Impact of Antichlamydial Treatment on the Rate of Preeclampsia

Impact of Antichlamydial Treatment on the Rate of Preeclampsia Among Egyptian Primigravidae: a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Drug: Azithromycin 1gm; Other: PLACEBO

Detailed Description

Preeclampsia complicates approximately 5-8% of all pregnancies and is a major cause of maternal morbidity and mortality worldwide.Its progress differs among patients; most cases are diagnosed pre-term. Preeclampsia may also occur up to six weeks post-partum. The present study included 1200 primigravidae who attended the outpatient clinic of Ain Shams University maternity Hospital in Cairo, Egypt, for routine antenatal care between July 2016 and September 2017. The study was approved by the Ethics Committee of Ain Shams University Maternity Hospital in accordance with local research governance requirements. All participating women signed an informed consent form inclusion criteria were a primigravida, singleton pregnancy, maternal age 18-35 years, and pregnancy duration 16-20 weeks at the time of study inclusion. Exclusion criteria were Women with multi-fetal pregnancy, diabetes mellitus, chronic hypertension, or chronic renal disease.Computer based Randomization codes were placed in sequentially numbered, opaque, sealed envelopes by an observer, to be opened at time of enrollment by a pharmacist in Ain Shams University Hospital who prepared the study drug and had no further involvement with the patient's care. All data were analyzed before it was determined which group was received azithromycin and which was received placebo.

• Azithromycin 1Gm orally, single dose (Xithrone 500 mg two tablets, Amoun, Inc, Cairo, Egypt) Group (A) OR
• Matching placebo orally, single dose Group (B). Preeclampsia was defined in the terms of hypertension and proteinuria. The International Society for the Study of Hypertension (ISSH) defined preeclampsia as new hypertension and new proteinuria developing after 20 weeks of gestation and regressing remotely after delivery. Hypertension is defined as diastolic arterial blood pressure ≥90 mmHg on two or more consecutive occasions, at least 4 hours apart. Proteinuria is defined as ≥ +1 on dipstick test on 2 midstream urine collections more than 4 hours apart or 24-hour urinary protein ≥ 300mg. Severe preeclampsia was defined as follows: blood pressure >160/110 mmHg on two occasions at least 6 hours apart, proteinuria >5 gm/24 hours, oliguria < 500 ml/24 hours, thrombocytopenia < 100.000/ml, cerebral visual disturbances, epigastric pain, nausea and vomiting, impaired liver function of unclear etiology or the occurrence of complications as pulmonary edema, accidental hemorrhage or fetal compromise.

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: adel S salah el-din, MD; Phone Number: 01005223586; Email: shafikadel@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain shams university maternity hospital
    • Contact: adel S salah el-din, MD; Phone Number: 01005223586; Email: shafikadel@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• primigravida, singleton pregnancy, maternal age 18-35 years, and pregnancy duration 16-20 weeks at the time of study inclusion.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Azithromycin group; 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; Azithromicin 1 gm oral single dose; Other Names: anti chlamydial treatment
Placebo Comparator: placebo group; - Matching placebo orally, single dose	Other: PLACEBO; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre eclampsia	develpment of pre eclampsia	after 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preterm labour	early delivery before term	less than completed 37 weeks

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Principal Investigator: Adel S Salah El-Din, MD, Assistant Proffesor

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: July 23, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: prevention; chlamydia
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: Anti Chlamydial treatment

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