NCT05622968

Outpatient Induction of Labour Using Intracervical Foley Catheter

Outpatient Cervical Ripening With Foley Catheter for Induction of Labour in Low Risk Women: a Quasi-experimental Study (OFC Study)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Hospital Kemaman · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Prospective quasi-experimental study between a study population who will receive outpatient induction of labour using intracervical Foley catheter, followed by the inpatient induction using intravaginal prostaglandin and a control group of women with similar characteristics undergoing inpatient labour induction with intravaginal prostaglandin (standard management)

Detailed description

The study will be conducted among pregnant women in 2 to 5th pregnancy who have no significant risk factors and planned for induction of labour. The eliiable women will be recruited from 4 health clinics within the district (of Kemaman, Malaysia) and located within 20 km from the hospital. Willing participants will be seen in the hospital at the planned induction date and reassessed. Should they be suitable for induction of labour using Foley catheter on outpatient basis, a 18G Foley catheter will be inserted into the cervical canal and the balloon inflated with sterile water (60 mls). The fetal well being will be assessed and the women allowed to go home with instruction related to the induction and the study. Those who do not enter the active phase of labour will be admitted to the ward 24 hours later and will undergo inpatient induction of labour using intravaginal prostaglandin (Dinoprostone) according to the local protocol. These women will be compared with a control group comprising of women with similar characteristics and undergo inpatient induction of labour with intravaginal Dinoprostone.

Conditions

• Pregnancy Related
• Induction of Labor Affected Fetus / Newborn

Interventions

Type	Name	Description
DEVICE	Foley catheter	Insertion of 18G Foley catheter into the cervical canal and inflating the balloon to 60 mls using sterile water
DRUG	Intravaginal prostaglandin E2	Insertion of intravaginal Dinoprostone

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2022-11-21
• Last updated: 2025-01-17

Locations

1 site across 1 country: Malaysia