Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-28 @ 4:56 PM
Study NCT ID:
NCT05622968
Status:
TERMINATED
Last Update Posted:
2025-01-17
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outpatient Induction of Labour Using Intracervical Foley Catheter
Sponsor:
Hospital Kemaman
Organization:
Study Overview
Official Title:
Outpatient Cervical Ripening With Foley Catheter for Induction of Labour in Low Risk Women: a Quasi-experimental Study (OFC Study)
Status:
TERMINATED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OFC
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: