abor Induction with Foley catheter and E1-prostaglandin analogs in Poland (LIFE-PL Study)
- Conditions
- Comparison of the effectiveness and safety of two pre-induction and labor induction regimensRespiratory
- Registration Number
- ISRCTN89250117
- Lead Sponsor
- Department of Obstetrics and Gynecology, St. Adalbert’s Hospital in Gdansk, Copernicus Healthcare Entity
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 300
1. Single live pregnancy
2. Cephalic fetal presentation
3. No history of previous uterine operations (i.e. cesarean section)
4. Indications for induction of labor in accordance with current recommendations of the Polish Society of Gynecologists and Obstetricians
5. Lack of contraindications to vaginal delivery
6. Confirmed well-being of the mother and fetus
7. Informed consent to participate in the study
8. Unfavourable cervix
9. Full-term pregnancy (>37 weeks of pregnancy)
1. Presence of uterine scar
2. Onset of spontaneous labor
3. Premature rupture of membranes (PROM)
4. Non-cephalic fetal position
5. Multiple pregnancy
6. Suspected intrauterine infection
7. Contraindications to vaginal delivery and induction of labor following the Polish guidelines
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time from labor induction regimen administration to delivery (both vaginal and cesarean) within 24–48 h measured using patient records
- Secondary Outcome Measures
Name Time Method Measured using patient records at the end of the study:<br>1. Proportion of women undergoing cesarean section or operative delivery<br>2. Oxytocin augmentation<br>3. Necessity for intrapartum analgesia application<br>4. Number of vaginal births and of cesarean sections<br>5. Clinical condition of patients and newborns<br>6. Occurrence of uterine hyperstimulation (tachysystole)