Evaluating a Two Stage Intrapartum Fetal Assessment in India

Intrapartum Fetal Monitoring Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084353
• Other study ID #: 4835
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: March 16, 2020

Study information

• Verified date: November 2020
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6682
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Intrapartum Fetal Monitoring

Intervention

Other:
• Intrapartum fetal monitoring training and quality improvement project
Intrapartum fetal monitoring training

Locations

Country	Name	City	State
United Kingdom	Government Medical College	Nagpur	Maharastra

Sponsors (3)

Lead Sponsor	Collaborator
University of Liverpool	Government Medical College, Nagpur, India, Gynuity Health Projects

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caesarean section performed for presumed fetal compromise as a prortion of all caesarean sections	Percentage change of rate per month	8 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Intrapartum fetal monitoring - Cardiotocography (CTG) meetings	Average number of cases discussed per meeting; • Number of cases (CTGs and poor perinatal outcomes) discussed	8 months
Secondary	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
Secondary	Training - Improvement in pre and post test scores	Percentage change between pre and post test scores, per staff member trained	8 months
Secondary	Training - Improvement in self perceived knowledge and confidence about intrapartum fetal monitoring	Mean Likert score	8 months
Secondary	Training - satisfaction and feedback about training	Survey data from staff attending training. Semi-structured questions.	8 months
Secondary	Maternal - Caesarean section rate overall	Number of cases of caesarean section/month as a % of all births	8 months
Secondary	Maternal - Operative vaginal delivery rate	Number of cases of operative delivery/month as a % of all births	8 months
Secondary	Maternal - Maternal length of hospital stay	Average length of maternal stay/per patient/month	8 months
Secondary	Maternal - Maternal death	Total number of maternal deaths/month	8 months
Secondary	Perinatal - Apgar score	Number of cases of Apgar score 7 or below at 5 minutes/month as a percentage of all births	8 months
Secondary	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
Secondary	Perinatal - Neonatal resuscitation	Number of babies requiring resuscitation/month as a percentage of all births	8 months
Secondary	Perinatal - Neonatal intensive care unit (NICU) admission	Number of NICU admissions/month as a percentage of all births	8 months
Secondary	Perinatal - Length of NICU stay	Average number of days/admission/month	8 months
Secondary	Perinatal - Neonatal morbidity	Number of cases of birth asphyxia/HIE per month as a percentage of all births	8 months
Secondary	Perinatal - Perinatal death before discharge	Number of perinatal deaths/month as a percentage of all births	8 months