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Pre-EclampsiaPhase 4NCT03233880

Impact of Antichlamydial Treatment on the Rate of Preeclampsia

A Phase 4 study testing Azithromycin 1gm in people with Pre-Eclampsia, run by Ain Shams Maternity Hospital at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pre-Eclampsia
What is being tested?
Azithromycin 1gm
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,200 participants
Where
1 siteEgypt
Study dates
1 Jul 2016to 1 Aug 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Adel S Salah El-Din, MD contact

01005223586

shafikadel@hotmail.com

Egypt1 site, 1 recruiting
  • Ain Shams University Maternity Hospital

    Cairo

    adel S salah el-din, MD, 01005223586, shafikadel@hotmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read the 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.
Conditions
Pre-Eclampsia
Being tested
Azithromycin 1gm, PLACEBO
Keywords
chlamydia, prevention
Medical subject headings
Pre-Eclampsia, Chlamydia Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azithromycin 1gmDrug

    Also called anti chlamydial treatment

    Azithromicin 1 gm oral single dose

  • PLACEBOOther

    placebo

Study groups in NCT03233880
Study groupRoleWhat they receive
Azithromycin groupActive comparatorAzithromycin 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
Receives: Drug: Azithromycin 1gm
placebo groupPlacebo comparator- Matching placebo orally, single dose
Receives: Other: PLACEBO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre eclampsia

    develpment of pre eclampsia

    Measured: after 20 weeks

Secondary outcomes (1)
  1. preterm labour

    early delivery before term

    Measured: less than completed 37 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2017
  2. Study start1 Jul 2016
  3. Primary completion1 Aug 2018 (estimated)
  4. Study completion1 Aug 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, double blinded controlled trial
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03233880
Sponsor's protocol ID
Anti Chlamydial treatment
Status last verified
Jun 2018
First submitted
23 Jul 2017
Last updated
28 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Azithromycin 1gm in people with Pre-Eclampsia, run by Ain Shams Maternity Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Adel S Salah El-Din, MD (01005223586, shafikadel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre eclampsia (time frame: after 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.

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