Evaluating a Two Stage Intrapartum Fetal Assessment in India

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Intrapartum Fetal Monitoring

Intervention / Treatment
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* Other: Intrapartum fetal monitoring training and quality improvement project


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Delivered women<br>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<br>* Intrapartum fetal monitoring training<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intra partum fetal monitoring, training, quality improvement, intermittent cardiotocography (CTG), intermittent auscultation, perinatal outcomes, caesarean section rate, obstetric outcomes, India