What After the First Propess. A Randomised Comparative Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Rate of achieving spontaneous or artificial rupture of membranes
研究概览
简要总结
The aim of this study is to compare three different regimens for continuation of induction of labor after no spontaneous or artificial rupture of membranes could be achieved after first 24 hours post-insertion of Dinoprostone
详细描述
This randomized study will be carried out at delivery suite in Warwick Hospital after eligible women have been informed of the study when booked for induction of labor and provided with the study information leaflet
When attending for induction of labor on delivery suite, an informed consent will be obtained then all women will have a cardiotocogram (CTG) performed initially and will be assessed by vaginal examination and Bishop score recorded at insertion of first slow-release pessary (Propess®10 mg Dinoprostone; CTS, UK), which will be inserted high into the posterior vaginal fornix. Assessment and insertion of pessary will be done by an experienced obstetrician or a senior midwife
All women will be given the required care and support as per the local protocols and guidelines
Women will be excluded from the study within the first 24 hours of induction of labor in the following conditions:
- Women with abnormal or non-reassuring CTG needing intervention.
- Women needing tocolytic use.
- Women needing removal of the Dinoprostone pessary.
- Women needing emergency Caesarean section.
- If spontaneous rupture of membranes occurs.
- If artificial rupture of membranes is achievable after the first 24 hours of induction of labor (Bishop score 5 or more)
- If woman withdraws her consent to continue as a part of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women booked for induction of labor at 37 to 42 weeks gestation
- •Viable singleton pregnancy.
- •Cephalic presentation.
- •Intact membranes.
- •No previous Caesarean section.
- •No antenatal fetal concerns (Fetal growth restriction (FGR), small for gestational age (SGA), impaired Doppler, oligohydramnios, non-reassuring/abnormal CTG).
排除标准
- •Pregnancy less than completed 37 weeks or more than 42 weeks.
- •Multiple pregnancy.
- •Intrauterine fetal death.
- •Non-cephalic presentation.
- •Pre-labor rupture of membranes
- •Previous one or more Caesarean sections.
- •Antenatal concerns regarding fetal well-being (FGR, SGA, impaired Doppler, oligohydramnios, non-reassuring/abnormal CTG).
- •Non-reassuring or abnormal CTG on admission to labor ward
研究组 & 干预措施
Extension of propess+/-second propess
Women will have the initial slow-release Dinoprostone pessary left in place for six more hours (total of 30 hours in place) then removed followed by vaginal assessment 48 hours after the start of labour induction and insertion of a second slow-release pessary if required
干预措施: 10 mg Dinoprostone; CTS, UK (Drug)
Prostin
Women will have the initial slow-release Dinoprostone pessary removed followed by insertion of quick-release Dinoprostone tablet (Prostin® 3 mg Dinoprostone vaginal tablet; Pfizer, UK) high in the posterior vaginal fornix immediately after removal of the slow-release pessary. The tablet will be left for 6 hours followed by vaginal reassessment and insertion of a second tablet if ARM is still not achievable.
干预措施: 3 mg Dinoprostone vaginal tablet; Pfizer, UK (Drug)
Dilapan-S
Women will have the initial slow-release Dinoprostone pessary removed followed by insertion of 1-5 Osmotic cervical rods (Dilapan-S® Aquacryl hydrogel rod; HPSRx Enterprises, USA) by a senior obstetrician or a midwife into the cervical canal, immediately after removal of the slow-release pessary using a vaginal speculum and a holder. The rods will be left for 12-24 hours.
干预措施: Aquacryl hydrogel rod; HPSRx Enterprises, USA (Drug)
结局指标
主要结局
Rate of achieving spontaneous or artificial rupture of membranes
时间窗: 12 months
percentage of women who will have spontaneous or artificial rupture of membranes
次要结局
- Time interval needed from start of induction of labor to achieve spontaneous or artificial rupture of membranes(12 months)
- Rate of hyperstimulation (contractions more than 5 in 10 minutes or each contraction lasting more than 90 seconds)(12 months)
- Rate of abnormal CTG changes needing intervention(12 months)
- Rate of need for tocolysis(12 months)
- Rate of emergency Caesarean section(12 months)
- Grades of Caesarean sections(12 months)
- Women's satisfaction with the method of induction used(12 months)
研究者
Amr Farag
Consultant Obstetrician and Gynaecologist
Walsall Healthcare NHS Trust