N/A
N=70
Feasibility and Acceptability of the Combination of Propess and AN24 Monica for Outpatient Labour Induction (PRAM)
Intrapartum Fetal Monitoring · Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT01026948 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: 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. — 62 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Dinoprostone (Drug); Monica AN 24 (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Liverpool Women's NHS Foundation Trust
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
62 | — |
| SECONDARY Number of Participants Who Were Satisfied With Monitoring at Home |
46 | — |
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)?
Eligibility Criteria
Inclusion criteria
Women with singleton pregnancy and cephalic presentation booked for induction of labour with unfavourable cervix (Bishop score <6) and normal pre-induction fetal monitoring.
Low risk women in the context of this study include:
- Uncomplicated pregnancy requiring induction of labour after completed 37 weeks of of pregnancy with normal fetal assessment including:
- Social inductions/maternal requests
- Induction of labour for symphysis pubic dysfunction
- Obstetric Cholestasis
- Nonspecific Proteinuria (without any other medical problems)
- Parity < 4
- Intact membranes at study entry
- Living within a reasonable distance from the hospital (i.e., not more than approximately 60 minutes driving time)
- Caregiver present at all times while at home
- Easy access to a safe method of transport for return to hospital
- Easy access to a telephone (either land line or mobile with good service)
- Agrees to remove the pessary herself following instructions in the patient leaflet
- Written informed consent
Exclusion criteria
- Previous caesarean section
- Abnormal preinduction cardiotocogram (CTG)
- Multiple pregnancy
- Fetal malformation or chromosomal abnormality
- Maternal age less than 18 years
- Contraindication to Propess induction
- Breech Presentation
- Foetal growth restriction
- Hypertension
- All Diabetics
Data sourced from ClinicalTrials.gov (NCT01026948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.