Feasibility Study Protocol of a Pragmatic, Randomised Controlled Pilot Trial: Membrane Sweeping to Prevent Post-term Pregnancy: The MILO Study
试验速览
- 阶段
- 不适用
- 入组人数
- 132
- 主要终点
- Adherence with the trial interventions.
研究概览
简要总结
Multicentre, pragmatic, parallel group, pilot randomised controlled trial with an embedded factorial design.
详细描述
The primary aim of the MILO study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. We will also assess the acceptability and feasibility of the proposed trial interventions to clinicians and women (through focus group interviews).
Methods/Design
Multicentre, pragmatic, parallel group, pilot randomised controlled trial with an embedded factorial design. Pregnant women with a live, singleton fetus ≥ 38 weeks gestation, cephalic presentation, longitudinal lie, intact membranes, English speaking and ≥18 years of age will be randomised in a 2:1 ratio to:
• Membrane sweep versus no membrane sweep
Women allocated randomly to a sweep will then be randomised further (factorial component) to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinicians performing a membrane sweep cannot be blinded and it is not feasible to genuinely blind membrane sweeping for women. Therefore, neither clinicians administering the intervention nor women will be blinded to group assignment. Data will be reviewed by two assessors blinded to group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women carrying a live singleton fetus ≥ 38 weeks completed gestation.
- •(Gestational age will be calculated from the first day of the last menstrual period and an
- •ultrasound examination carried out in the 2nd trimester)
- •Longitudinal lie
- •Cephalic presentation
- •Intact amniotic
- •≥ 18 years of age on enrollment
排除标准
- •Not able to communicate in english
- •contraindications to a vaginal examination
- •contraindications to a vaginal birth
研究组 & 干预措施
Group A
Membrane sweep @ 39 weeks' gestation only
干预措施: Amniotic membrane sweep (Procedure)
Group B
Membrane sweep @ 40 weeks' gestation only
干预措施: Amniotic membrane sweep (Procedure)
Group C
Membrane sweep @ 39, 40 and 41 weeks' gestation or until onset of labour
干预措施: Amniotic membrane sweep (Procedure)
Group D
Membrane sweep @ 40 and 41 weeks' gestation or until onset of labour
干预措施: Amniotic membrane sweep (Procedure)
Control Group
Women in the control arm will not receive a membrane sweep and will receive usual care (as defined by local hospital protocols and vaginal examination to determine Bishop score only).
结局指标
主要结局
Adherence with the trial interventions.
时间窗: At month 15 approximately
Evaluation of adherence with the trial interventions, and reasons for non-compliance assessed by study-specific checklists. Data will be extracted from routinely collected data and focus group interviews with clinicians and participants at six weeks post intervention.
Evaluation of the data collection process through study specific checklists
时间窗: At month 21 approximately
Evaluated, statistically and narratively, by assessing the completeness of outcome measurements at baseline and postnatal (6 weeks) through study specific checklists. Researchers will manually examine the data collected. They will assess the proportion of complete data collection forms, the quality of data collected and the applicability of this data in facilitating pilot trial outcomes.
Evaluation of the data analysis process
时间窗: At month 21 approximately
As this is a feasibility study formal hypothesis testing will not be undertaken. Researchers will manually examine the data collected. Evaluation of the data analysis process will be undertaken through the assessment of gaps and limitations to the analysis process measured by study-specific checklist. Findings will be reported through descriptive statistics and graphical summaries.
Feasibility of the cost effectiveness analyses
时间窗: At month 21 approximately
Assessment of the mechanism and utilisation of the incremental cost-effectiveness ratio (ICER), through study specific checklists.
Evaluation of attrition rates
时间窗: At month 15 approximately
Evaluation of attrition rates assessed by study-specific checklists. Data will be extracted from routinely collected data.
Evaluation of the types of attrition
时间窗: At month 21 approximately
Evaluation of the types of attrition assessed by case report forms. Data will be extracted from routinely collected data.
Feasibility of cost analyses process through analysis of study specific documentation.
时间窗: At month 21 approximately
Assessment of data collection tools to undertake cost effectiveness analysis through study specific documentation. Researchers will manually examine data to assess the mechanism of, timing of and delivery of the cost analysis tools.
Evaluation of the EQ5D
时间窗: At month 21 approximately
Assessment of the mechanism of, timing of and delivery of the EQ5D through study specific checklists.
Recruitment
时间窗: Duration of the recruitment process (approximately 8 months )
Evaluation of the number and percentage of eligible women who are recruited and randomised to the study. Assessed by study-specific checklists.
Retention
时间窗: At month 15 approximately
Evaluation of the number and percentage of eligible women who are randomised, take part in and adhere to the study protocols. Data will be extracted from routinely collected data.
Evaluation of the randomisation process.
时间窗: At month 15 approximately
Evaluation of effective allocation of participants to the intervention/control group assessed by study-specific checklists and evaluation of the randomisation protocol throughout the randomisation period.
Estimate the main effect of individual intervention components and their interactions
时间窗: At month 21 approximately
Estimates (with measures of uncertainty) of the main effect of individual intervention components and any interaction effect between the main effects of the embedded factorial design will be assessed and reported using regression analysis.
次要结局
- Uterine rupture(From time of randomisation to birth of baby (up to 5 weeks))
- Number of participants achieving a spontaneous vaginal birth(From time of randomisation to birth of baby (up to 5 weeks))
- Caesarean Section(From time of randomisation to birth of baby (up to 5 weeks))
- Uterine hyperstimulation with/without fetal heart rate (FHR) changes(From time of randomisation to birth of baby (up to 5 weeks))
- Admission to neonatal intensive care unit or equivalent(From time of birth to six weeks postnatal.)
- Length of time from membrane sweep to birth of baby.(From time of membrane sweep to birth of baby (up to 4 weeks))
- Number of participants who underwent an induction of labour(From time of randomisation to commencement of formal induction of labour (up to 5 weeks).)
- Epidural analgesia(From time of randomisation to birth of baby (up to 5 weeks))
- Perinatal death(From time of randomisation to seven completed days after birth of baby (up to 6 weeks))
- Neonatal encephalopathy(From time of birth to six weeks postnatal.)
- Length of time from formal induction of labour to birth of baby.(From time of formal induction of labour to birth of baby (up to 2 weeks))
- Post-Partum Haemorrhage ≥ 500mls(From time of birth to 24 hours after the birth of baby.)
- Antepartum haemorrhage requiring hospital admission(From 24+0 weeks of pregnancy to birth of baby (up to 18 weeks))
- Augmentation of labour(From commencement of established labour to birth of baby (up to 2 days))
- Pyrexia in labour(From commencement of established labour to birth of baby (up to 2 days))
- Number of participants achieving a spontaneous onset of labour(From time of randomisation to commencement of spontaneous onset of labour or formal induction of labour or caesarean section (up to 5 weeks))
- Instrumental birth(From time of randomisation to birth of baby (up to 5 weeks))
- Serious maternal death or morbidity(From time of randomisation to six weeks postnatal (up to 11 weeks).)
- EQ5D-5L(From time of randomisation to six weeks postnatal (up to 11 weeks))
- Serious neonatal morbidity(From time of birth of baby to six weeks postnatal.)
- Apgar score < 7 at five minutes.(From birth of baby to five minutes of life.)
- Cord PH < 7.20(From birth of infant to collection of cord bloods after delivery of the placenta (an average of 15 minutes))
- Length of infant stay in neonatal intensive care unit or equivalent(From time of birth to six weeks postnatal.)
- Overall length of maternal hospital stay(From time of randomisation to six weeks postnatal (up to 11 weeks).)
研究者
Prof. Declan Devane
Scientific Director, HRB-Trials Methodology Research Network
National University of Ireland, Galway, Ireland