Outpatient Induction of Labour Using Intracervical Foley Catheter (OFC)

Hospital Kemaman

Status: Terminated

Conditions: Induction of Labor Affected Fetus / Newborn; Pregnancy Related

Treatments: Device: Foley catheter; Drug: Intravaginal prostaglandin E2

Study type: Interventional

Funder types: Other

Identifiers

NCT05622968

NMRR ID-22-00349-EQQ

Details and patient eligibility

About

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)

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 year old
• Singleton pregnancy
• Cephalic presentation
• Multiparous women in their 2nd to 5th pregnancy (Para 1 to 4)
• Gestational age between 37+0 and 41+0 weeks.
• No previous uterine surgery (lower segment caesarean section, upper segment caesarean section, myomectomy
• Resides within 30 minutes drive from Hospital Kemaman
• Has access to a telephone
• Has reliable transportation (i.e. able to get to the hospital immediately without the need of ambulance)
• Acceptance of participation by the signing of a written consent.

Exclusion criteria

• Pregnancy with non-cephalic presentation
• Prior cesarean delivery
• Gestational hypertension or preeclampsia on 2 or more medications
• Diabetes in pregnancy on high dose medication(s); insulin of more than 60 units per day or combination of insulin and oral hypoglycemic agent
• Low lying placenta or placenta praevia
• Rupture of amniotic membrane
• Primiparae and grandmultiparae (para 5 or more)
• Multiple pregnancy
• Fetal death
• Fetal anomalies: defined as the presence of a major fetal anomaly of any organ system
• Fetal growth restriction: defined as an ultrasound derived estimated fetal weight less than the 10th percentile for gestational age
• Suspected macrosomia: defined as an ultrasound derived estimated fetal weight of more than 90th centile for gestational age
• Oligohydramnios: ultrasound measured amniotic fluid index (AFI) less than the 10th percentile for gestational age
• Polyhydramnios: defined as an AFI of 24 cm or greater or a single deepest vertical pocket of 8 cm or greater
• Latex allergy
• Contraindication to induction of labor
• Evidence of active phase of labor

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

Women who are planned for elective delivery for obstetric indication(s) and undergo outpatient induction of labour using Foley catheter

Treatment:

Drug: Intravaginal prostaglandin E2

Device: Foley catheter

Control

Placebo Comparator group

Description:

Women who are planned for elective delivery for obstetric indication(s) and undergo inpatient induction of labour using intravaginal prostaglandin

Treatment:

Drug: Intravaginal prostaglandin E2