Pregnant With ComplicationNCT05465304
Effect of Azithromycin in Preventing Premature Labour
An observational study of Pregnant With Complication, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This is a prospective observational case controlled study. The control group will include pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 32 years, women only
- Conditions the study is for
- Pregnant With Complication
- What is being tested?
- Azithromycin
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 30 Apr 2022
- Phase
- Observational
- 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 32 years
- Women only
- Adult
Study population: Randomized Controlled prospective study
Who may be able to join
- Pregnant women with <34 weeks of gestation,
- Hospitalization for risk of preterm labour,
- Threat of preterm labour, or preterm labour itself.
- Threat of preterm labour and preterm labour will have to be diagnosis cited in the medical record by the physician.
- Women at risk of preterm labour must have one of the following conditions cited in their record: sludge, short cervix, cerclage, or bulging membranes
Who cannot join
- Patients were excluded from the current study in case of the use of antibiotics within 14 days before the admission (except for pericerclage prophylaxis, or streptococcus B prophylaxis), PPROM or fetal extraction required <37 weeks.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni-Suef University teaching Hospital
Banī Suwayf, Beni Suweif Governorate, 62511
About this study
Official title: Effect of Azithromycin on Pregnancy Prolongation in Women at Risk for Premature Labour
This is a prospective observational case controlled study. The control group will include pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy.
The test group will involve pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin
Read the detailed description
A prospective randomized clinical study was conducted in the outpatient clinic of the gynecology department of Beni Suef University Hospital, Beni-Suef, Egypt, between October 01, 2021, and April 30, 2022. The study included 211 pregnant women aged between 20 to 41 years. These patients were randomized into three groups.
The first group which was the control group, included pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments (progesterone) for prolongation of pregnancy. While the second group which was the first test group, involved pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin for 5 days every month.
. The third group was the second test group in which the pregnant women administerated Azithromycin and clindamycin (Dalacin®) vaginal gel 5 times per month.
- Conditions
- Pregnant With Complication
- Being tested
- Azithromycin
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
The assessment of efficacy of azithromycin in preventing premature labour.The duration between administrating azithromycin as monotherapy and polytherapy and labour is calculated
| Study group | Role | What they receive |
|---|---|---|
| Control group | control group, included pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments (progesterone) for prolongation of pregnancy. | |
| Azithromycin group | the first test group, involved pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin for 5 days every month Receives: Drug: Azithromycin | |
| Azithromycin plus Clindamycin group | the second test group in which the pregnant women administerated Azithromycin and clindamycin (Dalacin®) vaginal gel 5 times per month. Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Azithromycin in preventing premature labour
Main outcome was the number of days between diagnosis and composite event, defined as delivery or rupture of membranes or 2nd intervention aimed at prolonging pregnancy (such as cerclage or tocolysis) or censure (maternal death or transfer). The three groups were compared regarding this number of days
Measured: 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Oct 2021
- Primary completion1 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant With ComplicationStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghda R.S. Hussein, Beni-Suef University
- Investigators
- Raghda R.S Hussein, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465304
- Sponsor's protocol ID
- REC-H-PhBSU-21022
- Status last verified
- May 2023
- First submitted
- 15 Jul 2022
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pregnant women with risk for pre mature labour will adiminster azithromycin as monotherapy or polytherapy with clindamycin vaginal cream ,The efficacy of Azithromycin in preventing premature mature labour will be assessed
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Azithromycin on Pregnancy Prolongation in Women at Risk for Premature Labour
- ClinicalTrials.gov ID
- NCT05465304
- Acronym / sponsor ID
- REC-H-PhBSU-21022
- Conditions
- Pregnant With Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 19 Jul 2022 (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 is a prospective observational case controlled study. The control group will include pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy.
The test group will involve pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin
Detailed description
A prospective randomized clinical study was conducted in the outpatient clinic of the gynecology department of Beni Suef University Hospital, Beni-Suef, Egypt, between October 01, 2021, and April 30, 2022. The study included 211 pregnant women aged between 20 to 41 years. These patients were randomized into three groups.
The first group which was the control group, included pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments (progesterone) for prolongation of pregnancy. While the second group which was the first test group, involved pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin for 5 days every month.
. The third group was the second test group in which the pregnant women administerated Azithromycin and clindamycin (Dalacin®) vaginal gel 5 times per month.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –control group, included pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments (progesterone) for prolongation of pregnancy. |
| Azithromycin group | – | Drug: Azithromycinthe first test group, involved pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin for 5 days every month |
| Azithromycin plus Clindamycin group | – | Drug: Azithromycinthe second test group in which the pregnant women administerated Azithromycin and clindamycin (Dalacin®) vaginal gel 5 times per month. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Randomized Controlled prospective study
Key inclusion criteria (5 listed)
- Pregnant women with <34 weeks of gestation,
- Hospitalization for risk of preterm labour,
- Threat of preterm labour, or preterm labour itself.
- Threat of preterm labour and preterm labour will have to be diagnosis cited in the medical record by the physician.
- Women at risk of preterm labour must have one of the following conditions cited in their record: sludge, short cervix, cerclage, or bulging membranes
Key exclusion criteria (1 listed)
- Patients were excluded from the current study in case of the use of antibiotics within 14 days before the admission (except for pericerclage prophylaxis, or streptococcus B prophylaxis), PPROM or fetal extraction required <37 weeks.
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 |
|---|---|---|
| AzithromycinThe assessment of efficacy of azithromycin in preventing premature labour.The duration between administrating azithromycin as monotherapy and polytherapy and labour is calculated | Drug | Azithromycin group, Azithromycin plus Clindamycin group |
Primary outcome
Effect of Azithromycin in preventing premature labour
Time frame: 6 monthes
Main outcome was the number of days between diagnosis and composite event, defined as delivery or rupture of membranes or 2nd intervention aimed at prolonging pregnancy (such as cerclage or tocolysis) or censure (maternal death or transfer). The three groups were compared regarding this number of days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No. Pregnant women with risk for pre mature labour will adiminster azithromycin as monotherapy or polytherapy with clindamycin vaginal cream ,The efficacy of Azithromycin in preventing premature mature labour will be assessed
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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.
Raghda R.S Hussein principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant With Complication, run by Beni-Suef University 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 5 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: finished, as of the sponsor's last update on 17 May 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Azithromycin in preventing premature labour (time frame: 6 monthes). 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 17 May 2023.