Outpatient Mechanical Cervix PrimingNCT02842879
Outpatient Foley Cervix Priming
A study testing Outpatient Foley cervix priming in people with Outpatient Mechanical Cervix Priming, run by Hospital de Santa Maria, Portugal.
Trial summary
The aim was to conduct a non-blinded prospective randomized study at a tertiary hospital. Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop score < 6, gestational age > 41 weeks or medical indication for induction of labor. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Outpatient Mechanical Cervix Priming
- What is being tested?
- Outpatient Foley cervix priming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2015
- 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 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- women with a single fetus in cephalic presentation
- Bishop score < 6
- Gestational age > 41 weeks or medical indication for induction of labor submitted to cervix priming with Foley catheter
Who cannot join
- women with a fetus in noncephalic presentation
- an indication for elective cesarean delivery
- spontaneous labor
- hydramnios (amniotic fluid index ≥ 25)
- nonreassuring cardiotocogram
- multiple pregnancy
Show all 12Show fewer
- rupture of membranes
- active vaginal bleeding
- indication for prophylaxis of Streptococcus group B infection
- HIV infection
- cervical injury
- previous cesarean section with recurrent indication
About this study
Official title: Outpatient Versus Inpatient Cervix Priming With Foley Catheter
The aim was to conduct a non-blinded prospective randomized study at a tertiary hospital. Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop score < 6, gestational age > 41 weeks or medical indication for induction of labor.
Patients will be randomized to outpatient or inpatient cervix priming with Foley catheter.
The primary outcome will be to compare the variation of Bishop score (difference between Bishop score before and after application of Foley catheter) between outpatient and inpatient groups. Secondary comparisons include: mode of delivery, Foley catheter application-to-delivery time, inpatient time, sequential use of prostaglandins, infection and maternal pain.
- Conditions
- Outpatient Mechanical Cervix Priming
- Being tested
- Outpatient Foley cervix priming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient Foley cervix primingOther
Outpatient setting for cervix priming with Foley catheter
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Foley cervix priming | Experimental | Patients randomized to outpatient cervix priming will have the insertion of the catheter in the same conditions defined by the Department protocol for inpatient cervix priming. They will be discharged after a reassuring cardiotocogram following the introduction of the Foley catheter. When discharged, the patients will be instructed to apply manual traction to the catheter every 6 hours and they will be given a written document with all the information that should bring them back to hospital. Receives: Other: Outpatient Foley cervix priming |
| Inpatient Foley cervix priming | No intervention | The introduction of a deflated catheter (Foley catheter nº 16F) through the outer cervix orifice is preceded by iodine disinfection of the cervix. The intracervical catheter is distended with 40mL of a saline solution. The end of the catheter is taped to the medial portion of the thigh and manual traction is applied to the catheter every 6 hours. If it is not spontaneously extruded it is removed after 24h. Cervix priming occurs in an inpatient setting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of bishop score (difference between bishop score before and after application of foley catheter)
Measured: up to 24 months
Secondary outcomes (3)
mode of delivery
Measured: up to 24 months
induction-to-delivery time
Measured: up to 24 months
maternal pain evaluated by visual analog scale for pain
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Outpatient Mechanical Cervix PrimingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Santa Maria, Portugal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catarina Policiano, Hospital de Santa Maria, Portugal
- Investigators
- Catarina Policiano, MD, Principal investigator, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842879
- Sponsor's protocol ID
- SantaMariaPortugal
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2016
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.
PubMed 32852803Policiano C, Pimenta M, Martins D, Clode N. Outpatient versus inpatient cervix priming with Foley catheter: A randomized trial. Eur J Obstet Gynecol Reprod Biol. 2017 Mar;210:1-6. doi: 10.1016/j.ejogrb.2016.11.026. Epub 2016 Nov 27.
PubMed 27923165
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Versus Inpatient Cervix Priming With Foley Catheter
- ClinicalTrials.gov ID
- NCT02842879
- Acronym / sponsor ID
- SantaMariaPortugal
- Conditions
- Outpatient Mechanical Cervix Priming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital de Santa Maria, PortugalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Jul 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 aim was to conduct a non-blinded prospective randomized study at a tertiary hospital. Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop score < 6, gestational age > 41 weeks or medical indication for induction of labor.
Patients will be randomized to outpatient or inpatient cervix priming with Foley catheter.
The primary outcome will be to compare the variation of Bishop score (difference between Bishop score before and after application of Foley catheter) between outpatient and inpatient groups. Secondary comparisons include: mode of delivery, Foley catheter application-to-delivery time, inpatient time, sequential use of prostaglandins, infection and maternal pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient Foley cervix priming | Experimental | Other: Outpatient Foley cervix primingPatients randomized to outpatient cervix priming will have the insertion of the catheter in the same conditions defined by the Department protocol for inpatient cervix priming. They will be discharged after a reassuring cardiotocogram following the introduction of the Foley catheter. When discharged, the patients will be instructed to apply manual traction to the catheter every 6 hours and they will be given a written document with all the information that should bring them back to hospital. |
| Inpatient Foley cervix priming | No intervention | –The introduction of a deflated catheter (Foley catheter nº 16F) through the outer cervix orifice is preceded by iodine disinfection of the cervix. The intracervical catheter is distended with 40mL of a saline solution. The end of the catheter is taped to the medial portion of the thigh and manual traction is applied to the catheter every 6 hours. If it is not spontaneously extruded it is removed after 24h. Cervix priming occurs in an inpatient setting. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- women with a single fetus in cephalic presentation
- Bishop score < 6
- Gestational age > 41 weeks or medical indication for induction of labor submitted to cervix priming with Foley catheter
Key exclusion criteria (12 listed)
- women with a fetus in noncephalic presentation
- an indication for elective cesarean delivery
- spontaneous labor
- hydramnios (amniotic fluid index ≥ 25)
- nonreassuring cardiotocogram
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 |
|---|---|---|
| Outpatient Foley cervix primingOutpatient setting for cervix priming with Foley catheter | Other | Outpatient Foley cervix priming |
Primary outcome
variation of bishop score (difference between bishop score before and after application of foley catheter)
Time frame: up to 24 months
3 secondary outcomes
mode of delivery
Time frame: up to 24 months
induction-to-delivery time
Time frame: up to 24 months
maternal pain evaluated by visual analog scale for pain
Time frame: up to 24 months
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 25 Jul 2016.
- Derived from this study: PubMed 32852803Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.
- Derived from this study: PubMed 27923165Policiano C, Pimenta M, Martins D, Clode N. Outpatient versus inpatient cervix priming with Foley catheter: A randomized trial. Eur J Obstet Gynecol Reprod Biol. 2017 Mar;210:1-6. doi: 10.1016/j.ejogrb.2016.11.026. Epub 2016 Nov 27.
- Individual participant dataSharing planned: Yes
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.
Catarina Policiano, MD principal investigator
Hospital de Santa Maria, Centro Hospitalar Lisboa Norte
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient Foley cervix priming in people with Outpatient Mechanical Cervix Priming, run by Hospital de Santa Maria, 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 3 inclusion and 12 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 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
variation of bishop score (difference between bishop score before and after application of foley catheter) (time frame: up to 24 months). 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 NCT02842879, which also lists 2 linked publications.
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 25 Jul 2016.