Clinical trial NCT04084353: Evaluating a Two Stage Intrapartum Fetal Assessment in India
Official title: 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: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Government Medical College, Nagpur
name: Gynuity Health Projects
First posted: 2019-09-10
Enrollment: 6682
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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

Eligibility criteria: 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

Primary outcomes:
measure: Caesarean section performed for presumed fetal compromise as a prortion of all caesarean sections
timeFrame: 8 months
Secondary outcomes:
measure: Intrapartum fetal monitoring - Improved documentation
timeFrame: 8 months
measure: Intrapartum fetal monitoring - Improved documentation of fetal heart rate
timeFrame: 8 months
measure: Intrapartum fetal monitoring - Improved documentation (Risk factors for poor perinatal outcome)
timeFrame: 8 months
measure: Intrapartum fetal monitoring - Cardiotocography (CTG) meetings
timeFrame: 8 months
measure: Training - number of staff trained
timeFrame: 8 months
measure: Training - Improvement in pre and post test scores
timeFrame: 8 months
measure: Training - Improvement in self perceived knowledge and confidence about intrapartum fetal monitoring
timeFrame: 8 months
measure: Training - satisfaction and feedback about training
timeFrame: 8 months
measure: Maternal - Caesarean section rate overall
timeFrame: 8 months
measure: Maternal - Operative vaginal delivery rate
timeFrame: 8 months
measure: Maternal - Maternal length of hospital stay
timeFrame: 8 months
measure: Maternal - Maternal death
timeFrame: 8 months
measure: Perinatal - Apgar score
timeFrame: 8 months
measure: Perinatal - Cord blood lactate
timeFrame: 8 months
measure: Perinatal - Neonatal resuscitation
timeFrame: 8 months
measure: Perinatal - Neonatal intensive care unit (NICU) admission
timeFrame: 8 months
measure: Perinatal - Length of NICU stay
timeFrame: 8 months
measure: Perinatal - Neonatal morbidity
timeFrame: 8 months
measure: Perinatal - Perinatal death before discharge
timeFrame: 8 months
Other outcomes:
Locations:
city: Nagpur
country: United Kingdom
facility: Government Medical College
state: Maharastra
Study officials:
affiliation: University of Liverpool
name: Andrew Weeks, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Liverpool
name: Kate Lightly, Dr
role: STUDY_DIRECTOR
References: