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Completed

NCT Number: NCT04084353

Evaluating a Two Stage Intrapartum Fetal Assessment in 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.

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Key information

Conditions

Intrapartum Fetal Monitoring

Sex eligibility

Female

Study type

Observational

Primary location

Government Medical College

Nagpur, Maharastra, 440003, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrapartum fetal monitoring training and quality improvement project

Other

Intrapartum fetal monitoring training

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Training - Improvement in pre and post test scores

    Time frame: 8 months

    Percentage change between pre and post test scores, per staff member trained

  7. Training - Improvement in self perceived knowledge and confidence about intrapartum fetal monitoring

    Time frame: 8 months

    Mean Likert score

  8. Training - satisfaction and feedback about training

    Time frame: 8 months

    Survey data from staff attending training. Semi-structured questions.

  9. Maternal - Caesarean section rate overall

    Time frame: 8 months

    Number of cases of caesarean section/month as a % of all births

  10. Maternal - Operative vaginal delivery rate

    Time frame: 8 months

    Number of cases of operative delivery/month as a % of all births

  11. Maternal - Maternal length of hospital stay

    Time frame: 8 months

    Average length of maternal stay/per patient/month

  12. Maternal - Maternal death

    Time frame: 8 months

    Total number of maternal deaths/month

  13. 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

  14. 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

  15. Perinatal - Neonatal resuscitation

    Time frame: 8 months

    Number of babies requiring resuscitation/month as a percentage of all births

  16. Perinatal - Neonatal intensive care unit (NICU) admission

    Time frame: 8 months

    Number of NICU admissions/month as a percentage of all births

  17. Perinatal - Length of NICU stay

    Time frame: 8 months

    Average number of days/admission/month

  18. Perinatal - Neonatal morbidity

    Time frame: 8 months

    Number of cases of birth asphyxia/HIE per month as a percentage of all births

  19. Perinatal - Perinatal death before discharge

    Time frame: 8 months

    Number of perinatal deaths/month as a percentage of all births

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

  • Government Medical College, Nagpur
  • Gynuity Health Projects

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2019
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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