Clinical Trial Results:
A comparison of the effectiveness of prostaglandin gel and tablet preparations in induction of labour at term.
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Summary
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EudraCT number |
2004-003797-28 |
Trial protocol |
GB |
Global end of trial date |
01 Nov 2006
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Results information
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Results version number |
v1(current) |
This version publication date |
30 May 2020
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First version publication date |
30 May 2020
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
EDMK4002
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Additional study identifiers
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ISRCTN number |
ISRCTN70152691 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Imperial College Healthcare NHS Trust
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Sponsor organisation address |
Research Office, Room 221, Medical School Building, St Mary’s, London, United Kingdom, W2 1PG
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Public contact |
Douglas Keith Edmonds, Imperial College Healthcare NHS Trust, k.edmonds@imperial.ac.uk
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Scientific contact |
Douglas Keith Edmonds, Imperial College Healthcare NHS Trust
, k.edmonds@imperial.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Nov 2007
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Nov 2006
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Nov 2006
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine whether Prostaglandin Gel is more effective in term induction of labour than Prostaglandin Tablets. The main outcome measure will be time between the start of the induction process and delivery of the baby.
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Protection of trial subjects |
N/A
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Nov 2004
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 165
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Worldwide total number of subjects |
165
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EEA total number of subjects |
165
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
165
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Women undergoing induction of labour with a cephalic presentation (singleton) or first twin cephalic at term (from ≥36+6 to 42 weeks of gestation) were recruited. | |||||||||
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Pre-assignment
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Screening details |
251 eligible women were approached, of whom 218 (86.8%) provided initial written consent. Of these, 172 (68.52%) were admitted for induction of labour. Following reconfirmation of consent, seven of those 172 (4%) declined. | |||||||||
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Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Prostin E2 gel | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Prostin E2 gel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Gel
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Routes of administration |
Vaginal use
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Dosage and administration details |
The gel contains 1 or 2 mg of dinopristone in 3 grams of thick clear gel in sterile opaque syringes. Prior to the administration of the study drug a fetal cardiogram was performed for 20 minutes. Provided that the fetal heart rate pattern was within normal limits the trial coordinator performed a vaginal examination, recorded the initial Bishop score, and administered gel into the posterior vaginal fornix. The fetal cardiogram was then continued for a further 60 minutes. In patients randomised to receive dinopristone gel, a nulliparous woman with an unfavourable cervix (i.e. with a modified Bishop score ≤ 4) was given an initial dose of 2 mg. Multiparaous women and nulliparous women with a favourable cervix (i.e. with a modified Bishop score of 5–7) were administered an initial dose of 1 mg. Two further vaginal examinations were then performed at intervals of 6 hours, at which a further 1 mg of gel was administered until the cervix became favourable (Bishop score ≥ 8).
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Arm title
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Prostin E2 tablets | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Prostin E2 tablets
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Vaginal use
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Dosage and administration details |
Prior to the administration of the study drug a fetal cardiogram was performed for 20 minutes. Provided that the fetal heart rate pattern was within normal limits the trial coordinator performed a vaginal examination, recorded the initial Bishop score, and administered dinopristone tablets, 3 mg was administered into the posterior vaginal fornix. The fetal cardiogram was then continued for a further 60 minutes. Two further vaginal examinations were then performed at intervals of 6 hours, at which a further 3‐mg tablet was administered until the cervix was favourable (Bishop score ≥ 8).
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial as there was only data available for a certain number of participants. |
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Baseline characteristics reporting groups
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Reporting group title |
Prostin E2 gel
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Prostin E2 tablets
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Prostin E2 gel
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Reporting group description |
- | ||
Reporting group title |
Prostin E2 tablets
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Reporting group description |
- | ||
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End point title |
Median (IQR) interval from induction to delivery (minutes) [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Induction to delivery
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Comparisons between continuous variables by study drug formulation and by parity used the Mann–Whitney U‐test. The Kruskal–Wallis test with Bonferroni correction was used to compare the interval from induction of labour to delivery by Bishop score. Univariate comparisons of dichotomous data were performed with the use of the chi‐square (Fisher’s exact) test. The P values for all hypothesis tests were two‐sided, and P values of 0.05 or less were considered to indicate statistical significance. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Median (IQR) interval from induction to delivery (minutes)-primiparous [2] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Induction to delivery
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Comparisons between continuous variables by study drug formulation and by parity used the Mann–Whitney U‐test. The Kruskal–Wallis test with Bonferroni correction was used to compare the interval from induction of labour to delivery by Bishop score. Univariate comparisons of dichotomous data were performed with the use of the chi‐square (Fisher’s exact) test. The P values for all hypothesis tests were two‐sided, and P values of 0.05 or less were considered to indicate statistical significance. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Median (IQR) interval from induction to delivery (minutes)-multiparous [3] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Induction to delivery
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Comparisons between continuous variables by study drug formulation and by parity used the Mann–Whitney U‐test. The Kruskal–Wallis test with Bonferroni correction was used to compare the interval from induction of labour to delivery by Bishop score. Univariate comparisons of dichotomous data were performed with the use of the chi‐square (Fisher’s exact) test. The P values for all hypothesis tests were two‐sided, and P values of 0.05 or less were considered to indicate statistical significance. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Failed induction [4] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Induction to delivery
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Comparisons between continuous variables by study drug formulation and by parity used the Mann–Whitney U‐test. The Kruskal–Wallis test with Bonferroni correction was used to compare the interval from induction of labour to delivery by Bishop score. Univariate comparisons of dichotomous data were performed with the use of the chi‐square (Fisher’s exact) test. The P values for all hypothesis tests were two‐sided, and P values of 0.05 or less were considered to indicate statistical significance. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Failed induction in primiparous mother [5] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Induction to delivery
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Comparisons between continuous variables by study drug formulation and by parity used the Mann–Whitney U‐test. The Kruskal–Wallis test with Bonferroni correction was used to compare the interval from induction of labour to delivery by Bishop score. Univariate comparisons of dichotomous data were performed with the use of the chi‐square (Fisher’s exact) test. The P values for all hypothesis tests were two‐sided, and P values of 0.05 or less were considered to indicate statistical significance. |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Failed induction in multiparous mother [6] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Induction to delivery
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Comparisons between continuous variables by study drug formulation and by parity used the Mann–Whitney U‐test. The Kruskal–Wallis test with Bonferroni correction was used to compare the interval from induction of labour to delivery by Bishop score. Univariate comparisons of dichotomous data were performed with the use of the chi‐square (Fisher’s exact) test. The P values for all hypothesis tests were two‐sided, and P values of 0.05 or less were considered to indicate statistical significance. |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
During study
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
10
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse events detailed in the publication, https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/j.1471-0528.2011.02901.x, in BJOG and International Journal of Obstetrics and Gynaecology |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/21429067 |
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