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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04084353
Enrollment
6682
Registered
2019-09-10
Start date
2019-08-01
Completion date
2020-03-16
Last updated
2020-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrapartum Fetal Monitoring

Keywords

intra partum fetal monitoring, training, quality improvement, intermittent cardiotocography (CTG), intermittent auscultation, perinatal outcomes, caesarean section rate, obstetric outcomes, India

Brief summary

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

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

OTHERIntrapartum fetal monitoring training and quality improvement project

Intrapartum fetal monitoring training

Sponsors

Government Medical College, Nagpur
CollaboratorINDUSTRY
Gynuity Health Projects
CollaboratorOTHER
University of Liverpool
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Caesarean section performed for presumed fetal compromise as a prortion of all caesarean sections8 monthsPercentage change of rate per month

Secondary

MeasureTime frameDescription
Intrapartum fetal monitoring - Improved documentation of fetal heart rate8 monthsAverage 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)8 monthsAverage number of fetal risk factors documented per mother • Risk factors for poor perinatal outcome
Intrapartum fetal monitoring - Cardiotocography (CTG) meetings8 monthsAverage number of cases discussed per meeting • Number of cases (CTGs and poor perinatal outcomes) discussed
Training - number of staff trained8 monthsNumber 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 scores8 monthsPercentage change between pre and post test scores, per staff member trained
Training - Improvement in self perceived knowledge and confidence about intrapartum fetal monitoring8 monthsMean Likert score
Training - satisfaction and feedback about training8 monthsSurvey data from staff attending training. Semi-structured questions.
Maternal - Caesarean section rate overall8 monthsNumber of cases of caesarean section/month as a % of all births
Maternal - Operative vaginal delivery rate8 monthsNumber of cases of operative delivery/month as a % of all births
Intrapartum fetal monitoring - Improved documentation8 monthsAverage number of times fetal heart rate (FHR) documented per mother • Number of times fetal heart rate (FHR) documented in labour
Maternal - Maternal death8 monthsTotal number of maternal deaths/month
Perinatal - Apgar score8 monthsNumber of cases of Apgar score 7 or below at 5 minutes/month as a percentage of all births
Perinatal - Cord blood lactate8 monthsNumber of cases of cord blood lactate 4.9 mmol/l or above/month as a percentage of all births
Perinatal - Neonatal resuscitation8 monthsNumber of babies requiring resuscitation/month as a percentage of all births
Perinatal - Neonatal intensive care unit (NICU) admission8 monthsNumber of NICU admissions/month as a percentage of all births
Perinatal - Length of NICU stay8 monthsAverage number of days/admission/month
Perinatal - Neonatal morbidity8 monthsNumber of cases of birth asphyxia/HIE per month as a percentage of all births
Perinatal - Perinatal death before discharge8 monthsNumber of perinatal deaths/month as a percentage of all births
Maternal - Maternal length of hospital stay8 monthsAverage length of maternal stay/per patient/month

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026