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Impact of Antichlamydial Treatment on the Rate of Preeclampsia

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ClinicalTrials.gov Identifier: NCT03233880
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
ADEL SHAFIK SALAH EL-DIN, Ain Shams Maternity Hospital

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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Drug: Azithromycin 1gm Other: PLACEBO Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double blinded controlled trial
Masking: Double (Participant, Care Provider)
Masking Description: double blind
Primary Purpose: Prevention
Official Title: Impact of Antichlamydial Treatment on the Rate of Preeclampsia Among Egyptian Primigravidae: a Randomized Controlled Trial
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


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 Name: anti chlamydial treatment

Placebo Comparator: placebo group
- Matching placebo orally, single dose
Other: PLACEBO
placebo




Primary Outcome Measures :
  1. Pre eclampsia [ Time Frame: after 20 weeks ]
    develpment of pre eclampsia


Secondary Outcome Measures :
  1. preterm labour [ Time Frame: less than completed 37 weeks ]
    early delivery before term



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233880


Contacts
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Contact: Adel S Salah El-Din, MD 01005223586 shafikadel@hotmail.com

Locations
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Egypt
Ain Shams University Maternity Hospital Recruiting
Cairo, Egypt
Contact: adel S salah el-din, MD    01005223586    shafikadel@hotmail.com   
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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Principal Investigator: Adel S Salah El-Din, MD Assistant Proffesor

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Responsible Party: ADEL SHAFIK SALAH EL-DIN, Assistant professor, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT03233880     History of Changes
Other Study ID Numbers: Anti Chlamydial treatment
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ADEL SHAFIK SALAH EL-DIN, Ain Shams Maternity Hospital:
chlamydia
prevention

Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications