Evaluating a Two Stage Intrapartum Fetal Assessment in India

November 19, 2020 updated by: Andrew D Weeks, University of Liverpool

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6682

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Maharastra
      • Nagpur, Maharastra, United Kingdom, 440003
        • Government Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Caesarean section performed for presumed fetal compromise as a prortion of all caesarean sections
Time Frame: 8 months
Percentage change of rate per month
8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
8 months
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
8 months
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
8 months
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
8 months
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
8 months
Training - Improvement in pre and post test scores
Time Frame: 8 months
Percentage change between pre and post test scores, per staff member trained
8 months
Training - Improvement in self perceived knowledge and confidence about intrapartum fetal monitoring
Time Frame: 8 months
Mean Likert score
8 months
Training - satisfaction and feedback about training
Time Frame: 8 months
Survey data from staff attending training. Semi-structured questions.
8 months
Maternal - Caesarean section rate overall
Time Frame: 8 months
Number of cases of caesarean section/month as a % of all births
8 months
Maternal - Operative vaginal delivery rate
Time Frame: 8 months
Number of cases of operative delivery/month as a % of all births
8 months
Maternal - Maternal length of hospital stay
Time Frame: 8 months
Average length of maternal stay/per patient/month
8 months
Maternal - Maternal death
Time Frame: 8 months
Total number of maternal deaths/month
8 months
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
8 months
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
8 months
Perinatal - Neonatal resuscitation
Time Frame: 8 months
Number of babies requiring resuscitation/month as a percentage of all births
8 months
Perinatal - Neonatal intensive care unit (NICU) admission
Time Frame: 8 months
Number of NICU admissions/month as a percentage of all births
8 months
Perinatal - Length of NICU stay
Time Frame: 8 months
Average number of days/admission/month
8 months
Perinatal - Neonatal morbidity
Time Frame: 8 months
Number of cases of birth asphyxia/HIE per month as a percentage of all births
8 months
Perinatal - Perinatal death before discharge
Time Frame: 8 months
Number of perinatal deaths/month as a percentage of all births
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Liverpool

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gynuity Health Projects
Government Medical College, Nagpur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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