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)
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Insertion of 18G Foley catheter into the cervical canal and inflating the balloon to 60 mls using sterile water
Insertion of intravaginal Dinoprostone
Hospital Kemaman
Kampong Kemaman, Terengganu, Malaysia
Induction of labour-delivery interval
The mean interval between the start of inpatient cervical ripening and delivery (from the start of cervical ripening with Dinoprostone to the delivery of the baby)
Time frame: Induction of labour (intravaginal prostaglandin) to delivery
Success rate of induction of labour within 12 hours
The percentage of vaginal delivery within 12 hours of inpatient cervical ripening
Time frame: From the start of inpatient cervical ripening and delivery
Success rate of induction of labour within 24 hours
The percentage of vaginal delivery within 24 hours of inpatient cervical ripening
Time frame: From the start of inpatient cervical ripening and delivery
Delivery outcome
Percentage of caesarean section and instrumental delivery
Time frame: Induction to delivery
Adverse event
Incidence of uterine tachysystole and hyperstimulation
Time frame: Induction to delivery
Labour augmentation
Duration and maximum oxytocin dose used for labour augmentation
Time frame: Induction to delivery
Maximum pain recorded
Maximum recorded contraction pain during cervical ripening (using Visual Analogue Scale of 10)
Time frame: Induction to delivery
Incidence of chorioamnionitis
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maternal temperature is greater than or equal to 39.0°C or when the maternal temperature is 38.0-38.9°C and one additional clinical risk factor is present
Time frame: Induction to 24 hours after delivery
Analgesia requirement
Prevalence of analgesia required during induction of labour
Time frame: Induction to delivery
Postpartum hemorrhage
Primary postpartum haemorrhage (blood loss of more than 500mls within 24 hours of delivery)
Time frame: Delivery to 24 hours after delivery
Neonatal Apgar score
Incidence of low Apgar score (less than 7) at 5 minutes after delivery
Time frame: Delivery to 10 minutes after birth
Neonatal intubation
Incidence of neonates requiring intubation
Time frame: Delivery to 30 minutes after birth
Neonatal seizure
Incidence of neonate with seizure
Time frame: Delivery to 24 hours after birth
Neonatal complication
Admission to the Neonatal Intensive Care Unit
Time frame: Delivery to 24 hours after birth