Puerperal InfectionPATPETNCT04763486
Prophylactic Antibiotic After Perineal Tear
A study testing Cefazolin (Cefamezin) in people with Puerperal Infection, run by Meir Medical Center at 1 site in Israel.
Trial summary
Current World Health Organization guidelines recommend routine antibiotic prophylaxis for women with perineal tear 3rd and 4th degree but not for 2nd degree because of insufficient evidence of effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Puerperal Infection
- What is being tested?
- Cefazolin (Cefamezin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2021to 1 Mar 2023
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-45
- perineal tear 2nd and 1st degree( episiotomy)
Who cannot join
- 3rd and 4 th degree perineal tear
- antibiotic indication during delivery
- cesarian section delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Antibiotic Treatment for Perineal Tear After Delivery: a Randomized Controlled Trial
Current World Health Organization guidelines recommend routine antibiotic prophylaxis for women with perineal tear 3rd and 4th degree but not for 2nd degree because of insufficient evidence of effectiveness. The investigators aimed to investigate whether antibiotic prophylaxis prevented maternal infection after the first and second perineal tear after vaginal birth.
Read the detailed description
The PATPET trial is a randomized, controlled trial done at tertiary hospital obstetric units in Israel. Women who had first and second-degree tear (or after episiotomy) after delivery at 37 weeks or greater gestation, with no indication for ongoing prescription of antibiotics in the post-partum period and no contraindications to prophylactic Cefamezin (cefazolin), were randomly assigned (1:1) to receive a single intravenous dose of prophylactic antibiotic or not.
- Conditions
- Puerperal Infection
- Being tested
- Cefazolin (Cefamezin)
- Medical subject headings
- Puerperal Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefazolin (Cefamezin)Drug
Cefamezin 2 gr within 6 hour of delivery
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic antibiotic treatment | Experimental | Will be given Cefamezin antibiotic within 6 hours of delivery Receives: Drug: Cefazolin (Cefamezin) |
| No intervention | No intervention | Will not get antibiotic prophylactics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a fever after delivery
Maternal fever above 38 C (Celsius)
Measured: 6 weeks of delivery
Secondary outcomes (1)
Way of delivery
Type of delivery- vacuum-assisted delivery vs. vaginally
Measured: 6 weeks of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Puerperal InfectionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parturition
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Daykan, Meir Medical Center
- Investigators
- Gil Shechter, Dr, Principal investigator, Meir Medical Center , Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763486
- Sponsor's protocol ID
- 0189-19-MMC
- Acronym
- PATPET
- Status last verified
- Feb 2021
- First submitted
- 29 Jul 2019
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotic Treatment for Perineal Tear After Delivery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04763486
- Acronym / sponsor ID
- PATPET / 0189-19-MMC
- Conditions
- Puerperal Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 21 Feb 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.
Current World Health Organization guidelines recommend routine antibiotic prophylaxis for women with perineal tear 3rd and 4th degree but not for 2nd degree because of insufficient evidence of effectiveness. The investigators aimed to investigate whether antibiotic prophylaxis prevented maternal infection after the first and second perineal tear after vaginal birth.
Detailed description
The PATPET trial is a randomized, controlled trial done at tertiary hospital obstetric units in Israel. Women who had first and second-degree tear (or after episiotomy) after delivery at 37 weeks or greater gestation, with no indication for ongoing prescription of antibiotics in the post-partum period and no contraindications to prophylactic Cefamezin (cefazolin), were randomly assigned (1:1) to receive a single intravenous dose of prophylactic antibiotic or not.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- parturition
| Arm | Type | Receives |
|---|---|---|
| Prophylactic antibiotic treatment | Experimental | Drug: Cefazolin (Cefamezin)Will be given Cefamezin antibiotic within 6 hours of delivery |
| No intervention | No intervention | –Will not get antibiotic prophylactics |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 18-45
- perineal tear 2nd and 1st degree( episiotomy)
Key exclusion criteria (3 listed)
- 3rd and 4 th degree perineal tear
- antibiotic indication during delivery
- cesarian section delivery
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 |
|---|---|---|
| Cefazolin (Cefamezin)Cefamezin 2 gr within 6 hour of delivery | Drug | Prophylactic antibiotic treatment |
Primary outcome
Number of participants with a fever after delivery
Time frame: 6 weeks of delivery
Maternal fever above 38 C (Celsius)
1 secondary outcome
Way of delivery
Time frame: 6 weeks of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: Undecided. Yes
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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.
Gil Shechter, Dr principal investigator
Meir Medical Center , Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefazolin (Cefamezin) in people with Puerperal Infection, run by Meir Medical Center at 1 site in Israel.
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 3 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 23 Feb 2021. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yair Daykan, Dr (+972542198231, yair.dykan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a fever after delivery (time frame: 6 weeks of delivery). 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 23 Feb 2021.