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

NCT01026948 | Completed Results

• 1 other identifier: LWH0764
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is outpatient induction with continuous monitoring technically feasible?
2. 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. 3.Is outpatient induction a concept that appeals to women?
4. 4.What do women consider to be the advantages and disadvantages of this package of care?
5. 5.What would women consider to be positive and/or negative outcome in future clinical trials of outpatient induction?
6. 6.Do fetuses with abnormal electrocardiogram (ECG) patterns have evidence of subclinically impaired cardiac function (feasibility study)?
7. 7.Do elevated concentrations of white blood cell components in the umbilical cord blood at birth influence fetal electrocardiogram (feasibility study)?

Conditions

Intrapartum Fetal Monitoring; Pregnancy

Keywords

Induction of labour; Intraprtum fetal monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  6 months

Secondary Outcomes (1)

• Number of Participants Who Were Satisfied With Monitoring at Home

  6 months

Study Arms (1)

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; Device: Monica AN 24

Interventions

Dinoprostone DRUG

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.

Also known as: Propess

Propess and Monica AN24 care package

Monica AN 24 DEVICE

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.

Also known as: CE0843

Propess and Monica AN24 care package

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool Women's NHS Foundation Trust: lead
• University of Liverpool: collaborator

Study Sites (1)

Liverpool Women's NHS Foundation Trust

Liverpool, Merseyside, L8 7SS, United Kingdom

Location

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Professor Zarko Alfirevic
• Organization: University of Liverpool

zarko@liverpool.ac.uk

00 44(1)51 702

Study Officials

• Zarko Alfirevic, Professor

  Liverpool Women's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 7, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 6, 2012
• Results First Posted: January 6, 2012

Record last verified: 2011-11

Locations

GB (1)