ChorioamnionitisNCT00185991
Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis
A study testing gentamicin in people with Chorioamnionitis, run by Stanford University at 1 site in United States.
Trial summary
To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chorioamnionitis
- What is being tested?
- gentamicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Feb 2010
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of chorioamnionitis
Who cannot join
- maternal renal disease, intrauterine fetal death, allergy to gentamicin
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis.
- Conditions
- Chorioamnionitis
- Being tested
- gentamicin
- Medical subject headings
- Chorioamnionitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gentamicinDrug
Daily gentamicin (5 mg/kg intravenously, then placebo doses IV after 8 and 16 hours).
Eight hour gentamicin (2 mg/kg intravenously, then 1.5 mg/kg IV after 8 and 16 hours).
| Study group | Role | What they receive |
|---|---|---|
| Once daily Gentamicin | Active comparator | Not described Receives: Drug: gentamicin |
| Every eight hour Gentamicin | Active comparator | Not described Receives: Drug: gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Afebrile at 24 hours and no endometritis
Measured: 24 hours after delivery
Secondary outcomes (1)
Neonatal outcomes
Measured: Time of delivery to time of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionOct 2006
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChorioamnionitisStudies of the same condition, open and under way.
- More trials run by Stanford 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Investigators
- Yasser Yehia El-Sayed, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185991
- Sponsor's protocol ID
- 80104
- Status last verified
- Jun 2011
- First submitted
- 12 Sep 2005
- Last updated
- 15 Jun 2011
- Results posted
- No
Publications
Lyell DJ, Pullen K, Fuh K, Zamah AM, Caughey AB, Benitz W, El-Sayed YY. Daily compared with 8-hour gentamicin for the treatment of intrapartum chorioamnionitis: a randomized controlled trial. Obstet Gynecol. 2010 Feb;115(2 Pt 1):344-349. doi: 10.1097/AOG.0b013e3181cb5c0e.
PubMed 20093909
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis
- ClinicalTrials.gov ID
- NCT00185991
- Acronym / sponsor ID
- 80104
- Conditions
- Chorioamnionitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 Sep 2005 (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.
To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once daily Gentamicin | Active comparator | Drug: gentamicin |
| Every eight hour Gentamicin | Active comparator | Drug: gentamicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of chorioamnionitis
Key exclusion criteria (1 listed)
- maternal renal disease, intrauterine fetal death, allergy to gentamicin
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 |
|---|---|---|
| gentamicinDaily gentamicin (5 mg/kg intravenously, then placebo doses IV after 8 and 16 hours). Eight hour gentamicin (2 mg/kg intravenously, then 1.5 mg/kg IV after 8 and 16 hours). | Drug | Every eight hour Gentamicin, Once daily Gentamicin |
Primary outcome
Afebrile at 24 hours and no endometritis
Time frame: 24 hours after delivery
1 secondary outcome
Neonatal outcomes
Time frame: Time of delivery to time of discharge
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 15 Jun 2011.
- Results publication: PubMed 20093909Lyell DJ, Pullen K, Fuh K, Zamah AM, Caughey AB, Benitz W, El-Sayed YY. Daily compared with 8-hour gentamicin for the treatment of intrapartum chorioamnionitis: a randomized controlled trial. Obstet Gynecol. 2010 Feb;115(2 Pt 1):344-349. doi: 10.1097/AOG.0b013e3181cb5c0e.
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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.
Yasser Yehia El-Sayed principal investigator
Stanford 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 gentamicin in people with Chorioamnionitis, run by Stanford University at 1 site in United States.
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: finished, as of the sponsor's last update on 15 Jun 2011. 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 United States. 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?
Afebrile at 24 hours and no endometritis (time frame: 24 hours after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00185991, which also lists 1 linked publication.
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 15 Jun 2011.