Feasibility and Acceptability of the Combination of Propess and AN24 Monica for Outpatient Labour Induction (PRAM) (PRAM)
|ClinicalTrials.gov Identifier: NCT01026948|
Recruitment Status : Completed
First Posted : December 7, 2009
Results First Posted : January 6, 2012
Last Update Posted : January 6, 2012
In order to confirm the feasibility of home monitoring with Monica AN 24, a licensed portable device for measuring fetal and maternal electrocardiogram (ECG), and the feasibility of inpatient monitoring with Monica AN 24 in patients with Propess (a vaginal licensed drug delivery system used for induction of labour), we will perform a pilot study that will include 20 women in each arm.
Feasibility of monitoring with Monica AN 24 both in hospital and at home will be confirmed in a pilot study. The success will be defined as at least 10 minutes of continuous satisfactory trace in any given hour in at least 80% of the patient.
A main study will then be conducted to assess the feasibility and acceptability of the Propess and Monica AN24package of care for women undergoing induction of labour.
The research questions are:
- Is outpatient induction with continuous monitoring technically feasible?
- Does the Propess and Monica AN24 care package of care provide adequate clinical information in line with the UK National Institute of Clinical Evidence (NICE) Guideline for Induction of labour?
- Is outpatient induction a concept that appeals to women?
- What do women consider to be the advantages and disadvantages of this package of care?
- What would women consider to be positive and/or negative outcome in future clinical trials of outpatient induction?
- Do fetuses with abnormal electrocardiogram (ECG) patterns have evidence of subclinically impaired cardiac function (feasibility study)?
- Do elevated concentrations of white blood cell components in the umbilical cord blood at birth influence fetal electrocardiogram (feasibility study)?
|Condition or disease||Intervention/treatment|
|Intrapartum Fetal Monitoring Pregnancy||Drug: Dinoprostone Device: Monica AN 24|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||70 participants|
|Official Title:||Feasibility and Acceptability of the Combination of Propess and AN24 Monica for Outpatient Labour Induction (PRAM)|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
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© vaginal delivery system consists of a non-biodegradable polymeric drug delivery device containing 10 mg Dinoprostone (PGE2) 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) in women with intact membranes whereas release is higher and more variable in women with premature rupture of membranes.
Other Name: PropessDevice: Monica AN 24
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.
Other Name: CE0843
- 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. [ Time Frame: 6 months ]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.
- Number of Participants Who Were Satisfied With Monitoring at Home [ Time Frame: 6 months ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026948
|Liverpool Women's NHS Foundation Trust|
|Liverpool, Merseyside, United Kingdom, L8 7SS|
|Principal Investigator:||Zarko Alfirevic, Professor||Liverpool Women's NHS Foundation Trust|