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Evaluating a Two Stage Intrapartum Fetal Assessment in India

NCT ID: NCT04084353

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6682 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-03-16

Brief Summary

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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

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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

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Intrapartum Fetal Monitoring

Keywords

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intra partum fetal monitoring training quality improvement intermittent cardiotocography (CTG) intermittent auscultation perinatal outcomes caesarean section rate obstetric outcomes India

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Intrapartum fetal monitoring training and quality improvement project

Intervention Type OTHER

Intrapartum fetal monitoring training

Interventions

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Intrapartum fetal monitoring training and quality improvement project

Intrapartum fetal monitoring training

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Government Medical College, Nagpur

INDUSTRY

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role collaborator

University of Liverpool

OTHER

Sponsor Role lead

Responsible Party

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Andrew D Weeks

Professor of International Maternal Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Weeks, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Kate Lightly, Dr

Role: STUDY_DIRECTOR

University of Liverpool

Locations

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Government Medical College

Nagpur, Maharastra, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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4835

Identifier Type: -

Identifier Source: org_study_id