NCT04084353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,682

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

July 26, 2019

Last Update Submit

November 19, 2020

Conditions

Intrapartum Fetal Monitoring

Keywords

intra partum fetal monitoringtrainingquality improvementintermittent cardiotocography (CTG)intermittent auscultationperinatal outcomescaesarean section rateobstetric outcomesIndia

Outcome Measures

Primary Outcomes (1)

  • Caesarean section performed for presumed fetal compromise as a prortion of all caesarean sections

    Percentage change of rate per month

    8 months

Secondary Outcomes (19)

  • Intrapartum fetal monitoring - Improved documentation

    8 months

  • Intrapartum fetal monitoring - Improved documentation of fetal heart rate

    8 months

  • Intrapartum fetal monitoring - Improved documentation (Risk factors for poor perinatal outcome)

    8 months

  • Intrapartum fetal monitoring - Cardiotocography (CTG) meetings

    8 months

  • Training - number of staff trained

    8 months

  • +14 more secondary outcomes

Study Arms (1)

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

Interventions

Intrapartum fetal monitoring training and quality improvement projectOTHER

Intrapartum fetal monitoring training

Delivered women

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen delivered in Government Medical College (GMC) Hospital, Nagpur, India, over two months before, during and two months after project implementation
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All women that deliver within the obstetrics department in Government Medical College (GMC) during the study period (8 months)

You may qualify if:

  • All women that deliver within the obstetrics department in Government Medical College (GMC) during the study period (8 months)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government Medical College

Nagpur, Maharastra, 440003, United Kingdom

Location

Study Officials

  • Andrew Weeks, Professor

    University of Liverpool

    PRINCIPAL INVESTIGATOR

  • Kate Lightly, Dr

    University of Liverpool

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of International Maternal Health

Study Record Dates

First Submitted

July 26, 2019

First Posted

September 10, 2019

Study Start

August 1, 2019

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

November 20, 2020

Record last verified: 2020-11

Locations

GB(1)