Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
138 participants
OBSERVATIONAL
2015-08-31
2016-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Misoprostol Vaginal Insert for Labour Induction
NCT03016208
Oral Versus Vaginal Misoprostol for Induction of Labor
NCT00148473
Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term
NCT01070472
Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour
NCT00346840
Labor Induction With Oral Versus Vaginal Misoprostol
NCT04755218
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Misprostol vaginal insert for labour induction
69 patients matching the inclusion criteria and received MVI for labour induction
No interventions assigned to this group
Oral misoprostol for labour induction
69 patients matching the inclusion criteria and received OM for labour induction
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* informed consent
* \> 37 weeks of gestation
* singleton pregnancies
* cephalic presentation
* cervical Bishop score of \< 5 before priming reassuring fetal heart rate
Exclusion Criteria
* uterine scar
* parity \> 5
* any contraindication for vaginal delivery
* cephalopelvic disproportion
* placenta previa
* chorioamnionitis
* antepartum bleeding of unknown aetiology
* cardiopulmonary, renal, hepatic maternal disease glaucoma
* fetal congenital abnormalities
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Asklepios Kliniken Hamburg GmbH
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Peter Schwaerzler
Principal investigator
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PV4803-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.