ChorioamnionitisPhase 2/3NCT01633294
Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term
A Phase 2/3 study testing Ampicillin + gentamicin in people with Chorioamnionitis and Puerperal Endometritis, run by Hospital de Santa Maria, Portugal at 1 site in Portugal.
Trial summary
The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (< 12 hour) and delayed (≥ 12 hour) induction… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Chorioamnionitis, Puerperal Endometritis, Neonatal Early Onset Sepsis
- What is being tested?
- Ampicillin + gentamicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2008to Jan 2012
- Phase
- Phase 2/3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- term (≥ 37+0 weeks) singleton pregnancy
- a vertex presentation
- ruptured membranes for less than 12 hours
- negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks
Who cannot join
- active labor
- absence of GBS culture or indication for GBS antibiotic prophylaxis (such as maternal GBS colonization between 35 and 37 weeks, GBS bacteriuria, prior infant with GBS sepsis)
- contraindication to expectant management (such as fetal distress, meconium staining of the amniotic fluid or chorioamnionitis) or to vaginal delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term - a Randomized Controlled Trial
The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to antibiotic prophylaxis.
- Conditions
- Chorioamnionitis, Puerperal Endometritis, Neonatal Early Onset Sepsis, Neonatal Meningitis, Neonatal Pneumonia
- Being tested
- Ampicillin + gentamicin
- Keywords
- premature rupture of membranes, term pregnancy, chorioamnionitis, endometritis, neonatal sepsis, antibiotic prophylaxis
- Medical subject headings
- Chorioamnionitis, Neonatal Sepsis, Fetal Membranes, Premature Rupture, Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ampicillin + gentamicinDrug
ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic group | Active comparator | women submitted to antibiotic prophylaxis Receives: Drug: Ampicillin + gentamicin |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal infection rate
neonatal infection rate includes early onset sepsis, meningitis and pneumonia
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
maternal infection rate
maternal infection rate includes chorioamnionitis or puerperal endometritis
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes (1)
comparison of the infection rates between prompt and delayed induction
rate of maternal and neonatal infection between prompt (<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startOct 2008
- Primary completionJan 2011
- Study completionJan 2012
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.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Santa Maria, Portugal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filipa Faria Vaz Passos, Hospital de Santa Maria, Portugal
- Investigators
- Filipa Faria Vaz Passos, Dr, Principal investigator, Santa Maria Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633294
- Sponsor's protocol ID
- 335/08 - 28/07/08
- Status last verified
- Nov 2016
- First submitted
- 23 Jun 2012
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Passos F, Cardoso K, Coelho AM, Graca A, Clode N, Mendes da Graca L. Antibiotic prophylaxis in premature rupture of membranes at term: a randomized controlled trial. Obstet Gynecol. 2012 Nov;120(5):1045-51. doi: 10.1097/aog.0b013e31826e46bc.
PubMed 23090521
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01633294
- Acronym / sponsor ID
- 335/08 - 28/07/08
- Conditions
- Chorioamnionitis, Puerperal Endometritis, Neonatal Early Onset Sepsis, Neonatal Meningitis, Neonatal Pneumonia
- Keywords
- premature rupture of membranes, term pregnancy, chorioamnionitis, endometritis, neonatal sepsis, antibiotic prophylaxis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Hospital de Santa Maria, PortugalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Jul 2012 (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 aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to antibiotic prophylaxis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic group | Active comparator | Drug: Ampicillin + gentamicinwomen submitted to antibiotic prophylaxis |
| Control group | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- term (≥ 37+0 weeks) singleton pregnancy
- a vertex presentation
- ruptured membranes for less than 12 hours
- negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks
Key exclusion criteria (3 listed)
- active labor
- absence of GBS culture or indication for GBS antibiotic prophylaxis (such as maternal GBS colonization between 35 and 37 weeks, GBS bacteriuria, prior infant with GBS sepsis)
- contraindication to expectant management (such as fetal distress, meconium staining of the amniotic fluid or chorioamnionitis) or to vaginal 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 |
|---|---|---|
| Ampicillin + gentamicinampicillin 1 g every six hours and gentamicin 240 mg every day intravenously | Drug | Antibiotic group |
Primary outcome
neonatal infection rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
neonatal infection rate includes early onset sepsis, meningitis and pneumonia
maternal infection rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
maternal infection rate includes chorioamnionitis or puerperal endometritis
1 secondary outcome
comparison of the infection rates between prompt and delayed induction
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
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 28 Nov 2016.
- Derived from this study: PubMed 23090521Passos F, Cardoso K, Coelho AM, Graca A, Clode N, Mendes da Graca L. Antibiotic prophylaxis in premature rupture of membranes at term: a randomized controlled trial. Obstet Gynecol. 2012 Nov;120(5):1045-51. doi: 10.1097/aog.0b013e31826e46bc.
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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.
Filipa Faria Vaz Passos, Dr principal investigator
Santa Maria Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ampicillin + gentamicin in people with Chorioamnionitis and Puerperal Endometritis, run by Hospital de Santa Maria, Portugal at 1 site in Portugal.
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 4 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: finished, as of the sponsor's last update on 28 Nov 2016. 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 Portugal. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
neonatal infection rate (time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days). The study lists 2 primary outcomes in all. 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 NCT01633294, 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 28 Nov 2016.