Evaluating a Two Stage Intrapartum Fetal Assessment in India

Sponsor

University of Liverpool (Other)

Overall Status

Completed

CT.gov ID

NCT04084353

Collaborator

Government Medical College, Nagpur (Industry), Gynuity Health Projects (Other)

6,682

Enrollment

Location

7.5

Actual Duration (Months)

892

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intrapartum Fetal Monitoring	Other: Intrapartum fetal monitoring training and quality improvement project

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.

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

Study Design

Study Type:

Observational

Actual Enrollment :

6682 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Aug 1, 2019

Actual Primary Completion Date :

Mar 16, 2020

Actual Study Completion Date :

Mar 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Delivered women 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 Intrapartum fetal monitoring training

Arm

Intervention/Treatment

Delivered women

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

Intrapartum fetal monitoring training

Outcome Measures

Primary Outcome Measures

Caesarean section performed for presumed fetal compromise as a prortion of all caesarean sections [8 months]
Percentage change of rate per month

Secondary Outcome Measures

Intrapartum fetal monitoring - Improved documentation [8 months]
Average number of times fetal heart rate (FHR) documented per mother • Number of times fetal heart rate (FHR) documented in labour
Intrapartum fetal monitoring - Improved documentation of fetal heart rate [8 months]
Average 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 months]
Average number of fetal risk factors documented per mother • Risk factors for poor perinatal outcome
Intrapartum fetal monitoring - Cardiotocography (CTG) meetings [8 months]
Average number of cases discussed per meeting • Number of cases (CTGs and poor perinatal outcomes) discussed
Training - number of staff trained [8 months]
Number 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 scores [8 months]
Percentage change between pre and post test scores, per staff member trained
Training - Improvement in self perceived knowledge and confidence about intrapartum fetal monitoring [8 months]
Mean Likert score
Training - satisfaction and feedback about training [8 months]
Survey data from staff attending training. Semi-structured questions.
Maternal - Caesarean section rate overall [8 months]
Number of cases of caesarean section/month as a % of all births
Maternal - Operative vaginal delivery rate [8 months]
Number of cases of operative delivery/month as a % of all births
Maternal - Maternal length of hospital stay [8 months]
Average length of maternal stay/per patient/month
Maternal - Maternal death [8 months]
Total number of maternal deaths/month
Perinatal - Apgar score [8 months]
Number of cases of Apgar score 7 or below at 5 minutes/month as a percentage of all births
Perinatal - Cord blood lactate [8 months]
Number of cases of cord blood lactate 4.9 mmol/l or above/month as a percentage of all births
Perinatal - Neonatal resuscitation [8 months]
Number of babies requiring resuscitation/month as a percentage of all births
Perinatal - Neonatal intensive care unit (NICU) admission [8 months]
Number of NICU admissions/month as a percentage of all births
Perinatal - Length of NICU stay [8 months]
Average number of days/admission/month
Perinatal - Neonatal morbidity [8 months]
Number of cases of birth asphyxia/HIE per month as a percentage of all births
Perinatal - Perinatal death before discharge [8 months]
Number of perinatal deaths/month as a percentage of all births