Maternal Infection During Pregnancy (Diagnosis)NCT02985086
Immediate Versus Delayed Induction in Term-PROM Using or Not Antibiotic Prophylaxis
A study testing Cefoxitin and oxytocin/misoprostol in people with Maternal Infection During Pregnancy (Diagnosis) and Neonatal Infection, run by Hospital de Santa Maria, Portugal at 2 sites in Portugal.
Trial summary
The primary aim of this study is to determine if antibiotics combined with immediate induction can significantly reduce the rate of maternal and neonatal infection compared with immediate induction alone in women presenting with PROM later than the 37+0 weeks of gestation. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Infection During Pregnancy (Diagnosis), Neonatal Infection
- What is being tested?
- Cefoxitin and oxytocin/misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- 2 sitesPortugal
- Study dates
- Jul 2013to Jul 2018
- 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 Any age
- Women only
- Healthy volunteers accepted
- 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 and a 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, contraindication to expectant management or to vaginal delivery
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites, 2 recruiting
- Recruiting
Hospital Garcia de Orta, EPE
Almada
- Recruiting
Hospital de Santa Maria, CHLN, EPE
Lisbon
About this study
Official title: The Role of Antibiotic Prophylaxis in Immediate Versus Delayed Induction in Term-PROM - a Randomized Controlled Trial
The primary aim of this study is to determine if antibiotics combined with immediate induction can significantly reduce the rate of maternal and neonatal infection compared with immediate induction alone in women presenting with PROM later than the 37+0 weeks of gestation. The secondary aim is to compare the rates of infection between immediate and delayed induction in women submitted to antibiotic prophylaxis.
Read the detailed description
In a randomized controlled non-blind trial, low-risk women with singleton term pregnancies and a negative Group B Streptococcus culture presenting with PROM are randomly assigned to group A (immediate induction with antibiotic prophylaxis), group B (immediate induction without antibiotic prophylaxis) or group C (delayed induction with antibiotic prophylaxis).
- Being tested
- Cefoxitin, oxytocin/misoprostol
- Keywords
- term premature rupture of membranes, antibiotic prophylaxis, chorioamnionitis, endometritis, neonatal infection
- Medical subject headings
- Disease, Fetal Membranes, Premature Rupture, Chorioamnionitis, Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefoxitinDrug
oxytocin/misoprostolDrug
| Study group | Role | What they receive |
|---|---|---|
| Immediate induction with antibiotic prophylaxis | Active comparator | Immediate induction with antibiotic prophylaxis Receives: Drug: Cefoxitin; Drug: oxytocin/misoprostol |
| Immediate induction without antibiotic prophylaxis | Active comparator | Immediate induction without antibiotic prophylaxis Receives: Drug: oxytocin/misoprostol |
| Delayed induction with antibiotic prophylaxis | Active comparator | Delayed induction (>= 12 hours after PROM) with antibiotic prophylaxis Receives: Drug: Cefoxitin; Drug: oxytocin/misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal and neonatal infection rate
Measured: intrapartum and immediate postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startJul 2013
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Infection During Pregnancy (Diagnosis)Studies 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
- Masking
- None (open label)
- Enrolment
- 568 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985086
- Sponsor's protocol ID
- SantaMariaGarciadeOrtaPortugal
- Status last verified
- Dec 2016
- First submitted
- 5 Dec 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Antibiotic Prophylaxis in Immediate Versus Delayed Induction in Term-PROM - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02985086
- Acronym / sponsor ID
- SantaMariaGarciadeOrtaPortugal
- Keywords
- term premature rupture of membranes, antibiotic prophylaxis, chorioamnionitis, endometritis, neonatal infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 568 participants (estimated)
- Lead sponsor
- Hospital de Santa Maria, PortugalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 7 Dec 2016 (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 primary aim of this study is to determine if antibiotics combined with immediate induction can significantly reduce the rate of maternal and neonatal infection compared with immediate induction alone in women presenting with PROM later than the 37+0 weeks of gestation. The secondary aim is to compare the rates of infection between immediate and delayed induction in women submitted to antibiotic prophylaxis.
Detailed description
In a randomized controlled non-blind trial, low-risk women with singleton term pregnancies and a negative Group B Streptococcus culture presenting with PROM are randomly assigned to group A (immediate induction with antibiotic prophylaxis), group B (immediate induction without antibiotic prophylaxis) or group C (delayed induction with antibiotic prophylaxis).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate induction with antibiotic prophylaxis | Active comparator | Drug: Cefoxitin, Drug: oxytocin/misoprostolImmediate induction with antibiotic prophylaxis |
| Immediate induction without antibiotic prophylaxis | Active comparator | Drug: oxytocin/misoprostolImmediate induction without antibiotic prophylaxis |
| Delayed induction with antibiotic prophylaxis | Active comparator | Drug: Cefoxitin, Drug: oxytocin/misoprostolDelayed induction (>= 12 hours after PROM) with antibiotic prophylaxis |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- term (≥ 37+0 weeks) singleton pregnancy, a vertex presentation, ruptured membranes for less than 12 hours and a negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks.
Key exclusion criteria (1 listed)
- active labor, absence of GBS culture or indication for GBS antibiotic prophylaxis, contraindication to expectant management 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 |
|---|---|---|
| Cefoxitin | Drug | Delayed induction with antibiotic prophylaxis, Immediate induction with antibiotic prophylaxis |
| oxytocin/misoprostol | Drug | Delayed induction with antibiotic prophylaxis, Immediate induction with antibiotic prophylaxis, Immediate induction without antibiotic prophylaxis |
Primary outcome
Maternal and neonatal infection rate
Time frame: intrapartum and immediate postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefoxitin and oxytocin/misoprostol in people with Maternal Infection During Pregnancy (Diagnosis) and Neonatal Infection, run by Hospital de Santa Maria, Portugal at 2 sites 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 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 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Filipa FV Passos, MD (00351966634530, filipafariavazpassos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal and neonatal infection rate (time frame: intrapartum and immediate postpartum). 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 13 Dec 2016.