Labour InductionPhase 4NCT02539199
Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour
A Phase 4 study testing Misoprostol, modified-release pessary and Misoprostol, per-oral tablets in people with Labour Induction, run by Tampere University Hospital at 5 sites in Finland.
Trial summary
The purpose of this study is to investigate the effectiveness and safety of vaginally administered misoprostol (Misodel) versus per orally administered misoprostol (Cytotec) in induction of labour in nulliparous women. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Labour Induction
- What is being tested?
- Misoprostol, modified-release pessary and Misoprostol, per-oral tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 5 sitesFinland
- Study dates
- Sep 2015to 2 Mar 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Nulliparous
- Singleton at term pregnancy (>36+6 weeks)
- Unfavourable cervix (Bishop score < 6)
- Fetal cephalic position
Who cannot join
- Pre-term pregnancy (<37 weeks)
- Multiple pregnancy
- Rupture of membranes
- Other than fetal cephalic position
- Intra-uterine growth retardation
- Severe pre-eclampsia
- Severe hypertension
- Previous cesarean section
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites
Helsinki University hospital
Helsinki
Kuopio University Hospital
Kuopio
Oulu University Hospital
Oulu
Tampere University Hospital
Tampere
Turku University Hospital
Turku
About this study
Official title: Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour: a Randomized Trial
The purpose of this study is to investigate the effectiveness and safety of vaginally administered misoprostol (Misodel) versus per orally administered misoprostol (Cytotec) in induction of labour in nulliparous women.
- Conditions
- Labour Induction
- Being tested
- Misoprostol, modified-release pessary, Misoprostol, per-oral tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol, modified-release pessaryDrug
Also called Misodel
Misoprostol pessary (7 ug/h) placed in vaginal fornix until labour is induced or maximum 24 hours
Misoprostol, per-oral tabletsDrug
Also called Cytotec
First day: 50 ug PO in every 4 hours maximum 3 times per day. Second day: 100 ug PO in every 4 hours maximum 3 times per day. Third day: 50 ug vaginally in every 4 hours maximum 3 times per day or until labour is induced.
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol modified-release pessary | Active comparator | Not described Receives: Drug: Misoprostol, modified-release pessary |
| Misoprostol, per-oral tablets | Active comparator | Not described Receives: Drug: Misoprostol, per-oral tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean section rate
Measured: at time of child birth
Secondary outcomes (2)
The time from beginning of induction to child birth
Measured: up to child birth
Neonatal Apgar score
Measured: 1, 5, 10 minutes after child birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion2 Mar 2018
- Study completion2 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour InductionStudies of the same condition, open and under way.
- More trials run by Tampere 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Oulu University Hospital
- Responsible party
- Sponsor
- Investigators
- Kati Tihtonen, PhD, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539199
- Sponsor's protocol ID
- R15109M
- Other IDs
- 2015-001972-23, 2015
- Status last verified
- Apr 2018
- First submitted
- 31 Aug 2015
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02539199
- Acronym / sponsor ID
- R15109M
- Conditions
- Labour Induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Oulu University Hospital
- Study start
- Sep 2015
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 2 Sep 2015 (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 purpose of this study is to investigate the effectiveness and safety of vaginally administered misoprostol (Misodel) versus per orally administered misoprostol (Cytotec) in induction of labour in nulliparous women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol modified-release pessary | Active comparator | Drug: Misoprostol, modified-release pessary |
| Misoprostol, per-oral tablets | Active comparator | Drug: Misoprostol, per-oral tablets |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Nulliparous
- Singleton at term pregnancy (>36+6 weeks)
- Unfavourable cervix (Bishop score < 6)
- Fetal cephalic position
Key exclusion criteria (8 listed)
- Pre-term pregnancy (<37 weeks)
- Multiple pregnancy
- Rupture of membranes
- Other than fetal cephalic position
- Intra-uterine growth retardation
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 |
|---|---|---|
| Misoprostol, modified-release pessaryAlso: MisodelMisoprostol pessary (7 ug/h) placed in vaginal fornix until labour is induced or maximum 24 hours | Drug | Misoprostol modified-release pessary |
| Misoprostol, per-oral tabletsAlso: CytotecFirst day: 50 ug PO in every 4 hours maximum 3 times per day. Second day: 100 ug PO in every 4 hours maximum 3 times per day. Third day: 50 ug vaginally in every 4 hours maximum 3 times per day or until labour is induced. | Drug | Misoprostol, per-oral tablets |
Primary outcome
Cesarean section rate
Time frame: at time of child birth
2 secondary outcomes
The time from beginning of induction to child birth
Time frame: up to child birth
Neonatal Apgar score
Time frame: 1, 5, 10 minutes after child birth
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 18 Apr 2018.
Related trials for Labour Induction
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
Active, not recruiting
Calcium Carbonate on Labor Induction
Pregnancy, Uterine Contraction
Not yet recruiting
The WAIT Trial: Waiting Versus Active Induction at Term in Women With A1 Gestational Diabetes Mellitus
Gestational Diabetes Mellitus (GDM)
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.
Kati Tihtonen, PhD, MD principal investigator
Tampere University Hospital
5 sites 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, modified-release pessary and Misoprostol, per-oral tablets in people with Labour Induction, run by Tampere University Hospital at 5 sites 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 8 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
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?
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?
Cesarean section rate (time frame: at time of child birth). 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 18 Apr 2018.