Clinical trial NCT05622968: Outpatient Induction of Labour Using Intracervical Foley Catheter
Official title: Outpatient Cervical Ripening With Foley Catheter for Induction of Labour in Low Risk Women: a Quasi-experimental Study (OFC Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy Related
Induction of Labor Affected Fetus / Newborn
Keywords: outpatient induction
Foley catheter
Lead sponsor: Hospital Kemaman
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Induction of labour-delivery interval
timeFrame: Induction of labour (intravaginal prostaglandin) to delivery
Secondary outcomes:
measure: Success rate of induction of labour within 12 hours
timeFrame: From the start of inpatient cervical ripening and delivery
measure: Success rate of induction of labour within 24 hours
timeFrame: From the start of inpatient cervical ripening and delivery
measure: Delivery outcome
timeFrame: Induction to delivery
measure: Adverse event
timeFrame: Induction to delivery
measure: Labour augmentation
timeFrame: Induction to delivery
measure: Maximum pain recorded
timeFrame: Induction to delivery
measure: Incidence of chorioamnionitis
timeFrame: Induction to 24 hours after delivery
measure: Analgesia requirement
timeFrame: Induction to delivery
measure: Postpartum hemorrhage
timeFrame: Delivery to 24 hours after delivery
measure: Neonatal Apgar score
timeFrame: Delivery to 10 minutes after birth
measure: Neonatal intubation
timeFrame: Delivery to 30 minutes after birth
measure: Neonatal seizure
timeFrame: Delivery to 24 hours after birth
measure: Neonatal complication
timeFrame: Delivery to 24 hours after birth
Other outcomes:
Locations:
city: Kampong Kemaman
country: Malaysia
facility: Hospital Kemaman
state: Terengganu
Study officials:
affiliation: Hospital Kemaman
name: Zahar Zakaria, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Royal College of Obstetricians and Gynaecologists. Evidence-based Clinical Guideline No. 9. Induction of labour
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