Feasibility and Acceptability of the Combination of Propess and AN24 Monica for Outpatient Labour Induction (PRAM)
Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
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:
1. Is outpatient induction with continuous monitoring technically feasible?
2. 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?
3. Is outpatient induction a concept that appeals to women?
4. What do women consider to be the advantages and disadvantages of this package of care?
5. What would women consider to be positive and/or negative outcome in future clinical
trials of outpatient induction?
6. Do fetuses with abnormal electrocardiogram (ECG) patterns have evidence of subclinically
impaired cardiac function (feasibility study)?
7. Do elevated concentrations of white blood cell components in the umbilical cord blood at
birth influence fetal electrocardiogram (feasibility study)?