What after the first propess?
Research type
Research Study
Full title
What after the first propess. A comparative prospective study
IRAS ID
202984
Contact name
Amr Farag
Contact email
Sponsor organisation
South Warwickshire NHS Foundation Trust
Duration of Study in the UK
0 years, 5 months, 0 days
Research summary
This randomised cohort 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 labour and provided with the study information leaflet.
Inclusion criteria:
• Women booked for induction of labour at 37 to 42 weeks gestation.
• Singleton pregnancy.
• Viable pregnancy.
• Cephalic presentation.
• Intact membranes.
• No previous Caesarean section.
• No fetal concerns.Exclusion criteria:
• Pregnancy less than completed 37 weeks or more than 42 weeks.
• Multiple pregnancy.
• Intrauterine fetal death.
• Non-cephalic presentation.
• Pre-labour ruptured membranes
• Previous one or more Caesarean sections.
• Antenatal concerns regarding fetal wellbeing.
• Non-reassuring or abnormal CTG on admission to labour ward.When attending for induction of labour on delivery suite, an informed consent will be obtained then all women will have a 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 labour 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 labour.
• If a senior obstetrician decides not to remove the first pessary after 24 hours.
• If woman withdraws her consent to continue as a part of the study.After 24 hours from insertion of the first Dinoprostone pessary, women will be reassessed and women with unachievable artificial rupture of membranes will be randomly assigned to one of three intervention groups by a pre-formed computer-generated random list and randomisation put in sealed opaque envelopes kept in a locked secure area on delivery suite.
Intervention groups will be as follows:Group 1:
The women will have no intervention for 24 hours following removal of initial slow-release Dinoprostone pessary, apart from pain relief as required, followed by reassessment and insertion of a second slow-release pessary if required 24 hours after removal of the first one.Group 2:
The women will have 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 and will be left for 6 hours followed by reassessment and insertion of a second tablet if still ARM is not achievable.Group 3:
The women will have insertion of 1-4 hygroscopic cervical dilators (Dilapan-S® Aquacryl hydrogel rod; HPSRx Enterprises, USA) by a senior obstetrician into the cervical canal, immediately after removal of the slow-release pessary and left for 18-24 hours.For all participants, after achieving spontaneous or artificial rupture of membranes, the local protocol for intrapartum care will be followed and after delivery, the women will be asked to fill in a patient's satisfaction questionnaire about the process of induction, care given and being a part of the study.
Data collection forms will be inserted in each study envelope where primary and secondary outcomes will be recorded.
Statistical methods:
Data will be tabulated then statistically analyzed using SPSS version 15. Multiple regression analysis will be used to analyse several variables among different groups. Parametric variables will presented as mean ± SD, numeric non-parametric variables will be presented as median and interquartile range while categorical variables will presented as number and percentage (%). Chi-squared test will be used for comparison between groups with regard to qualitative variables. Student’s t-test will be used for comparison between groups for numeric parametric variables, while Mann–Whitney U-test will be used for numeric non-parametric variables. Associations between measured variables will be assessed using Pearson’s correlation coefficient (for metric variables) and Spearman’s correlation coefficient (for rank variables).REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
16/WM/0268
Date of REC Opinion
5 Sep 2016
REC opinion
Further Information Favourable Opinion