Perineal Wound InfectionPhase 4NCT02131818
Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term
A Phase 4 study testing Amoxicillin in people with Perineal Wound Infection, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine amoxicillin is effective in the prevention of wound infection in normal labor. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Perineal Wound Infection
- What is being tested?
- Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteThailand
- Study dates
- May 2014to Nov 2015
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Term pregnancy
- Normal labor
Who cannot join
- Penicillin allergy
- Previous history antibiotic using within 2 weeks
- Patients cannot take oral medication
- Patients have underlying disease eg. diabetes mellitus, hypertension, HIV infection
- Premature rupture of membranes
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hoapital Mahidol University
Bangkok, 10700
About this study
The purpose of this study is to determine amoxicillin is effective in the prevention of wound infection in normal labor.
Read the detailed description
When the pregnant women is admitted due to first stage of labor , the investigator will inform the patients. If the patients give consent, the patient's data will be collect in case record form. the patients will be swab at posterior fornix and around anus to collect specimen and send to microbiology lab before per vaginal examination. After the patients finish in labor, perineal wound will be swab to collect specimen and send to microbiology lab. Then the patients are randomized in two group, the first one will receive amoxicillin and the second one will receive placebo. During admission the patients will be exam by investigator every day. After the patients are discharge, the follow up will be appoint on 6 weeks later. The infant will be swab at rectum to collect specimen and send to microbiology lab when the patient's discharge day. Every specimen will be culture for bacteria and perform antimicrobial susceptibility test for amoxicillin.
- Conditions
- Perineal Wound Infection
- Being tested
- Amoxicillin, Placebo
- Keywords
- amoxicillin, postpartum infections, puerperal infection
- Medical subject headings
- Puerperal Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Also called Drug A, Drug B
The patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days
PlaceboDrug
Also called Drug A, Drug B
The patient will be received placebo 2 capsules orally bid pc for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin | Experimental | The patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days Receives: Drug: Amoxicillin |
| Placebo | Placebo comparator | The patient will be received placebo 2 capsules orally bid pc for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of perineal wound infection
Follow up perineal wound every day during admission and follow up 6 weeks after discharge
Measured: within 6 weeks after normal labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: The enrollment process is too difficult to complete
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal Wound InfectionStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vitaya Titapant, MD, Principal investigator, Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131818
- Sponsor's protocol ID
- SI-OBG-CEU-01-2014
- Status last verified
- Dec 2015
- First submitted
- 28 Apr 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necessity of Antibiotics for Prevention of Delivery-associated Infections After Spontaneous Vaginal Delivery at Term
- ClinicalTrials.gov ID
- NCT02131818
- Acronym / sponsor ID
- SI-OBG-CEU-01-2014
- Conditions
- Perineal Wound Infection
- Keywords
- amoxicillin, postpartum infections, puerperal infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The enrollment process is too difficult to complete
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 6 May 2014 (estimated)
- 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.
The purpose of this study is to determine amoxicillin is effective in the prevention of wound infection in normal labor.
Detailed description
When the pregnant women is admitted due to first stage of labor , the investigator will inform the patients. If the patients give consent, the patient's data will be collect in case record form. the patients will be swab at posterior fornix and around anus to collect specimen and send to microbiology lab before per vaginal examination. After the patients finish in labor, perineal wound will be swab to collect specimen and send to microbiology lab. Then the patients are randomized in two group, the first one will receive amoxicillin and the second one will receive placebo. During admission the patients will be exam by investigator every day. After the patients are discharge, the follow up will be appoint on 6 weeks later. The infant will be swab at rectum to collect specimen and send to microbiology lab when the patient's discharge day. Every specimen will be culture for bacteria and perform antimicrobial susceptibility test for amoxicillin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin | Experimental | Drug: AmoxicillinThe patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboThe patient will be received placebo 2 capsules orally bid pc for 5 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Term pregnancy
- Normal labor
Key exclusion criteria (5 listed)
- Penicillin allergy
- Previous history antibiotic using within 2 weeks
- Patients cannot take oral medication
- Patients have underlying disease eg. diabetes mellitus, hypertension, HIV infection
- Premature rupture of membranes
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 |
|---|---|---|
| AmoxicillinAlso: Drug A, Drug BThe patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days | Drug | Amoxicillin |
| PlaceboAlso: Drug A, Drug BThe patient will be received placebo 2 capsules orally bid pc for 5 days | Drug | Placebo |
Primary outcome
Incidence of perineal wound infection
Time frame: within 6 weeks after normal labor
Follow up perineal wound every day during admission and follow up 6 weeks after discharge
Results and safety
The study was stopped early (reason given: The enrollment process is too difficult to complete). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
Related trials for Perineal Wound Infection
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Vitaya Titapant, MD principal investigator
Department of Obstetrics & Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
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 Amoxicillin in people with Perineal Wound Infection, run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 3 Dec 2015. 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 Thailand. 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?
The study was stopped early (reason given: The enrollment process is too difficult to complete). Results are not available in the source record.
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?
Incidence of perineal wound infection (time frame: within 6 weeks after normal labor). 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 3 Dec 2015.