Antenatal Azithromycin to Prevent Preterm Birth in Pregnant Women With Vaginal Cerclage

NCT04278937 | Completed Phase 4

• 1 other identifier: FMASU 1304/2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In women with indicated vaginal cerclage, this study aims to assess the efficacy of antenatal prophylactic Azithromycin in preventing preterm labor.

Conditions

Preterm Birth

Keywords

cerclage; azithromycin

Outcome Measures

Primary Outcomes (1)

• Gestational age at time of delivery

  the gestational age measured in weeks

  At time of delivery

Secondary Outcomes (3)

• Birth weight

  At time of delivery

• Neonatal complications

  At time of delivery and in the first postpartum week

• Maternal complications

  At time of delivery and in the first postpartum week

Study Arms (2)

Azithromycin group

ACTIVE COMPARATOR

women will receive 500mg Azithromycin (Zithrokan®, Hikma, Egypt) one tablet orally twice daily for three days in 3 courses at 14 weeks, 24 weeks and 32 weeks in addition to routine usual antenatal care.

Drug: Azithromycin Tablets

Control group

NO INTERVENTION

women will receive routine antenatal care without antibiotic prophylaxis after cerclage.

Interventions

Azithromycin Tablets DRUG

one tablet orally twice daily for three days in 3 courses at 14 weeks, 24 weeks and 32 weeks

Also known as: Zithrokan®

Azithromycin group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gestational age (14-34 weeks).
• Pregnant women who underwent vaginal cerclage (either history- based or ultrasound based vaginal cerclage)
• History based cerclage:
• History of one or more second-trimester pregnancy losses related to painless cervical dilatation and in absence of labor or abruptio placentae; OR
• Prior cerclage due to painless cervical dilation in the second trimester
• Ultrasound based cerclage:
• Current singleton pregnancy, prior spontaneous preterm birth at less than 34 weeks of gestation, and short cervical length (less than 25 mm) before 24 weeks of gestation

You may not qualify if:

• Multiple pregnancy.
• 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

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

Related Publications (1)

• Ahmed RHM, Bayoumy HA, Ashoush SA, Gabr WKL. Antenatal azithromycin to prevent preterm birth in pregnant women with vaginal cerclage: A randomized clinical trial. Turk J Obstet Gynecol. 2023 Mar 10;20(1):1-7. doi: 10.4274/tjod.galenos.2023.47715.

  PMID: 36907997 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Sherif A Ashoush, MD

  Professor

  STUDY DIRECTOR

• Hassan A Bayoumy, MD

  Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 20, 2020
• Study Start: April 15, 2019
• Primary Completion: February 15, 2020
• Study Completion: April 15, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

EG (1)