Outpatient Cervical Ripening With Foley Catheter for Induction of Labour in Low Risk Women: a Quasi-experimental Study (OFC Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Induction of labour-delivery interval
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Intervention
Women who are planned for elective delivery for obstetric indication(s) and undergo outpatient induction of labour using Foley catheter
干预措施: Foley catheter (Device)
Intervention
Women who are planned for elective delivery for obstetric indication(s) and undergo outpatient induction of labour using Foley catheter
干预措施: Intravaginal prostaglandin E2 (Drug)
Control
Women who are planned for elective delivery for obstetric indication(s) and undergo inpatient induction of labour using intravaginal prostaglandin
干预措施: Intravaginal prostaglandin E2 (Drug)
结局指标
主要结局
Induction of labour-delivery interval
时间窗: 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)
次要结局
- Incidence of chorioamnionitis(Induction to 24 hours after delivery)
- Labour augmentation(Induction to delivery)
- Analgesia requirement(Induction to delivery)
- Neonatal complication(Delivery to 24 hours after birth)
- Success rate of induction of labour within 12 hours(From the start of inpatient cervical ripening and delivery)
- Success rate of induction of labour within 24 hours(From the start of inpatient cervical ripening and delivery)
- Adverse event(Induction to delivery)
- Neonatal Apgar score(Delivery to 10 minutes after birth)
- Delivery outcome(Induction to delivery)
- Maximum pain recorded(Induction to delivery)
- Postpartum hemorrhage(Delivery to 24 hours after delivery)
- Neonatal intubation(Delivery to 30 minutes after birth)
- Neonatal seizure(Delivery to 24 hours after birth)
研究者
Zahar Azuar Zakaria
Principal Investigator, Head of Obstetric & Gynecology Department, Senior Consultant
Hospital Kemaman