Comparison of 6-hour versus 12-hour insertion of single-balloon catheters combined with oxytocin administration for labor induction

Randomized, Multicenter, Controlled Trial to Compare Six versus Twelve-hour Single Balloon Catheter Insertion Following Oxytocin Induction for Labor Induction (RCT-SBCI-Oxytocin Trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230809059096N3

Enrollment

200

Registered

2025-01-17

Start date

2024-12-21

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Full-term uncomplicated delivery. Encounter for full-term uncomplicated delivery

Interventions

Intervention 1: Intervention group 1: An 18-gauge Foley catheter will be fixed into the cervix and induction will begin after one hour with 2 milliunits of oxytocin. The Foley catheter will be removed

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Age 18 to 40 years Term gestational age Singleton pregnancy Cephalic presentation Bishop score less than or equal to 6 Cervical dilation less than 2 cm

Exclusion criteria

Exclusion criteria: Any contraindication to vaginal delivery Previous history of cesarean delivery Rupture of the membranes Any communication disorder (such as inability to speak the official language of the country/mental retardation/deafness or muteness)

Design outcomes

Primary

Measure	Time frame
Determining the rate of vaginal delivery. Timepoint: 24 hours. Method of measurement: physical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Javad Najafi

Mazandaran University of Medical Sciences

mjnajafi@rocketmail.com+98 911 223 5772

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026