Feasibility and Acceptability of the Combination of Propess and AN24 Monica for Outpatient Labour Induction (PRAM) - Full Text View

Purpose

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	Intervention	Phase
Intrapartum Fetal Monitoring Pregnancy	Drug: Dinoprostone Device: Monica AN 24	Phase 4

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Feasibility and Acceptability of the Combination of Propess and AN24 Monica for Outpatient Labour Induction (PRAM)

Resource links provided by NLM:

Drug Information available for: Dinoprostone

U.S. FDA Resources

Further study details as provided by Liverpool Women's NHS Foundation Trust:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Number of Participants Who Were Satisfied With Monitoring at Home [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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

Enrollment:	70
Study Start Date:	January 2009
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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	Drug: Dinoprostone 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: Propess Device: 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

Groups/Cohorts

Assigned Interventions

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

Drug: Dinoprostone

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: Propess

Device: 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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

In Liverpool Women's Hospital, women who have completed 37 weeks of Pregnancy and require induction of labour (as per inclusion/exclusion criteria above) while attending Antenatal clinic, delivery suite or the Obstetric Assessment Unit are offered management options. Women who have normal cardiotocogram(CTG), normal amniotic fluid volume and cephalic presentation confirmed by ultrasound, and who decide to have induction of labour were recruited.

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:
1. Social inductions/maternal requests
2. Induction of labour for symphysis pubic dysfunction
3. Obstetric Cholestasis
4. 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026948

Locations

United Kingdom
Liverpool Women's NHS Foundation Trust
Liverpool, Merseyside, United Kingdom, L8 7SS

Sponsors and Collaborators

Liverpool Women's NHS Foundation Trust

University of Liverpool

Investigators

Principal Investigator:

Zarko Alfirevic, Professor

Liverpool Women's NHS Foundation Trust

More Information

No publications provided

Responsible Party:	Liverpool Women's NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT01026948 History of Changes
Other Study ID Numbers:	LWH0764
Study First Received:	December 3, 2009
Results First Received:	June 22, 2011
Last Updated:	January 4, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Liverpool Women's NHS Foundation Trust:

Induction of labour
Intraprtum fetal monitoring

Additional relevant MeSH terms:

Dinoprostone
Oxytocics
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013