Evaluating a Two Stage Intrapartum Fetal Assessment in India

Evaluating the Impact of Introducing a Two Stage Intrapartum Fetal Monitoring Assessment Using Intermittent Auscultation and Cardiotocography in a Government Hospital, Nagpur, India

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.

Study Overview

• Status: Completed
• Conditions: Intrapartum Fetal Monitoring
• Intervention / Treatment: Other: Intrapartum fetal monitoring training and quality improvement project

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

• Study Type: Observational
• Enrollment (Actual): 6682

Contacts and Locations

Study Locations

• United Kingdom
  • Maharastra
    • Nagpur, Maharastra, United Kingdom, 440003
      • Government Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Intrapartum fetal monitoring training and quality improvement project; Intrapartum fetal monitoring training

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Liverpool
• Collaborators: Gynuity Health Projects; Government Medical College, Nagpur

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ACTUAL): March 16, 2020
• Study Completion (ACTUAL): March 16, 2020

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (ACTUAL): September 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: training; India; quality improvement; perinatal outcomes; intra partum fetal monitoring; intermittent cardiotocography (CTG); intermittent auscultation; caesarean section rate; obstetric outcomes
• Other Study ID Numbers: 4835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No