Efficacy of intracervical foley catheter insertion with vaginal dinoprostone VS vaginal dinoprostone for induction of labor: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250102003

Enrollment

Registered

2025-01-02

Start date

2024-10-22

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

induction of labor induction of labor, intracervical Foley catheter, vaginal dinoprostone

Interventions

intracervical Foley catheter insertion combine with vaginal dinoprostone for induction of labor,vaginal dinoprostone alone for induction of labor

Experimental Other,Active Comparator Drug

Intracervical Foley catheter insertion with vaginal dinoprostone,vaginal dinoprostone

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1.Singleton pregnancy aged 18-45 years, 2.indicated for induction of labor such as post-date oligohydramnios fetal IUGR DFIU Gestational hypertension and diabetes, 3.Gestaional aged 28-41+6 weeks confirmed by ultrasound, 4.fetus in cephalic presentation with bishop score < 3 without good uterine contraction (3 times in 10 minutes)

Exclusion criteria

Exclusion criteria: 1. Pregnant women who have contraindications to vaginal birth : previous uterine scar placenta previa fetal malpresentation, 2. Pregnant women who have immediate delivery indication such as abruptio placentae hemodynamic unstable, 3. allergy to prostaglandin

Design outcomes

Primary

Measure	Time frame
duration to active phase of labor record stating time from induction of labor until active phase of labor times (hours/minutes)	—

Secondary

Measure	Time frame
duration to delivery record stating time from induction of labor until baby is delivered times (hours/minutes),rate of cesarean section record after delivery is completed case,rate of amniotomy record after delivery is completed case,rate of oxytocin used record after delivery is completed case,rate of vaginal instrument for delivery record after delivery is completed case,Rate of chorioamnionitis record after delivery is completed case,rate of maternal tachysystole record after delivery is completed case,Rate of fetal non-reassuring record after delivery is completed case,APGAR score of a baby record after delivery is completed score 0-10,Rate of postpartum endometritis record after patient have endometritis condition case,rate of meconium-stained amniotic fluid record after delivery is completed case,rate of NICU admission record after delivery is completed case,Satisfaction score recorecord after delivery is completed score 0-10 (10 most satisfy, 0 unsatify)	—

Measure

Time frame

duration to delivery record stating time from induction of labor until baby is delivered times (hours/minutes),rate of cesarean section record after delivery is completed case,rate of amniotomy record after delivery is completed case,rate of oxytocin used record after delivery is completed case,rate of vaginal instrument for delivery record after delivery is completed case,Rate of chorioamnionitis record after delivery is completed case,rate of maternal tachysystole record after delivery is completed case,Rate of fetal non-reassuring record after delivery is completed case,APGAR score of a baby record after delivery is completed score 0-10,Rate of postpartum endometritis record after patient have endometritis condition case,rate of meconium-stained amniotic fluid record after delivery is completed case,rate of NICU admission record after delivery is completed case,Satisfaction score recorecord after delivery is completed score 0-10 (10 most satisfy, 0 unsatify)

—

Countries

Thailand

Contacts

Public ContactPasuk Songserm

Sunpasitthiprasong Hospital

Pasuk@kkumail.com0894247757

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026