Labor Induction with Foley catheter and E1-prostaglandin analogs in Poland (LIFE-PL Study)

A prospective quasi-randomized controlled trial evaluating the effectiveness of a pharmacological pre-induction and induction of labor protocol using an oral prostaglandin E1 analogue and oxytocin compared to a protocol of mechanical pre-induction and induction of labor using a single-balloon Foley catheter, and oxytocin in patients scheduled for induction of labor

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN89250117

Enrollment

300

Registered

2024-01-05

Start date

2023-11-23

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparison of the effectiveness and safety of two pre-induction and labor induction regimens Pregnancy and Childbirth

Interventions

The study will include an assessment and comparison of the effectiveness of two popular methods of labor pre-induction: Foley catheter (mechanical method) and oral E1-prostaglandin analogues (pharmaco

Eligibility

Sex/Gender

Female

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Time from labor induction regimen administration to delivery (both vaginal and cesarean) within 24–48 h measured using patient records	—

Secondary

Measure	Time frame
Measured using patient records at the end of the study: 1. Proportion of women undergoing cesarean section or operative delivery 2. Oxytocin augmentation 3. Necessity for intrapartum analgesia application 4. Number of vaginal births and of cesarean sections 5. Clinical condition of patients and newborns 6. Occurrence of uterine hyperstimulation (tachysystole)	—

Countries

Poland

Contacts

Public ContactMaciej;Wojciech Socha;Flis

;

msocha@copernicus.gda.pl;wflis@copernicus.gda.pl+48-691-633-390;+48-505-328-902

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026