Induced DeliveriesPhase 4NCT02918110
Vaginal Misodel® in Comparison With Orally Administrated Misoprostol (Cytotec®) at Induction of Labour
A Phase 4 study testing Misoprostol in people with Induced Deliveries, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The study will compare orally administrated solution of Misoprostol (Cytotec®) with vaginal slow release (7ug/h) Misoprostol (Misodel®) regarding efficacy and safety during labour. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Induced Deliveries
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2016to Sep 2017
- Phase
- Phase 4
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primipara BS ≤ 4p Gestational week >37
Who cannot join
- Multipara Multiples Gestational week <37 BS >4 IUFD Previous uterine surgery
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Eva Wiberg-Itzel
Stockholm, 18239
Eva Wiberg-Itzel, Professor, +4686163768, eva@itzel.eu
Per Tornvall, Professor, +4686161000, per@tornvall.ki
About this study
The study will compare orally administrated solution of Misoprostol (Cytotec®) with vaginal slow release (7ug/h) Misoprostol (Misodel®) regarding efficacy and safety during labour.
Read the detailed description
To compare orally administrated solution of misoprostol (Cytotec®) with vaginal slow release misoprostol (Misodel®) regarding efficacy and safety during labour Design: Randomised controlled trial (RCT)
Settings:
Obstetric departments of Sodersjukhuset, Stockholm Obstetric departments of Women's clinic, Karlstad.
- Conditions
- Induced Deliveries
- Being tested
- Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
Women needed to be induced will get orally administrated solution of misoprostol (Cytotec®) or vaginal slow release misoprostol (Misodel®)
| Study group | Role | What they receive |
|---|---|---|
| Cytotec | Experimental | orally administrated solution of misoprostol (Cytotec®) Receives: Drug: Misoprostol |
| Misodel | Experimental | vaginal slow release misoprostol (Misodel®) Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean section rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
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 Induced DeliveriesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karlstad Central Hospital
- Responsible party
- Principal investigator, Eva Wiberg-Itzel, Karolinska Institutet
- Investigators
- Per Tornvall, Prof, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918110
- Sponsor's protocol ID
- 1cyt
- Status last verified
- Sep 2016
- First submitted
- 27 Sep 2016
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Strandberg M, Wallstrom T, Wiberg-Itzel E. Women's expectations and experiences of labor induction - a questionnaire-based analysis of a randomized controlled trial. BMC Pregnancy Childbirth. 2021 May 4;21(1):355. doi: 10.1186/s12884-021-03786-6.
PubMed 33947349
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Misodel® in Comparison With Orally Administrated Misoprostol (Cytotec®) at Induction of Labour
- ClinicalTrials.gov ID
- NCT02918110
- Acronym / sponsor ID
- 1cyt
- Conditions
- Induced Deliveries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karlstad Central Hospital
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 28 Sep 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 study will compare orally administrated solution of Misoprostol (Cytotec®) with vaginal slow release (7ug/h) Misoprostol (Misodel®) regarding efficacy and safety during labour.
Detailed description
To compare orally administrated solution of misoprostol (Cytotec®) with vaginal slow release misoprostol (Misodel®) regarding efficacy and safety during labour Design: Randomised controlled trial (RCT)
Settings:
Obstetric departments of Sodersjukhuset, Stockholm Obstetric departments of Women's clinic, Karlstad.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cytotec | Experimental | Drug: Misoprostolorally administrated solution of misoprostol (Cytotec®) |
| Misodel | Experimental | Drug: Misoprostolvaginal slow release misoprostol (Misodel®) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Primipara BS ≤ 4p Gestational week >37
Key exclusion criteria (1 listed)
- Multipara Multiples Gestational week <37 BS >4 IUFD Previous uterine surgery
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 |
|---|---|---|
| MisoprostolAlso: CytotecWomen needed to be induced will get orally administrated solution of misoprostol (Cytotec®) or vaginal slow release misoprostol (Misodel®) | Drug | Cytotec, Misodel |
Primary outcome
Cesarean section rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Derived from this study: PubMed 33947349Strandberg M, Wallstrom T, Wiberg-Itzel E. Women's expectations and experiences of labor induction - a questionnaire-based analysis of a randomized controlled trial. BMC Pregnancy Childbirth. 2021 May 4;21(1):355. doi: 10.1186/s12884-021-03786-6.
- Individual participant dataSharing planned: No
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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.
Per Tornvall, Prof study director
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol in people with Induced Deliveries, run by Karolinska Institutet at 1 site in Sweden.
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 28 Sep 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 Sweden. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Eva Wiberg-Itzel, Professor (708775346, eva.itzel@telia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean section rate (time frame: 1 year). 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 NCT02918110, 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 Sep 2016.