Labour InductionNCT03016208
The Misoprostol Vaginal Insert for Labour Induction
An observational study of Labour Induction, run by Asklepios Kliniken Hamburg GmbH.
Trial summary
Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for labour induction using standard (MVI-24) and adjusted (MVI-10) criteria. Design: Non-interventional observational case control study. Setting: Tertiary-care academic centre in Germany. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labour Induction
- What is being tested?
- Misoprostol vaginal insert
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2016
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.
Who may be able to join
- gynecologist's indication for induction
- informed consent
- ≥ 37 weeks of gestation
- singleton pregnancies
- cephalic presentation
- cervical Bishop score of < 5 before priming reassuring fetal heart rate
Who cannot join
- known hypersensitivity to prostaglandins
- uterine scar
- parity > 5
- any contraindication for vaginal delivery
- cephalopelvic disproportion
- placenta praevia
Show all 11Show fewer
- chorioamnionitis
- antepartum bleeding of unknown etiology
- cardiopulmonary, renal, hepatic maternal disease
- glaucoma
- fetal congenital abnormalities
About this study
Official title: The Misoprostol Vaginal Insert Used in Standard Compared With Adjusted Criteria for Labour Induction in Term Pregnancies: a Non-interventional Case Control Study
Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for labour induction using standard (MVI-24) and adjusted (MVI-10) criteria.
Design: Non-interventional observational case control study.
Read more
Setting: Tertiary-care academic centre in Germany.
Population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.
Methods: Induction of labour with MVI in a consecutive series of women using standard (MVI-24, n = 69) or adjusted (MVI-10, n = 69) criteria.
Main outcome measures: The primary outcomes were the time from induction to delivery and the caesarean section rate. The secondary outcomes included the need for additional measures to induce labour, uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.
- Conditions
- Labour Induction
- Being tested
- Misoprostol vaginal insert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol vaginal insertDrug
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol vaginal insert for max. 24hrs | 69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 24 hours Receives: Drug: Misoprostol vaginal insert | |
| Misoprostol vaginal insert for max. 10hrs | 69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 10 hours Receives: Drug: Misoprostol vaginal insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from induction to delivery in minutes
Measured: August 2016
Rate of participants receiving a caesarean section compared to all participants being induced
Measured: August 2016
Secondary outcomes (3)
Number of participants with treatment-related tachysystole as assessed by cardiotocography
Measured: August 2016
Number of participants with treatment-related adverse events following tocolysis with Partusisten
Measured: August 2016
Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value
Measured: August 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionMay 2016
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.
- 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
- Observational
- Observational model
- Cohort
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepios Kliniken Hamburg GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Schwaerzler, Asklepios Kliniken Hamburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016208
- Sponsor's protocol ID
- Miso2017
- Status last verified
- Jan 2017
- First submitted
- 8 Jan 2017
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Misoprostol Vaginal Insert Used in Standard Compared With Adjusted Criteria for Labour Induction in Term Pregnancies: a Non-interventional Case Control Study
- ClinicalTrials.gov ID
- NCT03016208
- Acronym / sponsor ID
- Miso2017
- Conditions
- Labour Induction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Asklepios Kliniken Hamburg GmbHUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Jan 2017 (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.
Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for labour induction using standard (MVI-24) and adjusted (MVI-10) criteria.
Design: Non-interventional observational case control study.
Setting: Tertiary-care academic centre in Germany.
Population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.
Methods: Induction of labour with MVI in a consecutive series of women using standard (MVI-24, n = 69) or adjusted (MVI-10, n = 69) criteria.
Main outcome measures: The primary outcomes were the time from induction to delivery and the caesarean section rate. The secondary outcomes included the need for additional measures to induce labour, uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol vaginal insert for max. 24hrs | – | Drug: Misoprostol vaginal insert69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 24 hours |
| Misoprostol vaginal insert for max. 10hrs | – | Drug: Misoprostol vaginal insert69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 10 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.
Key inclusion criteria (6 listed)
- gynecologist's indication for induction
- informed consent
- ≥ 37 weeks of gestation
- singleton pregnancies
- cephalic presentation
Key exclusion criteria (11 listed)
- known hypersensitivity to prostaglandins
- uterine scar
- parity > 5
- any contraindication for vaginal delivery
- cephalopelvic disproportion
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 vaginal insert | Drug | Misoprostol vaginal insert for max. 10hrs, Misoprostol vaginal insert for max. 24hrs |
Primary outcome
Time from induction to delivery in minutes
Time frame: August 2016
Rate of participants receiving a caesarean section compared to all participants being induced
Time frame: August 2016
3 secondary outcomes
Number of participants with treatment-related tachysystole as assessed by cardiotocography
Time frame: August 2016
Number of participants with treatment-related adverse events following tocolysis with Partusisten
Time frame: August 2016
Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value
Time frame: August 2016
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 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Labour Induction
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)
Not yet recruitingObservational study
Prediction of Intrapartum Fetal Compromise After Elective Induction of Labour
Intrapartum Fetal Distress
Not yet recruitingObservational study
Comparative Analysis of Labor Induction Using a Balloon Catheter at Home Versus in the Hospital
Pregnancy
Not yet recruiting
The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Labour Induction, run by Asklepios Kliniken Hamburg GmbH.
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 6 inclusion and 11 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 Jan 2017. 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?
Time from induction to delivery in minutes (time frame: August 2016). The study lists 2 primary outcomes in all. 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 11 Jan 2017.