Intrapartum Fetal MonitoringNCT04084353
Evaluating a Two Stage Intrapartum Fetal Assessment in India
An observational study of Intrapartum Fetal Monitoring, run by University of Liverpool at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Intrapartum Fetal Monitoring
- What is being tested?
- Intrapartum fetal monitoring training and quality improvement project
- How many people
- 6,682 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2019to 16 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All women that deliver within the obstetrics department in Government Medical College (GMC) during the study period (8 months)
Who may be able to join
- All women that deliver within the obstetrics department in Government Medical College (GMC) during the study period (8 months)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Government Medical College
Nagpur, Maharastra, 440003
About this study
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
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.
Read the 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
- Conditions
- Intrapartum Fetal Monitoring
- Being tested
- Intrapartum fetal monitoring training and quality improvement project
- Keywords
- intra partum fetal monitoring, training, quality improvement, intermittent cardiotocography (CTG), intermittent auscultation, perinatal outcomes, caesarean section rate, obstetric outcomes, India
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrapartum fetal monitoring training and quality improvement projectOther
Intrapartum fetal monitoring training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intrapartum fetal monitoring training and quality improvement project |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean section performed for presumed fetal compromise as a prortion of all caesarean sections
Percentage change of rate per month
Measured: 8 months
Secondary outcomes (19)
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
Measured: 8 months
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
Measured: 8 months
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
Measured: 8 months
Intrapartum fetal monitoring - Cardiotocography (CTG) meetings
Average number of cases discussed per meeting
- Number of cases (CTGs and poor perinatal outcomes) discussed
Measured: 8 months
Training - number of staff trained
Number of staff trained as a percentage of the number of eligible staff. Senior doctors Residents Nurses/midwives Students
Measured: 8 months
Training - Improvement in pre and post test scores
Percentage change between pre and post test scores, per staff member trained
Measured: 8 months
Training - Improvement in self perceived knowledge and confidence about intrapartum fetal monitoring
Mean Likert score
Measured: 8 months
Training - satisfaction and feedback about training
Survey data from staff attending training. Semi-structured questions.
Measured: 8 months
Maternal - Caesarean section rate overall
Number of cases of caesarean section/month as a % of all births
Measured: 8 months
Maternal - Operative vaginal delivery rate
Number of cases of operative delivery/month as a % of all births
Measured: 8 months
Maternal - Maternal length of hospital stay
Average length of maternal stay/per patient/month
Measured: 8 months
Maternal - Maternal death
Total number of maternal deaths/month
Measured: 8 months
Perinatal - Apgar score
Number of cases of Apgar score 7 or below at 5 minutes/month as a percentage of all births
Measured: 8 months
Perinatal - Cord blood lactate
Number of cases of cord blood lactate 4.9 mmol/l or above/month as a percentage of all births
Measured: 8 months
Perinatal - Neonatal resuscitation
Number of babies requiring resuscitation/month as a percentage of all births
Measured: 8 months
Perinatal - Neonatal intensive care unit (NICU) admission
Number of NICU admissions/month as a percentage of all births
Measured: 8 months
Perinatal - Length of NICU stay
Average number of days/admission/month
Measured: 8 months
Perinatal - Neonatal morbidity
Number of cases of birth asphyxia/HIE per month as a percentage of all births
Measured: 8 months
Perinatal - Perinatal death before discharge
Number of perinatal deaths/month as a percentage of all births
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Aug 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrapartum Fetal MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,682 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Government Medical College, Nagpur, Gynuity Health Projects
- Responsible party
- Principal investigator, Andrew D Weeks, University of Liverpool
- Investigators
- Andrew Weeks, Professor, Principal investigator, University of LiverpoolKate Lightly, Dr, Study director, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084353
- Sponsor's protocol ID
- 4835
- Status last verified
- Nov 2020
- First submitted
- 26 Jul 2019
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04084353
- Acronym / sponsor ID
- 4835
- Conditions
- Intrapartum Fetal Monitoring
- Keywords
- intra partum fetal monitoring, training, quality improvement, intermittent cardiotocography (CTG), intermittent auscultation, perinatal outcomes, caesarean section rate, obstetric outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,682 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Government Medical College, Nagpur, Gynuity Health Projects
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delivered women | – | Other: Intrapartum fetal monitoring training and quality improvement projectMaternal 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women that deliver within the obstetrics department in Government Medical College (GMC) during the study period (8 months)
Key inclusion criteria (1 listed)
- All women that deliver within the obstetrics department in Government Medical College (GMC) during the study period (8 months)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrapartum fetal monitoring training and quality improvement projectIntrapartum fetal monitoring training | Other | Delivered women |
Primary outcome
Caesarean section performed for presumed fetal compromise as a prortion of all caesarean sections
Time frame: 8 months
Percentage change of rate per month
19 secondary outcomes
Intrapartum fetal monitoring - Improved documentation
Time frame: 8 months
Intrapartum fetal monitoring - Improved documentation of fetal heart rate
Time frame: 8 months
Intrapartum fetal monitoring - Improved documentation (Risk factors for poor perinatal outcome)
Time frame: 8 months
Intrapartum fetal monitoring - Cardiotocography (CTG) meetings
Time frame: 8 months
Training - number of staff trained
Time frame: 8 months
Training - Improvement in pre and post test scores
Time frame: 8 months
Training - Improvement in self perceived knowledge and confidence about intrapartum fetal monitoring
Time frame: 8 months
Training - satisfaction and feedback about training
Time frame: 8 months
Maternal - Caesarean section rate overall
Time frame: 8 months
Maternal - Operative vaginal delivery rate
Time frame: 8 months
Maternal - Maternal length of hospital stay
Time frame: 8 months
Maternal - Maternal death
Time frame: 8 months
Perinatal - Apgar score
Time frame: 8 months
Perinatal - Cord blood lactate
Time frame: 8 months
Perinatal - Neonatal resuscitation
Time frame: 8 months
Perinatal - Neonatal intensive care unit (NICU) admission
Time frame: 8 months
Perinatal - Length of NICU stay
Time frame: 8 months
Perinatal - Neonatal morbidity
Time frame: 8 months
Perinatal - Perinatal death before discharge
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Weeks, Professor principal investigator
University of Liverpool
Kate Lightly, Dr study director
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrapartum Fetal Monitoring, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caesarean section performed for presumed fetal compromise as a prortion of all caesarean sections (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.