NCT05971654

Brief Summary

The aim of this study is to evaluate the benefit of the addition of azithromycin to standard treatments to prolong pregnancy in women having intact membranes and is at risk of or in preterm labour.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

July 30, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

July 25, 2023

Last Update Submit

July 25, 2023

Conditions

Preterm Labor

Keywords

preterm deliveryAzithromycin

Outcome Measures

Primary Outcomes (1)

  • Gestational age at time of delivery

    measured in week's days'number

    9 months

Study Arms (2)

Azithromycin

EXPERIMENTAL

azithromycin.:500 mg PO once for 5 days every month

Drug: azithromycin

control

NO INTERVENTION

pregnant woman at risk of preterm delivery

Interventions

azithromycinDRUG

azithromycin.:500 mg PO once for 5 days every month

Also known as: zisrocin
Azithromycin

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \< Pregnancy \<37 weeks of gestation.
  • Threat or history of preterm labour.
  • Preterm labour itself (Non established)

You may not qualify if:

  • antibiotics use within 14 days (except for pericerclage prophylaxis, or streptococcus B prophylaxis);
  • PPROM; and fetal extraction required \<37 weeks.
  • Current or past history of medical diseases (Diabetes Milletus, Hypertension, Systemic Lupus Erythematosus, Cardiac diseases, etc ).
  • Adverse perinatal outcome due to abdominal trauma.
  • Structural fetal anomalies detected during anomaly scan.
  • Allergy to Azithromycin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

MeSH Terms

Conditions

Obstetric Labor, PrematurePremature Birth

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 2, 2023

Study Start

July 30, 2023

Primary Completion

September 30, 2023

Study Completion

May 30, 2024

Last Updated

August 2, 2023

Record last verified: 2023-07

Locations

EG(1)