NCT03233880

Brief Summary

This randomized, double blinded controlled trial included 1200 healthy primigravidae who attended an outpatient clinic at 16-20weeks of pregnancy. All women were randomly divided equally into two groups, group A(600 women) who received antichlamydial treatment in the form of azithromycin 1 gram single oral dose before 20 weeks of pregnancy and group B (600 women) who received no treatment(placebo). All participants were followed up for up to 6 weeks postpartum and observed for the development of preeclampsia.

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
1,200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2016

Typical duration for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

2.1 years

First QC Date

July 23, 2017

Last Update Submit

June 26, 2018

Conditions

Pre-Eclampsia

Keywords

chlamydiaprevention

Outcome Measures

Primary Outcomes (1)

  • Pre eclampsia

    develpment of pre eclampsia

    after 20 weeks

Secondary Outcomes (1)

  • preterm labour

    less than completed 37 weeks

Study Arms (2)

Azithromycin group

ACTIVE COMPARATOR

Azithromycin 1Gm orally, single dose (Xithrone 500 mg two tablets, Amoun, Inc, Cairo, Egypt) will be given to pregnant women at 16/20 weeks of pregnancy

Drug: Azithromycin 1gm

placebo group

PLACEBO COMPARATOR

\- Matching placebo orally, single dose

Other: PLACEBO

Interventions

Azithromycin 1gmDRUG

Azithromicin 1 gm oral single dose

Also known as: anti chlamydial treatment
Azithromycin group
PLACEBOOTHER

placebo

placebo group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Women with multi-fetal pregnancy, diabetes mellitus, chronic hypertension, or chronic renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pre-EclampsiaChlamydia Infections

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesChlamydiaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital Diseases

Study Officials

  • Adel S Salah El-Din, MD

    Assistant Proffesor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adel S Salah El-Din, MD

CONTACT

01005223586shafikadel@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
double blind
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized, double blinded controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 23, 2017

First Posted

July 31, 2017

Study Start

July 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

EG(1)