EndometritisNCT01945450
Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial
A study testing Antibiotic prophylaxis, Ampicillin and Gentamycin in people with Endometritis, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Background: There is scarce evidence regarding the necessity of antibiotic prophylaxis in manual revision of the uterus after labor in cases of residual placenta. Methods: a randomized control trial in which parturients for which the placenta was not separated or there is a suspected residual placenta will be divided… Read more about this study
- Who is it for?
- Ages 15 to 50 years, women only
- Conditions the study is for
- Endometritis
- What is being tested?
- Antibiotic prophylaxis, Ampicillin and Gentamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Sep 2016
- 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 15 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- suspected retained placenta
Who cannot join
- Intrapartum fever
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth
Background: There is scarce evidence regarding the necessity of antibiotic prophylaxis in manual revision of the uterus after labor in cases of residual placenta.
Methods: a randomized control trial in which parturients for which the placenta was not separated or there is a suspected residual placenta will be divided randomly to two groups: (1) Revision of uterus or Manual lysis without antibiotic prophylaxis; (2) Revision of uterus or Manual lysis with antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3. In cases of allergy to Penicillin the antibiotic regimen will be: Gentamycin 240 mg*1, Clindamycin 600 mg*3.
Outcomes: Puerperal fever, endometritis, length of hospitalization after labor, recurrent hospitalization in the first 2 weeks after discharge.
- Conditions
- Endometritis
- Being tested
- Antibiotic prophylaxis, Ampicillin, Gentamycin, Clindamycin
- Medical subject headings
- Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic prophylaxisDrug
antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3
AmpicillinDrug
GentamycinDrug
ClindamycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic prophylaxis | Active comparator | antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3 Receives: Drug: Antibiotic prophylaxis; Drug: Ampicillin; Drug: Gentamycin; Drug: Clindamycin |
| No treatment | No intervention | No antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometritis rate
Measured: 3 years
Secondary outcomes (1)
Puerperal fever
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometritisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945450
- Sponsor's protocol ID
- 0186-HMO-CTIL
- Status last verified
- Aug 2013
- First submitted
- 15 Sep 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth
- ClinicalTrials.gov ID
- NCT01945450
- Acronym / sponsor ID
- 0186-HMO-CTIL
- Conditions
- Endometritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2016 (estimated)
- First posted
- 18 Sep 2013 (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.
Background: There is scarce evidence regarding the necessity of antibiotic prophylaxis in manual revision of the uterus after labor in cases of residual placenta.
Methods: a randomized control trial in which parturients for which the placenta was not separated or there is a suspected residual placenta will be divided randomly to two groups: (1) Revision of uterus or Manual lysis without antibiotic prophylaxis; (2) Revision of uterus or Manual lysis with antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3. In cases of allergy to Penicillin the antibiotic regimen will be: Gentamycin 240 mg*1, Clindamycin 600 mg*3.
Outcomes: Puerperal fever, endometritis, length of hospitalization after labor, recurrent hospitalization in the first 2 weeks after discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic prophylaxis | Active comparator | Drug: Antibiotic prophylaxis, Drug: Ampicillin, Drug: Gentamycin, Drug: Clindamycinantibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3 |
| No treatment | No intervention | –No antibiotics |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- suspected retained placenta
Key exclusion criteria (1 listed)
- Intrapartum fever
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 |
|---|---|---|
| Antibiotic prophylaxisantibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3 | Drug | Antibiotic prophylaxis |
| Ampicillin | Drug | Antibiotic prophylaxis |
| Gentamycin | Drug | Antibiotic prophylaxis |
| Clindamycin | Drug | Antibiotic prophylaxis |
Primary outcome
Endometritis rate
Time frame: 3 years
1 secondary outcome
Puerperal fever
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic prophylaxis, Ampicillin and Gentamycin in people with Endometritis, run by Hadassah Medical Organization 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 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 27 Nov 2013. 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 Hadas Lamnerg, MD (: 00 972 2 6777572, lhadas@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometritis rate (time frame: 3 years). 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 27 Nov 2013.