Transcervical Foley catheter combined with a single dose of Dinoprostone gel versus Extra amniotic saline infusion among Women with Oligohydramnios undergoing Induction of Labour – A Randomised study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Proportion of women delivering within 24 hours of induction. Those delivering within 12 hours, beyond 24 hours will also be noted.
研究概览
简要总结
Labour induction is a frequently performed procedure in the management of high risk pregnancy. Induction is carried out generally when the risk of continuing pregnancy outweighs the benefit or at the request of pregnant women. There are many methods available for induction of labour, mechanical method(Foley catheter ) or medical methods( using Prostaglandins). Currently foley catheter is most commonly used mechanical method for labour induction, which acts not only as a mechanical dilator of cervix but also a stimulator of endogenous prostaglandins release from fetal membranes. Oligohydramnios(AFI<5) is one of the most common indication for induction of labour.
The study will be conducted in Women and Children Hospital of JIPMER in the Department of Obstetrics and Gynaecology. Pregnant women with Oligohydramnios at term gestation will be recruited as per the inclusion criteria from the antenatal ward. Informed consent will be obtained from the study subjects before recruitment , in the own language known to study subjects. Detailed history will be obtained from the subject as per the data collection proforma. All participants will be allocated to one of the two groups by Block Randomisation technique using SNOSE method. In the Intervention group, women will be Induced with Transcervical Foley catheter combined with single dose of Dinoprostone Gel. In the Control group , the women will be induced with Transcervical Foley catheter with Extra Amniotic Saline Infusion. For Foley catheter insertion, the patient will asked to lie down on bed in lithotomy position, Foley tube will inserted to cervix through the vagina and the balloon is inflated with saline water. For EASI, the saline will be infused through the Foley catheter at the rate of 100 ml/hr for 6 hours. This helps in separating the membranes and releases Prostaglandins to initiate the process of labour. Foley catheter will left inside for 24 hours if it is not spontaneously expelled. After expulsion of Foley catheter, Bishop score will be assessed. If the cervix is not favourable , further pharmacological agents like PGE1(Misoprostol) or PGE2 ( Dinoprostone gel ), will be used to make cervix favourable. Once the cervix becomes favourable, Oxytocin infusion will be given intravenously to induce Uterine contractions. After starting the process of induction, women will be continuously monitored in the Labour room. Fetal heart rate monitoring will be done. Therefore, in this study we are trying to find out whether Foley catheter combined with Dinoprostone gel will be effective than Foley with EASI for Induction of labour among pregnant women with Oligohydramnios.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant women with Oligohydramnios (AFI less than or equal to 5)at 37 weeks of gestation with single live intrauterine fetus in cephalic presentation.
排除标准
- •1.Uterine scar 2.Foetal anomaly 3.Placental abruption 4.Stage 2 ,3 FGR 5.Severe Pre eclampsia 6.Overt Diabetes/ Uncontrolled Gestational Diabetes mellitus 7.Grand Multipara 8.Contraindication to vaginal delivery 9.Latex allergy / contraindication to Prostaglandins use.
结局指标
主要结局
Proportion of women delivering within 24 hours of induction. Those delivering within 12 hours, beyond 24 hours will also be noted.
时间窗: At term gestation
次要结局
- 1.Changes in Bishop score (Difference between pre induction Bishop & post ripening Bishop)(2.Induction Delivery Interval (IDI), measured as:)
研究者
BSudharshana
JIPMER
