromycin
Azithromycin 500 mg orally once
Drug: Azithromycin
Azithromycin 250 mg orally daily for 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Days from diagnosis of preterm pre-labor rupture of membranes to delivery.
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 17, 2019

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-PROM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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