Antibiotics Causing Adverse Effects in Therapeutic UsePhase 4NCT05040334
Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation
A Phase 4 study testing Group 1: Antibiotic receiving group in people with Antibiotics Causing Adverse Effects in Therapeutic Use, run by Cairo University at 1 site in Egypt.
Trial summary
To determine the role of antibiotic prophylaxis in the surgical management of miscarriage. 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
- Antibiotics Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Group 1: Antibiotic receiving group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 May 2022
- 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
- Maternal age :18-35 years
- Gestational age: up to 12 6/7 weeks of gestation (confirmed by a reliable date for the last menstrual period or /and 1st trimester ultrasound scan).
- Singleton miscarriage
- Type of miscarriage: Incomplete or Missed miscarriage
- Surgical evacuation will be done within 2 weeks of diagnosis of miscarriage .
Who cannot join
- Maternal age: younger than 18 years
- Induced miscarriage of pregnancy
- Septic miscarriage
- Evidence of infection
- Morbid obesity (BMI≥40kg/m2)
- Allergy to prophylactic antibiotics (i.e., doxycycline or metronidazole)
- Antibiotics use within 7 days before randomization
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Kasr Al-Ainy University Hospital, Cairo University.
Cairo
Marwa Mo Eid, Ass prof, 01001225079, marwameid2014@gmail.com
Nihal Mo El-Demiry, Lecturer, : 01006049052, n.eldemiry@gmail.com
About this study
To determine the role of antibiotic prophylaxis in the surgical management of miscarriage.
Read the detailed description
Patients will be randomized to receive either prophylactic antibiotic [a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)] or placebo using identical sealed envelopes.Included cases are those with early miscarriage (within the first trimester 12 6/7 weeks of gestation) , missed or incomplete miscarriage, undergoing surgical management will be included in the study.
Technique:
The investigators will prepare 138 identical envelops, half of them filled with a label group(1) who are the group to receive the antibiotic prophylaxis with all instruction details, while the other half filled with a label identifying ( group 2) who are the placebo group. All envelops will be prepared by the investigator and sealed before starting enrollment. After enrollment, each participant will be allowed to choose one envelop to determine to which group the patient will be assigned to.
- Being tested
- Group 1: Antibiotic receiving group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: Antibiotic receiving groupDrug
Also called Group 2 :placebo receiving group
Group 1; receiving antibiotic prophylaxis; single dose of oral doxycycline (200 mg) tablet and metronidazole (500 mg) tablet 2 hours before the surgical evacuation Group B ;receiving placebo 2 hours before the surgical evacuation
| Study group | Role | What they receive |
|---|---|---|
| group(1) | Active comparator | 69 patients receiving a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)tablets Receives: Drug: Group 1: Antibiotic receiving group |
| Group (2) | Placebo comparator | 69 patients receiving placebo Receives: Drug: Group 1: Antibiotic receiving group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pelvic infection after surg ical evacuation of miscarriage with use of antibiotic prophylaxis.
White cell count >12 *10^9 cells / L by CBC
Measured: 2 weeks from surgery
Secondary outcomes (1)
Change in the risk of severe puerperal sepsis following the surgical procedure
Signs of puerperal sepsis in form of puerperal pyrexia >38 C and/or purulent vaginal discharge
Measured: 2 weeks from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Jan 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotics Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1;receiving antibiotic prophylaxis Group 2; Not receiving antibiotics
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Mahmoud Eid, Cairo University
- Investigators
- Marwa Mo Eid, Ass.prof., Study director, Cairo UniversityNihal Mo El-Demiry, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040334
- Sponsor's protocol ID
- Cairo University Obygyn
- Status last verified
- Mar 2022
- First submitted
- 14 Aug 2021
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation
- ClinicalTrials.gov ID
- NCT05040334
- Acronym / sponsor ID
- Cairo University Obygyn
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 10 Sep 2021 (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.
To determine the role of antibiotic prophylaxis in the surgical management of miscarriage.
Detailed description
Patients will be randomized to receive either prophylactic antibiotic [a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)] or placebo using identical sealed envelopes.Included cases are those with early miscarriage (within the first trimester 12 6/7 weeks of gestation) , missed or incomplete miscarriage, undergoing surgical management will be included in the study.
Technique:
The investigators will prepare 138 identical envelops, half of them filled with a label group(1) who are the group to receive the antibiotic prophylaxis with all instruction details, while the other half filled with a label identifying ( group 2) who are the placebo group. All envelops will be prepared by the investigator and sealed before starting enrollment. After enrollment, each participant will be allowed to choose one envelop to determine to which group the patient will be assigned to.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group 1;receiving antibiotic prophylaxis Group 2; Not receiving antibiotics
| Arm | Type | Receives |
|---|---|---|
| group(1) | Active comparator | Drug: Group 1: Antibiotic receiving group69 patients receiving a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)tablets |
| Group (2) | Placebo comparator | Drug: Group 1: Antibiotic receiving group69 patients receiving placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Maternal age :18-35 years
- Gestational age: up to 12 6/7 weeks of gestation (confirmed by a reliable date for the last menstrual period or /and 1st trimester ultrasound scan).
- Singleton miscarriage
- Type of miscarriage: Incomplete or Missed miscarriage
- Surgical evacuation will be done within 2 weeks of diagnosis of miscarriage .
Key exclusion criteria (7 listed)
- Maternal age: younger than 18 years
- Induced miscarriage of pregnancy
- Septic miscarriage
- Evidence of infection
- Morbid obesity (BMI≥40kg/m2)
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 |
|---|---|---|
| Group 1: Antibiotic receiving groupAlso: Group 2 :placebo receiving groupGroup 1; receiving antibiotic prophylaxis; single dose of oral doxycycline (200 mg) tablet and metronidazole (500 mg) tablet 2 hours before the surgical evacuation Group B ;receiving placebo 2 hours before the surgical evacuation | Drug | Group (2), group(1) |
Primary outcome
Change of pelvic infection after surg ical evacuation of miscarriage with use of antibiotic prophylaxis.
Time frame: 2 weeks from surgery
White cell count >12 *10^9 cells / L by CBC
1 secondary outcome
Change in the risk of severe puerperal sepsis following the surgical procedure
Time frame: 2 weeks from surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Individual participant dataSharing planned: Undecided
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.
Marwa Mo Eid, Ass.prof. study director
Cairo University
Nihal Mo El-Demiry, lecturer principal investigator
Cairo University
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 Group 1: Antibiotic receiving group in people with Antibiotics Causing Adverse Effects in Therapeutic Use, run by Cairo 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 7 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 Mar 2022. 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 Marwa Mo Eid, Ass.professor (01001225079, marwameid2014@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pelvic infection after surg ical evacuation of miscarriage with use of antibiotic prophylaxis. (time frame: 2 weeks from surgery). 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 Mar 2022.