Labour InductionNCT02904317
Misoprostol 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) with an off-label use of oral misoprostol (OM). Design: Pair-matched case-control study. Setting: Tertiary-care academic centre in Germany. Population: A cohort of 138 women ≥ 37/0 weeks pregnant undergoing labour induction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labour Induction
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jan 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 women ≥ 37/0 weeks pregnant undergoing labour induction.
Who may be able to join
- gynaecologist'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 previa
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- chorioamnionitis
- antepartum bleeding of unknown aetiology
- cardiopulmonary, renal, hepatic maternal disease glaucoma
- fetal congenital abnormalities
About this study
Official title: The Misoprostol Vaginal Insert Compared With Oral Misoprostol for Labour Induction in Term Pregnancies: a Pair-matched Case-control Study
Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) with an off-label use of oral misoprostol (OM).
Design: Pair-matched case-control study.
Read more
Setting: Tertiary-care academic centre in Germany.
Population: A cohort of 138 women ≥ 37/0 weeks pregnant undergoing labour induction.
Methods: The induction of labour with a retrievable prostaglandin vaginal insert in a consecutive series of 69 women was compared with induction using oral misoprostol in a pair-matched cohort.
Main outcome measures: The primary outcomes were the time from induction to delivery and the caesarean section rate. Secondary outcomes included uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.
Read the detailed description
Open, non-interventional study in a tertiary referral center in Germany N/A The rationale of our observational study is to describe the efficacy and safety profile of the drug with definition of active labor according to local clinical practice in a descriptive observational study in a tertiary referral center.
A time interval from induction of labor to delivery is depending on the duration of the MISODEL® application. By an observational study the investigators want to describe the efficacy and safety with regard to time to delivery and complication rate.
Primary Objective:
The aim of this study is to describe time to vaginal delivery with definition of active labor according to local clinical practice.
The time period needed to induce any delivery and to describe the drug safety profile.
Primary endpoints:
- Time to vaginal delivery in hours in patients with vaginal delivery.
- Length of time until any delivery
- Caesarean section rate
- Time until onset of labor
- Frequency of vaginal operative delivery
- Frequency of abnormal CTG (Figo)
- Frequency of uterine Tachysystole leading to abnormal fetal heartrate i.e. Figo P. Tachysystole is defined as five or more contractions in 10 minutes averaged over three consecutive 10-minute periods.
- Written informed consent of the patients
- ≥18 years of age
- Parity five or less with singleton pregnancies
- ≥36 weeks of gestation
- Unfavourable cervix (baseline modified Bishop score ≤6)
Misoprostol 200mcg VDS is contraindicated according to the SmPC in the following cases:
- When there is hypersensitivity to the active substance or to any of the excipients
- When labour has started
- When oxytocic drugs and/or other labour induction agents are being given
- When there is suspicion or evidence of uterine scar resulting from previous uterine surgery, e.g. C-section
- When there is uterine abnormality (e.g. bicornate uterus)
- When there is placenta praevia or unexplained vaginal bleeding after 24 weeks gestation with this pregnancy
- When there is foetal malpresentation
- When there are signs or symptoms of chorioamnionitis, unless adequate prior treatment has been instituted
- Before week 36 of gestation
For evaluation of the primary and secondary endpoints of the study, descriptive statistical methods will be used.
- Conditions
- Labour Induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Misprostol vaginal insert for labour induction | 69 patients matching the inclusion criteria and received MVI for labour induction | |
| Oral misoprostol for labour induction | 69 patients matching the inclusion criteria and received OM for labour induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
time from application of the medication until delivery in minutes
Measured: September 2015
Secondary outcomes (4)
Rate of participants receiving a caesarean section compared to all participants being induced
Measured: September 2015
Number of participants with treatment-related tachysystole as assessed by cardiotocography
Measured: September 2015
Number of participants with treatment-related adverse events following tocolysis with Partusisten
Measured: September 2015
Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value
Measured: September 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startAug 2015
- Primary completionSep 2015
- Study completionJan 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
- Case-control
- 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
- NCT02904317
- Sponsor's protocol ID
- PV4803-2
- Status last verified
- Sep 2016
- First submitted
- 3 Aug 2016
- Last updated
- 16 Sep 2016
- 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 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Misoprostol Vaginal Insert Compared With Oral Misoprostol for Labour Induction in Term Pregnancies: a Pair-matched Case-control Study
- ClinicalTrials.gov ID
- NCT02904317
- Acronym / sponsor ID
- PV4803-2
- Conditions
- Labour Induction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Asklepios Kliniken Hamburg GmbHUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 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.
Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) with an off-label use of oral misoprostol (OM).
Design: Pair-matched case-control study.
Setting: Tertiary-care academic centre in Germany.
Population: A cohort of 138 women ≥ 37/0 weeks pregnant undergoing labour induction.
Methods: The induction of labour with a retrievable prostaglandin vaginal insert in a consecutive series of 69 women was compared with induction using oral misoprostol in a pair-matched cohort.
Main outcome measures: The primary outcomes were the time from induction to delivery and the caesarean section rate. Secondary outcomes included uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.
Detailed description
Open, non-interventional study in a tertiary referral center in Germany N/A The rationale of our observational study is to describe the efficacy and safety profile of the drug with definition of active labor according to local clinical practice in a descriptive observational study in a tertiary referral center.
A time interval from induction of labor to delivery is depending on the duration of the MISODEL® application. By an observational study the investigators want to describe the efficacy and safety with regard to time to delivery and complication rate.
Primary Objective:
The aim of this study is to describe time to vaginal delivery with definition of active labor according to local clinical practice.
The time period needed to induce any delivery and to describe the drug safety profile.
Primary endpoints:
- Time to vaginal delivery in hours in patients with vaginal delivery.
- Length of time until any delivery
- Caesarean section rate
- Time until onset of labor
- Frequency of vaginal operative delivery
- Frequency of abnormal CTG (Figo)
- Frequency of uterine Tachysystole leading to abnormal fetal heartrate i.e. Figo P. Tachysystole is defined as five or more contractions in 10 minutes averaged over three consecutive 10-minute periods.
- Written informed consent of the patients
- ≥18 years of age
- Parity five or less with singleton pregnancies
- ≥36 weeks of gestation
- Unfavourable cervix (baseline modified Bishop score ≤6)
Misoprostol 200mcg VDS is contraindicated according to the SmPC in the following cases:
- When there is hypersensitivity to the active substance or to any of the excipients
- When labour has started
- When oxytocic drugs and/or other labour induction agents are being given
- When there is suspicion or evidence of uterine scar resulting from previous uterine surgery, e.g. C-section
- When there is uterine abnormality (e.g. bicornate uterus)
- When there is placenta praevia or unexplained vaginal bleeding after 24 weeks gestation with this pregnancy
- When there is foetal malpresentation
- When there are signs or symptoms of chorioamnionitis, unless adequate prior treatment has been instituted
- Before week 36 of gestation
For evaluation of the primary and secondary endpoints of the study, descriptive statistical methods will be used.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misprostol vaginal insert for labour induction | – | –69 patients matching the inclusion criteria and received MVI for labour induction |
| Oral misoprostol for labour induction | – | –69 patients matching the inclusion criteria and received OM for labour induction |
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 women ≥ 37/0 weeks pregnant undergoing labour induction.
Key inclusion criteria (6 listed)
- gynaecologist's indication for induction
- informed consent
- > 37 weeks of gestation
- singleton pregnancies
- cephalic presentation
Key exclusion criteria (10 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.
Primary outcome
time from application of the medication until delivery in minutes
Time frame: September 2015
4 secondary outcomes
Rate of participants receiving a caesarean section compared to all participants being induced
Time frame: September 2015
Number of participants with treatment-related tachysystole as assessed by cardiotocography
Time frame: September 2015
Number of participants with treatment-related adverse events following tocolysis with Partusisten
Time frame: September 2015
Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value
Time frame: September 2015
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 16 Sep 2016.
- 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 10 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 16 Sep 2016. 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 application of the medication until delivery in minutes (time frame: September 2015). 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 16 Sep 2016.