Outpatient Induction of Labour Using Intracervical Foley Catheter

Study Overview
=================
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.

Official Title
-----------------
Outpatient Cervical Ripening With Foley Catheter for Induction of Labour in Low Risk Women: a Quasi-experimental Study (OFC Study)

Conditions
-----------------
Pregnancy Related, Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
-----------------
* Device: Foley catheter
* Drug: Intravaginal prostaglandin E2


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Women who are planned for elective delivery for obstetric indication(s) and undergo outpatient induction of labour using Foley catheter | Device: Foley catheter<br>* Insertion of 18G Foley catheter into the cervical canal and inflating the balloon to 60 mls using sterile water<br>* Other names: urinary catheter;Drug: Intravaginal prostaglandin E2<br>* Insertion of intravaginal Dinoprostone<br>* Other names: Dinoprostone;|
| Placebo Comparator: Control<br>Women who are planned for elective delivery for obstetric indication(s) and undergo inpatient induction of labour using intravaginal prostaglandin | Drug: Intravaginal prostaglandin E2<br>* Insertion of intravaginal Dinoprostone<br>* Other names: Dinoprostone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Induction of labour (intravaginal prostaglandin) to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of induction of labour within 12 hours | The percentage of vaginal delivery within 12 hours of inpatient cervical ripening | 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 | From the start of inpatient cervical ripening and delivery | 
| Delivery outcome | Percentage of caesarean section and instrumental delivery | Induction to delivery | 
| Adverse event | Incidence of uterine tachysystole and hyperstimulation | Induction to delivery | 
| Labour augmentation | Duration and maximum oxytocin dose used for labour augmentation | Induction to delivery | 
| Maximum pain recorded | Maximum recorded contraction pain during cervical ripening (using Visual Analogue Scale of 10) | Induction to delivery | 
| Incidence of chorioamnionitis | 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 | Induction to 24 hours after delivery | 
| Analgesia requirement | Prevalence of analgesia required during induction of labour | Induction to delivery | 
| Postpartum hemorrhage | Primary postpartum haemorrhage (blood loss of more than 500mls within 24 hours of delivery) | Delivery to 24 hours after delivery | 
| Neonatal Apgar score | Incidence of low Apgar score (less than 7) at 5 minutes after delivery | Delivery to 10 minutes after birth | 
| Neonatal intubation | Incidence of neonates requiring intubation | Delivery to 30 minutes after birth | 
| Neonatal seizure | Incidence of neonate with seizure | Delivery to 24 hours after birth | 
| Neonatal complication | Admission to the Neonatal Intensive Care Unit | Delivery to 24 hours after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
outpatient induction, Foley catheter