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.
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.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Maternity Hospital
Cairo
adel S salah el-din, MD, 01005223586, shafikadel@hotmail.com
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Azithromycin 1gm |
| placebo group | Placebo 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.
Pre eclampsia
develpment of pre eclampsia
Measured: after 20 weeks
Secondary outcomes (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.
- First posted31 Jul 2017
- Study start1 Jul 2016
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ADEL SHAFIK SALAH EL-DIN, Ain Shams Maternity Hospital
- Investigators
- Adel S Salah El-Din, MD, Principal investigator, Assistant Proffesor
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Antichlamydial Treatment on the Rate of Preeclampsia Among Egyptian Primigravidae: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03233880
- Acronym / sponsor ID
- Anti Chlamydial treatment
- Conditions
- Pre-Eclampsia
- Keywords
- chlamydia, prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- randomized, double blinded controlled trial
| Arm | Type | Receives |
|---|---|---|
| Azithromycin group | Active comparator | Drug: Azithromycin 1gmAzithromycin 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 |
| placebo group | Placebo comparator | Other: PLACEBO- Matching placebo orally, single dose |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- primigravida, singleton pregnancy, maternal age 18-35 years, and pregnancy duration 16-20 weeks at the time of study inclusion.
Key exclusion criteria (1 listed)
- Women with multi-fetal pregnancy, diabetes mellitus, chronic hypertension, or chronic renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin 1gmAlso: anti chlamydial treatmentAzithromicin 1 gm oral single dose | Drug | Azithromycin group |
| PLACEBOplacebo | Other | placebo group |
Primary outcome
Pre eclampsia
Time frame: after 20 weeks
develpment of pre eclampsia
1 secondary outcome
preterm labour
Time frame: less than completed 37 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Pre-Eclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adel S Salah El-Din, MD principal investigator
Assistant Proffesor
1 site in 1 country: see every site and its status.
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.