Induction of Labor Affected Fetus / Newborn, Pregnancy Related
Conditions
Keywords
outpatient induction, Foley catheter
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.
Interventions
DEVICEFoley catheter
Insertion of 18G Foley catheter into the cervical canal and inflating the balloon to 60 mls using sterile water
DRUGIntravaginal prostaglandin E2
Insertion of intravaginal Dinoprostone
Sponsors
Hospital Kemaman
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Induction of labour-delivery interval | Induction of labour (intravaginal prostaglandin) to delivery | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of induction of labour within 24 hours | From the start of inpatient cervical ripening and delivery | The percentage of vaginal delivery within 24 hours of inpatient cervical ripening |
| Delivery outcome | Induction to delivery | Percentage of caesarean section and instrumental delivery |
| Adverse event | Induction to delivery | Incidence of uterine tachysystole and hyperstimulation |
| Labour augmentation | Induction to delivery | Duration and maximum oxytocin dose used for labour augmentation |
| Maximum pain recorded | Induction to delivery | Maximum recorded contraction pain during cervical ripening (using Visual Analogue Scale of 10) |
| Incidence of chorioamnionitis | Induction to 24 hours after delivery | 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 |
| Success rate of induction of labour within 12 hours | From the start of inpatient cervical ripening and delivery | The percentage of vaginal delivery within 12 hours of inpatient cervical ripening |
| Postpartum hemorrhage | Delivery to 24 hours after delivery | Primary postpartum haemorrhage (blood loss of more than 500mls within 24 hours of delivery) |
| Neonatal Apgar score | Delivery to 10 minutes after birth | Incidence of low Apgar score (less than 7) at 5 minutes after delivery |
| Neonatal intubation | Delivery to 30 minutes after birth | Incidence of neonates requiring intubation |
| Neonatal seizure | Delivery to 24 hours after birth | Incidence of neonate with seizure |
| Neonatal complication | Delivery to 24 hours after birth | Admission to the Neonatal Intensive Care Unit |
| Analgesia requirement | Induction to delivery | Prevalence of analgesia required during induction of labour |
Countries
Malaysia
Outcome results
None listed