Trial Outcomes & Findings for Feasibility and Acceptability of the Combination of Propess and AN24 Monica for Outpatient Labour Induction (PRAM) (NCT NCT01026948)
NCT ID: NCT01026948
Last Updated: 2012-01-06
Results Overview
Outpatient induction is when women recieve medication to induce labour at the hospital, but can then go home for monitoring until labour progresses. When 'standard' Doppler Ultrasound FHR technology is used, women may feel restrained as the Doppler-FHR machine (which is bench-top device) is connected to the transducer which is then mounted on the woman's abdomen and attached by an elastic belt, which is known to be uncomfortable for pregnant woman. The AN 24 device is portable and attaches to the patients abdomen allowing remote fetal monitoring whilst the women are at home.
COMPLETED
70 participants
6 months
2012-01-06
Participant Flow
Participant milestones
| Measure |
Propess and Monica AN24 Care Package
Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.
Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.
AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment.
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|---|---|
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Overall Study
STARTED
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70
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Overall Study
COMPLETED
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62
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Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
| Measure |
Propess and Monica AN24 Care Package
Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.
Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.
AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment.
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|---|---|
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Overall Study
Physician Decision
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8
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Baseline Characteristics
Feasibility and Acceptability of the Combination of Propess and AN24 Monica for Outpatient Labour Induction (PRAM)
Baseline characteristics by cohort
| Measure |
Propess and Monica AN24 Care Package
n=70 Participants
Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.
Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.
AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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70 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
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70 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Region of Enrollment
United Kingdom
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70 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 monthsPopulation: 70 women were recruited to the study, but 8 women were called back to the unit because of signal loss.
Outpatient induction is when women recieve medication to induce labour at the hospital, but can then go home for monitoring until labour progresses. When 'standard' Doppler Ultrasound FHR technology is used, women may feel restrained as the Doppler-FHR machine (which is bench-top device) is connected to the transducer which is then mounted on the woman's abdomen and attached by an elastic belt, which is known to be uncomfortable for pregnant woman. The AN 24 device is portable and attaches to the patients abdomen allowing remote fetal monitoring whilst the women are at home.
Outcome measures
| Measure |
Propess and Monica AN24 Care Package
n=62 Participants
Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.
Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.
AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment.
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Feasibility Defined as the Number of Eligible Women Who Are Successfully Monitored Remotely With Trans-abdominal Fetal Electrocardiogram (ECG) Monitoring Device (Monica AN24) While Undergoing Labour Induction.
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62 participants
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SECONDARY outcome
Timeframe: 6 monthsPopulation: 51 women out 70 returned the semistructured diaries. All the diaries were assessed as explained above.
Maternal views were assessed by semi-structured diaries,recording women's ratings on a 4 point scale (very satisfied, satisfied, slightly disatisfied, very disatisfied)of how well they were coping and their satisfaction with outpatient experience.Women completed diaries at least once every two hours at home.Mean scores were calculated for women's ratings of coping, comfort satisfaction and location preference. An interpretive approach was utilised for all open responses. Comments made in the free-text spaces of diaries were categorised to contextualise women's ratings of their experience
Outcome measures
| Measure |
Propess and Monica AN24 Care Package
n=51 Participants
Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.
Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.
AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment.
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Number of Participants Who Were Satisfied With Monitoring at Home
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46 participants
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Adverse Events
Propess and Monica AN24 Care Package
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place