Prolonged PregnancyNCT03380897
Sleep and Depression in Induction of Labour
A study testing Intervention for outpatient group was to go home and Intervention for inpatient group was to stay at ward in people with Prolonged Pregnancy and Sleep Disturbance, run by Turku University Hospital at 1 site in Finland.
Trial summary
Randomised trial comparing double balloon catheter for induction of labor between inpatient and outpatient groups. The investigators assess how sleep disturbances and depression of the mother affect to the pain during balloon catheter induction of labour. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolonged Pregnancy, Sleep Disturbance, Depression
- What is being tested?
- Intervention for outpatient group was to go home and Intervention for inpatient group was to stay at ward
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteFinland
- Study dates
- 7 Jun 2017to 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- uncomplicated pregnancy
- singleton pregnancy
- pregnancy weeks ≥ 37 - ≤ 41+5
- the patient is living in1/2 hour away from hospital
Who cannot join
- patient has a disease that is effecting to the pregnancy e.g. pre-eclampsia, gestational hepatosis
- the patient has medical treatment of diabetes
- baby is not growing normally
- multiple pregnancy
- preterm rupture of membranes
- earlier caesarean section
- the patient is living more than 1/2 hour away from hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Disturbances and Depression of the Mother Affect to the Pain During Balloon Catheter Induction of Labour
Randomised trial comparing double balloon catheter for induction of labor between inpatient and outpatient groups. The investigators assess how sleep disturbances and depression of the mother affect to the pain during balloon catheter induction of labour.
Read the detailed description
Participants included to this randomised study are women with uncomplicated singleton pregnancy with ≥ 37- ≤ 41+5 weeks of gestation. Participants are randomised to two groups: one hundred are randomised 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 investigators assess also the effect of the sleep disturbance and depression of the mother to the pain during balloon catheter induction of the labour.
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, Sleep Disturbance, Depression
- Being tested
- Intervention for outpatient group was to go home, Intervention for inpatient group was to stay at ward
- Keywords
- induction of labor, double balloon catheter, mechanical ripening
- Medical subject headings
- Pregnancy, Prolonged, Parasomnias, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention for outpatient group was to go homeOther
Also called Intervention was to assess the pain by visual analogy scale.
Intervention for outpatient group was to go home and assess the the pain
Intervention for inpatient group was to stay at wardOther
Also called Intervention was to assess the pain by visual analogy scale.
Intervention for inpatient group was to stay at ward and assess the pain
| Study group | Role | What they receive |
|---|---|---|
| Outpatient group | Active comparator | After insertion of induction catheter for labor, women of the outpatient group can go home and assess their pain with visual analogy scale at home. The intervention is to go home.
Intervention for outpatient group was to go home. Receives: Other: Intervention for outpatient group was to go home |
| Inpatient group | Placebo comparator | After insertion of induction catheter for labor, women of the inpatient group assess their pain with visual analogy scale in the ward. The intervention is to stay at ward.
Intervention for inpatient group was to stay at ward. Receives: Other: Intervention for inpatient group was to stay at ward |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain measured by VAS
The pain measured by VAS after double balloon catheter insertion.
Measured: one to 14 days after induction of the labor
Secondary outcomes (4)
The affect of the sleep disturbances of the mother to the pain assessed by VAS
The affect of the sleep disturbances to the pain assessed by VAS
Measured: one to 14 days after induction of the labor
The effect of depression of the mother to the pain assessed by VAS
The effect of depression of the mother to the pain assessed by VAS
Measured: one to 14 days after induction of the labor
The total hospital stay in both groups
The total hospital stay in both groups
Measured: one to 14 days after induction of the labor
The maternal and neonatal morbidity after balloon catheter induction
The maternal and neonatal morbidity after balloon catheter induction
Measured: one to 14 days after induction of the labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start7 Jun 2017
- 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 (3)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
- Model description
- Factorial assignment
- 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
- Principal investigator, Kirsi Rinne, Turku University Hospital
- 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
- NCT03380897
- Sponsor's protocol ID
- T146/2017
- Status last verified
- Jun 2020
- First submitted
- 30 May 2017
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Letter to patients
Publications
Henry 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 23356673Sciscione 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 18715244
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbances and Depression of the Mother Affect to the Pain During Balloon Catheter Induction of Labour
- ClinicalTrials.gov ID
- NCT03380897
- Acronym / sponsor ID
- T146/2017
- Conditions
- Prolonged Pregnancy, Sleep Disturbance, Depression
- 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
- 7 Jun 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 21 Dec 2017 (actual)
- 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.
Randomised trial comparing double balloon catheter for induction of labor between inpatient and outpatient groups. The investigators assess how sleep disturbances and depression of the mother affect to the pain during balloon catheter induction of labour.
Detailed description
Participants included to this randomised study are women with uncomplicated singleton pregnancy with ≥ 37- ≤ 41+5 weeks of gestation. Participants are randomised to two groups: one hundred are randomised 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 investigators assess also the effect of the sleep disturbance and depression of the mother to the pain during balloon catheter induction of the labour.
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
- Model description
- Factorial assignment
| Arm | Type | Receives |
|---|---|---|
| Outpatient group | Active comparator | Other: Intervention for outpatient group was to go homeAfter insertion of induction catheter for labor, women of the outpatient group can go home and assess their pain with visual analogy scale at home. The intervention is to go home. Intervention for outpatient group was to go home. |
| Inpatient group | Placebo comparator | Other: Intervention for inpatient group was to stay at wardAfter insertion of induction catheter for labor, women of the inpatient group assess their pain with visual analogy scale in the ward. The intervention is to stay at ward. Intervention for inpatient group was to stay at ward. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- uncomplicated pregnancy
- singleton pregnancy
- pregnancy weeks ≥ 37 - ≤ 41+5
- the patient is living in1/2 hour away from hospital
Key exclusion criteria (7 listed)
- patient has a disease that is effecting to the pregnancy e.g. pre-eclampsia, gestational hepatosis
- the patient has medical treatment of diabetes
- baby is not growing normally
- multiple pregnancy
- preterm rupture of membranes
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 for outpatient group was to go homeAlso: Intervention was to assess the pain by visual analogy scale.Intervention for outpatient group was to go home and assess the the pain | Other | Outpatient group |
| Intervention for inpatient group was to stay at wardAlso: Intervention was to assess the pain by visual analogy scale.Intervention for inpatient group was to stay at ward and assess the pain | Other | Inpatient group |
Primary outcome
The pain measured by VAS
Time frame: one to 14 days after induction of the labor
The pain measured by VAS after double balloon catheter insertion.
4 secondary outcomes
The affect of the sleep disturbances of the mother to the pain assessed by VAS
Time frame: one to 14 days after induction of the labor
The effect of depression of the mother to the pain assessed by VAS
Time frame: one to 14 days after induction of the labor
The total hospital stay in both groups
Time frame: one to 14 days after induction of the labor
The maternal and neonatal morbidity after balloon catheter induction
Time frame: one to 14 days after induction of the labor
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 11 Jun 2020.
- 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.
- Results publication: 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.
- Results publication: 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.
- Individual participant dataSharing planned: No. Letter to patients
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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.
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 for outpatient group was to go home and Intervention for inpatient group was to stay at ward in people with Prolonged Pregnancy and Sleep Disturbance, 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 7 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 11 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. Some participants in this study may receive a placebo. 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 VAS (time frame: one to 14 days after induction of the labor). 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 NCT03380897, which also lists 3 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 11 Jun 2020.