Impact of Antichlamydial Treatment on the Rate of Preeclampsia

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03233880
• Other study ID #: Anti Chlamydial treatment
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2016
• Est. completion date: August 1, 2018

Study information

• Verified date: June 2018
• Source: Ain Shams Maternity Hospital
• Contact: Adel S Salah El-Din, MD
• Phone: 01005223586
• Email: shafikadel[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Drug:
• Azithromycin 1gm
Azithromicin 1 gm oral single dose

Other:
• PLACEBO
placebo

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre eclampsia	develpment of pre eclampsia	after 20 weeks
Secondary	preterm labour	early delivery before term	less than completed 37 weeks