Evaluating a Two Stage Intrapartum Fetal Assessment in India

Overview

An intrapartum fetal monitoring training programme (on intermittent auscultation and cardiotocography) will be delivered at Government Medical College (GMC) to all relevant staff. This quality improvement project and training evaluation aims to assess and evaluate the impact of this training. This will allow the investigators to understand if it is feasible and acceptable to staff, increases knowledge and improves patient outcomes.

Full Title of Study: “Evaluating the Impact of Introducing a Two Stage Intrapartum Fetal Monitoring Assessment Using Intermittent Auscultation and Cardiotocography in a Government Hospital, Nagpur, India”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2020

Detailed Description

As part of Misoprostol or Oxytocin for Labour Induction (MOLI) randomised controlled trial (RCT) (CTRI no. NCT03749902), Government Medical College (GMC) plans to increase the number of cardiotocography (CTG) machines available on labour ward and provide a United Kingdom (UK) based obstetrician to deliver training on cardiotocography (CTG) interpretation in order to improve fetal monitoring for this high risk population.

An intrapartum fetal monitoring training programme (on intermittent auscultation and cardiotocography) will be delivered at Government Medical College (GMC) to all relevant staff. This quality improvement project and training evaluation aims to assess and evaluate the impact of this training. This will allow the investigators to understand if it is feasible and acceptable to staff, increases knowledge and improves patient outcomes. It will be done through staff questionnaires, pre-and-post test scores and by examining the effects on maternal and perinatal outcomes using Kirkpatrick's training evaluation.

The whole project aims:

- To understand current practice and maternal and perinatal outcomes in Government Medical College (GMC)

- To improve intrapartum fetal monitoring with intermittent auscultation and cardiotocography (CTG)

- To improve perinatal morbidity and mortality rates

- To reduce caesarean section rates for presumed fetal compromise

Interventions

  • Other: Intrapartum fetal monitoring training and quality improvement project
    • Intrapartum fetal monitoring training

Arms, Groups and Cohorts

  • Delivered women
    • Maternal and perinatal outcomes will be collected prospectively on all patients that deliver in Government Medical College (GMC) Hospital before, during and after the training over the study period (8 months) in order to evaluate the impact of the training.

Clinical Trial Outcome Measures

Primary Measures

  • Caesarean section performed for presumed fetal compromise as a prortion of all caesarean sections
    • Time Frame: 8 months
    • Percentage change of rate per month

Secondary Measures

  • Intrapartum fetal monitoring – Improved documentation
    • Time Frame: 8 months
    • Average number of times fetal heart rate (FHR) documented per mother • Number of times fetal heart rate (FHR) documented in labour
  • Intrapartum fetal monitoring – Improved documentation of fetal heart rate
    • Time Frame: 8 months
    • Average time between last FHR documented and delivery (minutes) • Average time between last fetal heart rate (FHR) documented and delivery
  • Intrapartum fetal monitoring – Improved documentation (Risk factors for poor perinatal outcome)
    • Time Frame: 8 months
    • Average number of fetal risk factors documented per mother • Risk factors for poor perinatal outcome
  • Intrapartum fetal monitoring – Cardiotocography (CTG) meetings
    • Time Frame: 8 months
    • Average number of cases discussed per meeting • Number of cases (CTGs and poor perinatal outcomes) discussed
  • Training – number of staff trained
    • Time Frame: 8 months
    • Number of staff trained as a percentage of the number of eligible staff. Senior doctors Residents Nurses/midwives Students
  • Training – Improvement in pre and post test scores
    • Time Frame: 8 months
    • Percentage change between pre and post test scores, per staff member trained
  • Training – Improvement in self perceived knowledge and confidence about intrapartum fetal monitoring
    • Time Frame: 8 months
    • Mean Likert score
  • Training – satisfaction and feedback about training
    • Time Frame: 8 months
    • Survey data from staff attending training. Semi-structured questions.
  • Maternal – Caesarean section rate overall
    • Time Frame: 8 months
    • Number of cases of caesarean section/month as a % of all births
  • Maternal – Operative vaginal delivery rate
    • Time Frame: 8 months
    • Number of cases of operative delivery/month as a % of all births
  • Maternal – Maternal length of hospital stay
    • Time Frame: 8 months
    • Average length of maternal stay/per patient/month
  • Maternal – Maternal death
    • Time Frame: 8 months
    • Total number of maternal deaths/month
  • Perinatal – Apgar score
    • Time Frame: 8 months
    • Number of cases of Apgar score 7 or below at 5 minutes/month as a percentage of all births
  • Perinatal – Cord blood lactate
    • Time Frame: 8 months
    • Number of cases of cord blood lactate 4.9 mmol/l or above/month as a percentage of all births
  • Perinatal – Neonatal resuscitation
    • Time Frame: 8 months
    • Number of babies requiring resuscitation/month as a percentage of all births
  • Perinatal – Neonatal intensive care unit (NICU) admission
    • Time Frame: 8 months
    • Number of NICU admissions/month as a percentage of all births
  • Perinatal – Length of NICU stay
    • Time Frame: 8 months
    • Average number of days/admission/month
  • Perinatal – Neonatal morbidity
    • Time Frame: 8 months
    • Number of cases of birth asphyxia/HIE per month as a percentage of all births
  • Perinatal – Perinatal death before discharge
    • Time Frame: 8 months
    • Number of perinatal deaths/month as a percentage of all births

Participating in This Clinical Trial

Inclusion Criteria

  • All women that deliver within the obstetrics department in Government Medical College (GMC) during the study period (8 months)

Exclusion Criteria

  • Deliveries in A&E/medical wards
  • Home deliveries
  • Patients delivered in other hospitals/ambulance deliveries
  • Macerated still birth
  • Fresh still birth with no fetal heart on admission to hospital

Gender Eligibility: Female

Women delivered in Government Medical College (GMC) Hospital, Nagpur, India, over two months before, during and two months after project implementation

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Liverpool
  • Collaborator
    • Government Medical College, Nagpur, India
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andrew Weeks MD MRCOG, Professor of International Maternal Health – University of Liverpool
  • Overall Official(s)
    • Andrew Weeks, Professor, Principal Investigator, University of Liverpool
    • Kate Lightly, Dr, Study Director, University of Liverpool
  • Overall Contact(s)
    • Kate Lightly, Dr, +44-7875642837, klightly@liverpool.ac.uk

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