Prolonged PregnancyNCT02793609
Outpatient Versus Inpatient Balloon Catheter Induction of Labor
A study testing Intervention is to let patient to go home. and Intervention is to observe women in the ward. in people with Prolonged Pregnancy, run by Turku University Hospital at 1 site in Finland.
Trial summary
Randomized trial comparing double balloon catheter for induction of labor between in- and outpatient groups.Investigators assess feasibility, clinical effectiveness and patient acceptability of outpatient versus inpatient catheter for induction of labor. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolonged Pregnancy
- What is being tested?
- Intervention is to let patient to go home. and Intervention is to observe women in the ward.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jun 2016to 30 Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- uncomplicated pregnancy
- singleton pregnancy
- pregnancy weeks between >37 and <41+5
- the patient is living in 1/2 hour away from hospital
Who cannot join
- patient has any disease or medication
- multiple pregnancy
- pregnancy week > 41+5
- preterm rupture of membranes
- patient living more than 1/2 hour away from hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outpatient Versus Inpatient Double Balloon Catheter for Induction of Labor: a Randomised Trial
Randomized trial comparing double balloon catheter for induction of labor between in- and outpatient groups.Investigators assess feasibility, clinical effectiveness and patient acceptability of outpatient versus inpatient catheter for induction of labor.
Read the detailed description
The objective of this study is to describe labor outcomes in women with double balloon induction catheter of labor. Participants included are women with uncomplicated singleton pregnancy of ≥37- ≤41+5 weeks of gestation. Patients are randomized to two groups: one hundred are randomized to the inpatient and one hundred to the outpatient group.
The main outcome measure is the pain evaluated by VAS at one, five, nine and 13 hours after the placement of double balloon induction catheter. The total hospital stay and induction to delivery interval time is measured. Also the mode of birth as well as maternal and neonatal morbidity and patient satisfaction are recorded.
- Conditions
- Prolonged Pregnancy
- Being tested
- Intervention is to let patient to go home., Intervention is to observe women in the ward.
- Keywords
- induction of labor, double balloon catheter, mechanical ripening
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention is to let patient to go home.Other
Intervention is to let patient to go home.
Intervention is to observe women in the ward.Other
Intervention is to observe women in the ward.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient group | Other | After insertion of double balloon induction catheter of labor, women are discharged overnight to home. Intervention is to let patient to go home. Receives: Other: Intervention is to let patient to go home. |
| Inpatient group | Other | After insertion of double balloon induction catheter of labor, women are observed in the prenatal ward. Intervention is to observe women in the ward. Receives: Other: Intervention is to observe women in the ward. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain measured by visual analogy scale(VAS) after double balloon catheter
Visual analogy score assessed by patient. Minimum 1mm to maximum 100 mm.
Measured: During the induction of the labor and postpartum period in the hospital.
Secondary outcomes (3)
The maternal morbidity
number of mothers having any kind of infection
Measured: during the induction of the labor and postpartum period in the hospital
The total hospital stay in both groups
length in days
Measured: maximum 14 days
neonatal morbidity
number of babies having any kind of infection
Measured: during the induction of the labor and postpartum period in the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start1 Jun 2016
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prolonged PregnancyStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Sponsor
- Investigators
- Kirsi M Rinne, PhD, Principal investigator, Turku University HospitalPäivi ML Polo, PhD, Study director, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793609
- Sponsor's protocol ID
- T169/2016
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2016
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Letter to patients.
Publications
Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
PubMed 11704164Prager M, Eneroth-Grimfors E, Edlund M, Marions L. A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction. BJOG. 2008 Oct;115(11):1443-50. doi: 10.1111/j.1471-0528.2008.01843.x. Epub 2008 Aug 19.
PubMed 18715244Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.
PubMed 23356673Alfirevic 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 32852803
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Versus Inpatient Double Balloon Catheter for Induction of Labor: a Randomised Trial
- ClinicalTrials.gov ID
- NCT02793609
- Acronym / sponsor ID
- T169/2016
- Conditions
- Prolonged Pregnancy
- Keywords
- induction of labor, double balloon catheter, mechanical ripening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 8 Jun 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.
Randomized trial comparing double balloon catheter for induction of labor between in- and outpatient groups.Investigators assess feasibility, clinical effectiveness and patient acceptability of outpatient versus inpatient catheter for induction of labor.
Detailed description
The objective of this study is to describe labor outcomes in women with double balloon induction catheter of labor. Participants included are women with uncomplicated singleton pregnancy of ≥37- ≤41+5 weeks of gestation. Patients are randomized to two groups: one hundred are randomized to the inpatient and one hundred to the outpatient group.
The main outcome measure is the pain evaluated by VAS at one, five, nine and 13 hours after the placement of double balloon induction catheter. The total hospital stay and induction to delivery interval time is measured. Also the mode of birth as well as maternal and neonatal morbidity and patient satisfaction are recorded.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient group | Other | Other: Intervention is to let patient to go home.After insertion of double balloon induction catheter of labor, women are discharged overnight to home. Intervention is to let patient to go home. |
| Inpatient group | Other | Other: Intervention is to observe women in the ward.After insertion of double balloon induction catheter of labor, women are observed in the prenatal ward. Intervention is to observe women in the ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- uncomplicated pregnancy
- singleton pregnancy
- pregnancy weeks between >37 and <41+5
- the patient is living in 1/2 hour away from hospital
Key exclusion criteria (5 listed)
- patient has any disease or medication
- multiple pregnancy
- pregnancy week > 41+5
- preterm rupture of membranes
- patient living more than 1/2 hour away from hospital
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 |
|---|---|---|
| Intervention is to let patient to go home.Intervention is to let patient to go home. | Other | Outpatient group |
| Intervention is to observe women in the ward.Intervention is to observe women in the ward. | Other | Inpatient group |
Primary outcome
The pain measured by visual analogy scale(VAS) after double balloon catheter
Time frame: During the induction of the labor and postpartum period in the hospital.
Visual analogy score assessed by patient. Minimum 1mm to maximum 100 mm.
3 secondary outcomes
The maternal morbidity
Time frame: during the induction of the labor and postpartum period in the hospital
The total hospital stay in both groups
Time frame: maximum 14 days
neonatal morbidity
Time frame: during the induction of the labor and postpartum period in the hospital
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 9 Jun 2020.
- Background: PubMed 11704164Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.
- Background: PubMed 18715244Prager M, Eneroth-Grimfors E, Edlund M, Marions L. A randomised controlled trial of intravaginal dinoprostone, intravaginal misoprostol and transcervical balloon catheter for labour induction. BJOG. 2008 Oct;115(11):1443-50. doi: 10.1111/j.1471-0528.2008.01843.x. Epub 2008 Aug 19.
- Results publication: PubMed 23356673Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.
- 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.
- Individual participant dataSharing planned: Undecided. Letter to patients.
Related trials for Prolonged Pregnancy
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruitingPhase 2
CAffeine Use in Prolonged Oxygen Use in meConium aspIration Syndrome in Neonatal Outcomes (CAPUCINO)
Meconium Aspiration Syndrome
RecruitingPhase 2
Is Prolonged Systemic Immunotherapy Necessary After Achieving Tumor-free Status in Patients With Extensive Transurethrally Unresectable Very-high-risk NMIBC?
Bladder (Urothelial, Transitional Cell) Cancer, Non Muscle Invasive Bladder Cancer
Recruiting
Maternal Maneuvers During Prolonged Labor
Labor Stage, First, Prolonged Labor
RecruitingObservational study
uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
Urothelial Carcinoma, Urothelial Carcinoma Recurrent
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.
Kirsi M Rinne, PhD principal investigator
Turku University Hospital
Päivi ML Polo, PhD study director
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention is to let patient to go home. and Intervention is to observe women in the ward. in people with Prolonged Pregnancy, run by Turku University Hospital at 1 site in Finland.
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 5 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 9 Jun 2020. 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 Finland. 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?
The pain measured by visual analogy scale(VAS) after double balloon catheter (time frame: During the induction of the labor and postpartum period in the hospital.). 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 NCT02793609, which also lists 4 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 9 Jun 2020.