Use of wind-up fetal Doppler versus Pinard for fetal heart rate intermittent monitoring in labour: A randomised clinical trial

BMJ Open, Volume 5, No. 1, Year 2015

Interprétation

Objectives: In resource-poor settings, the standard of care to inform labour management is the partograph plus Pinard stethoscope for intermittent fetal heart rate (FHR) monitoring. We compared FHR monitoring in labour using a novel, robust wind-up handheld Doppler with the Pinard as a primary screening tool for abnormal FHR on perinatal outcomes. Design: Prospective equally randomised clinical trial. Setting: The labour and delivery unit of a teaching hospital in Kampala, Uganda. Participants: Of the 2042 eligible antenatal women, 1971 women in active term labour, following uncomplicated pregnancies, were randomised to either the standard of care or not. Intervention: Intermittent FHR monitoring using Doppler. Primary outcome measures: Incidence of FHR abnormality detection, intrapartum stillbirth and neonatal mortality prior to discharge. Results: Age, parity, gestational age, mode of delivery and newborn weight were similar between study groups. In the Doppler group, there was a significantly higher rate of FHR abnormalities detected (incidence rate ratio (IRR)=1.61, 95% CI 1.13 to 2.30). However, in this group, there were also higher though not statistically significant rates of intrapartum stillbirths (IRR=3.94, 0.44 to 35.24) and neonatal deaths (IRR=1.38, 0.44 to 4.34). Conclusions: Routine monitoring with a handheld Doppler increased the identification of FHR abnormalities in labour; however, our trial did not find evidence that this leads to a decrease in the incidence of intrapartum stillbirth or neonatal death. We undertook this randomised controlled trial at St. Raphael of St. Francis Nsambya Hospital, a periurban private not-for-profit hospital in Kampala, Uganda. It is a teaching hospital that manages 7500 deliveries annually. CTG and fetal blood gas sampling to support labour management, and epidural pain medication are not available. Oxytocin augmentation and caesarean delivery rates are 40% and 20%, respectively. The standard of care for intrapartum FHR monitoring is by intermittent auscultation using the Pinard. Women were requested to participate during an antenatal care appointment. This consent was reconfirmed in labour provided the women presented in labour with a singleton pregnancy, in a cephalic position, at term or post-term (>37 weeks gestation). Women were excluded if they were already in second stage of labour on admission or presented with a condition that, according to the doctor on duty, contraindicated labouring (eg, antepartum haemorrhage); if there was a diagnosis of intrauterine fetal death on admission; or if the woman was admitted for an elective caesarean delivery. Participants were presented with information about the study and agreeing participants provided written consent. Registration of our protocol with ClinicalTrials.gov occurred before participant enrolment started, but due to an administrative error with our institution’s Clinical Research Services Unit, the protocol was only released to the public after the completion of the study. Documentation from the Chair of our independent Research Ethics Board was provided to BMJ Open attesting to the version of the protocol provided to them prior to the start of enrolment. Women were equally randomised to one of the two study methods using sequentially numbered, opaque sealed envelopes. Study participants and care providers were not blinded to the intervention. Data were collected from the patient’s partograph and from the hospital’s routine neonatal mortality audit data, when applicable. The standard of care for intrapartum monitoring relied on partograph and FHR monitoring with the Pinard. Our prestudy training addresses deficiencies in monitoring standards (acceptable range for FHR, recognition of accelerations, decelerations and change in baseline). We developed a training module entitled ‘Helping Babies Survive Labour’ modelling on the ‘Helping Babies Breathe’ visual materials and learning approach. The technical basis was from WHO and Canadian Obstetric Society protocols.5 All midwives and doctors were then given this in-service training for half a day. FHR monitoring was undertaken every 30 min in the first stage of labour; every 15 min in the second stage before pushing; and every 5 min in the second stage when pushing and for 1 min immediately after a contraction. The baseline FHR was recorded as a single number rather than a range, in the unit of bpm. The FHR rhythm (regular or irregular) and absence or presence of accelerations or decelerations were also documented. The maternal radial pulse was simultaneously palpated to differentiate it from the FHR. When FHR abnormalities were identified, the standard of care would be to switch from intermittent auscultation to CTG. Since CTG is not available in Nsambya Hospital, any noted FHR abnormalities were reported by the research midwife to the doctor on duty for assessment. Management following this assessment was either closer intermittent monitoring or intrauterine resuscitation with reassessment of the FHR. Intrauterine resuscitation consisted of maternal position change, administration of oxygen by mask to the mother-to-be, initiation of intravenous infusion, discontinuation of oxytocin augmentation and consideration of prompt delivery (assisted vaginal if imminent, otherwise by caesarean). The primary outcome measures of interest were detection of FHR abnormality in labour (defined below), intrapartum stillbirth and neonatal deaths in the first 24 h of life. FHR abnormality is defined as tachycardia, bradycardia, or atypical variable, late or prolonged decelerations. Tachycardia and bradycardia are defined as baselines of >160 and <110 bpm, respectively. Some features of atypical variable decelerations are abrupt FHR decelerations, lasting >2 min, slow return to baseline, or in the presence of tachycardia. Late decelerations are a repetitive, gradual decrease in the FHR and return to baseline, starting after the onset of the contraction, and return to baseline after the end of the contraction. Prolonged decelerations are a decrease from baseline of >15 bpm lasting for 2–10 min. Secondary outcomes were Apgar score less than 7 at 5 min, admission to special care unit for intrapartum-related complications (intrapartum hypoxia, neonatal encephalopathy (NE) or meconium aspiration syndrome), diagnosis of NE and delivery by caesarean. A validated and simplified scoring method was used for grading mild, moderate and severe NE.15 16 Indications for caesarean delivery were failure to progress (as indicated by crossing of the action line on the partograph), abnormal FHR unresponsive to uterine resuscitation and identification of malpresentation in labour (eg, conversion from vertex to brow or mentum posterior). Estimating that the use of the Doppler would reduce intrapartum stillbirth by 30% compared with the Pinard (based on the results of Mahomed et al14), with 80% power to detect at least a 30% reduction in stillbirths with 95% confidence, we would need to enrol 840 participants in each of the two comparison groups. We added 20% to the sample size for each study arm to account for loss to follow-up and statistical adjustments and stratification, resulting in 1008 participants required for each comparison group. Data were double entered from the partograph and, where applicable, the hospital’s routine neonatal mortality audit document. An interim analysis was conducted by the data safety and monitoring board at the midpoint of the data collection period. Descriptive statistics were used to describe the characteristics of the participants and their outcomes under each study arm. We used population-averaged generalised Poisson regression modelling with robust variance to compare methods of FHR monitoring with Doppler versus Pinard on incidence rate ratio (IRR) of detection of FHR abnormalities, intrapartum stillbirth and neonatal mortality (see Barros and Hirakata17 for details of this choice over logistic regression). We conducted a subgroup analysis and qualitative reporting on the intrapartum stillbirths and pre-discharge neonatal deaths within 24 h and those fetuses with detected abnormal FHR. All analyses were conducted using Stata/SE (StataCorp, 2011. Stata Statistical Software: Release V.12. College Station, Texas, USA: StataCorp LP). The sponsor had no role in designing the study, analysing data, collecting data, interpreting the results, writing the report or in the decision to submit the paper for publication. The corresponding author had complete access to all the data.

Résumé de l’IA

Study Justification:

This study aimed to compare the use of a wind-up handheld Doppler with the Pinard stethoscope for fetal heart rate (FHR) monitoring in labor. The standard of care in resource-poor settings is the Pinard stethoscope, but the wind-up Doppler offers a novel and robust alternative. The study aimed to determine if the Doppler could improve the detection of FHR abnormalities and potentially reduce the incidence of intrapartum stillbirth and neonatal death.

Highlights:

– The study compared FHR monitoring using a wind-up Doppler with the standard Pinard stethoscope in labor.
– The Doppler group had a higher rate of FHR abnormalities detected compared to the Pinard group.
– However, there were no statistically significant differences in the rates of intrapartum stillbirth or neonatal death between the two groups.
– The study was conducted at a teaching hospital in Kampala, Uganda, with a large number of annual deliveries.
– The standard of care for FHR monitoring in the hospital was intermittent auscultation using the Pinard stethoscope.
– The study participants were randomly assigned to either the Doppler or Pinard group.
– Data were collected from the patient’s partograph and routine neonatal mortality audit data.

Recommendations:

Based on the study findings, the following recommendations can be made:

1. Consider incorporating the wind-up Doppler as an additional tool for FHR monitoring in labor.
2. Provide training to healthcare providers on the proper use of the wind-up Doppler.
3. Conduct further research to explore the potential benefits of the wind-up Doppler in reducing intrapartum stillbirth and neonatal death.

Key Role Players:

To address the recommendations, the following key role players may be needed:

1. Healthcare providers: Midwives and doctors who will use the wind-up Doppler for FHR monitoring.
2. Training facilitators: Experts who can provide training on the use of the wind-up Doppler.
3. Hospital administrators: Responsible for implementing changes in FHR monitoring protocols and providing necessary resources.

Cost Items for Planning:

While the actual cost may vary, the following cost items should be considered in planning the recommendations:

1. Procurement of wind-up Dopplers: The cost of purchasing the wind-up Dopplers for use in the labor and delivery unit.
2. Training costs: Expenses related to organizing and conducting training sessions for healthcare providers.
3. Monitoring and evaluation: Budget for monitoring and evaluating the implementation of the wind-up Doppler in clinical practice.
4. Research funding: If further research is recommended, budget for conducting additional studies to explore the benefits of the wind-up Doppler.
Please note that the provided cost items are estimates and may vary depending on the specific context and requirements of the implementation.

Force de la preuve

The strength of evidence for this abstract is 7 out of 10.
The evidence in the abstract is based on a randomised clinical trial, which is a strong study design. However, the sample size is relatively small, which may limit the generalizability of the findings. To improve the evidence, a larger sample size could be used in future studies. Additionally, blinding the participants and care providers to the intervention could reduce bias. Finally, conducting a longer follow-up period to assess neonatal outcomes beyond the first 24 hours would provide more comprehensive results.

Abstrait

We undertook this randomised controlled trial at St. Raphael of St. Francis Nsambya Hospital, a periurban private not-for-profit hospital in Kampala, Uganda. It is a teaching hospital that manages 7500 deliveries annually. CTG and fetal blood gas sampling to support labour management, and epidural pain medication are not available. Oxytocin augmentation and caesarean delivery rates are 40% and 20%, respectively. The standard of care for intrapartum FHR monitoring is by intermittent auscultation using the Pinard. Women were requested to participate during an antenatal care appointment. This consent was reconfirmed in labour provided the women presented in labour with a singleton pregnancy, in a cephalic position, at term or post-term (>37 weeks gestation). Women were excluded if they were already in second stage of labour on admission or presented with a condition that, according to the doctor on duty, contraindicated labouring (eg, antepartum haemorrhage); if there was a diagnosis of intrauterine fetal death on admission; or if the woman was admitted for an elective caesarean delivery. Participants were presented with information about the study and agreeing participants provided written consent. Registration of our protocol with ClinicalTrials.gov occurred before participant enrolment started, but due to an administrative error with our institution’s Clinical Research Services Unit, the protocol was only released to the public after the completion of the study. Documentation from the Chair of our independent Research Ethics Board was provided to BMJ Open attesting to the version of the protocol provided to them prior to the start of enrolment. Women were equally randomised to one of the two study methods using sequentially numbered, opaque sealed envelopes. Study participants and care providers were not blinded to the intervention. Data were collected from the patient’s partograph and from the hospital’s routine neonatal mortality audit data, when applicable. The standard of care for intrapartum monitoring relied on partograph and FHR monitoring with the Pinard. Our prestudy training addresses deficiencies in monitoring standards (acceptable range for FHR, recognition of accelerations, decelerations and change in baseline). We developed a training module entitled ‘Helping Babies Survive Labour’ modelling on the ‘Helping Babies Breathe’ visual materials and learning approach. The technical basis was from WHO and Canadian Obstetric Society protocols.5 All midwives and doctors were then given this in-service training for half a day. FHR monitoring was undertaken every 30 min in the first stage of labour; every 15 min in the second stage before pushing; and every 5 min in the second stage when pushing and for 1 min immediately after a contraction. The baseline FHR was recorded as a single number rather than a range, in the unit of bpm. The FHR rhythm (regular or irregular) and absence or presence of accelerations or decelerations were also documented. The maternal radial pulse was simultaneously palpated to differentiate it from the FHR. When FHR abnormalities were identified, the standard of care would be to switch from intermittent auscultation to CTG. Since CTG is not available in Nsambya Hospital, any noted FHR abnormalities were reported by the research midwife to the doctor on duty for assessment. Management following this assessment was either closer intermittent monitoring or intrauterine resuscitation with reassessment of the FHR. Intrauterine resuscitation consisted of maternal position change, administration of oxygen by mask to the mother-to-be, initiation of intravenous infusion, discontinuation of oxytocin augmentation and consideration of prompt delivery (assisted vaginal if imminent, otherwise by caesarean). The primary outcome measures of interest were detection of FHR abnormality in labour (defined below), intrapartum stillbirth and neonatal deaths in the first 24 h of life. FHR abnormality is defined as tachycardia, bradycardia, or atypical variable, late or prolonged decelerations. Tachycardia and bradycardia are defined as baselines of >160 and 2 min, slow return to baseline, or in the presence of tachycardia. Late decelerations are a repetitive, gradual decrease in the FHR and return to baseline, starting after the onset of the contraction, and return to baseline after the end of the contraction. Prolonged decelerations are a decrease from baseline of >15 bpm lasting for 2–10 min. Secondary outcomes were Apgar score less than 7 at 5 min, admission to special care unit for intrapartum-related complications (intrapartum hypoxia, neonatal encephalopathy (NE) or meconium aspiration syndrome), diagnosis of NE and delivery by caesarean. A validated and simplified scoring method was used for grading mild, moderate and severe NE.15 16 Indications for caesarean delivery were failure to progress (as indicated by crossing of the action line on the partograph), abnormal FHR unresponsive to uterine resuscitation and identification of malpresentation in labour (eg, conversion from vertex to brow or mentum posterior). Estimating that the use of the Doppler would reduce intrapartum stillbirth by 30% compared with the Pinard (based on the results of Mahomed et al14), with 80% power to detect at least a 30% reduction in stillbirths with 95% confidence, we would need to enrol 840 participants in each of the two comparison groups. We added 20% to the sample size for each study arm to account for loss to follow-up and statistical adjustments and stratification, resulting in 1008 participants required for each comparison group. Data were double entered from the partograph and, where applicable, the hospital’s routine neonatal mortality audit document. An interim analysis was conducted by the data safety and monitoring board at the midpoint of the data collection period. Descriptive statistics were used to describe the characteristics of the participants and their outcomes under each study arm. We used population-averaged generalised Poisson regression modelling with robust variance to compare methods of FHR monitoring with Doppler versus Pinard on incidence rate ratio (IRR) of detection of FHR abnormalities, intrapartum stillbirth and neonatal mortality (see Barros and Hirakata17 for details of this choice over logistic regression). We conducted a subgroup analysis and qualitative reporting on the intrapartum stillbirths and pre-discharge neonatal deaths within 24 h and those fetuses with detected abnormal FHR. All analyses were conducted using Stata/SE (StataCorp, 2011. Stata Statistical Software: Release V.12. College Station, Texas, USA: StataCorp LP). The sponsor had no role in designing the study, analysing data, collecting data, interpreting the results, writing the report or in the decision to submit the paper for publication. The corresponding author had complete access to all the data.

Matériaux

Innovations

Based on the provided information, one potential innovation to improve access to maternal health is the use of a wind-up handheld Doppler for fetal heart rate (FHR) monitoring in labor. This innovation was compared to the standard of care, which involves using a Pinard stethoscope for intermittent FHR monitoring. The study found that the wind-up Doppler increased the identification of FHR abnormalities in labor. However, the trial did not find evidence that this led to a decrease in the incidence of intrapartum stillbirth or neonatal death.

AI Innovations Description

The recommendation based on the study is to consider using a wind-up handheld Doppler for fetal heart rate (FHR) monitoring in labor as a potential innovation to improve access to maternal health. The study compared FHR monitoring using the wind-up Doppler with the standard of care, which is intermittent FHR monitoring using the Pinard stethoscope.

The study found that the use of the wind-up Doppler increased the detection of FHR abnormalities in labor compared to the Pinard. However, the study did not find evidence that this led to a decrease in the incidence of intrapartum stillbirth or neonatal death.

It is important to note that the study was conducted in a resource-poor setting, specifically at a teaching hospital in Kampala, Uganda. The hospital manages 7500 deliveries annually and does not have access to CTG and fetal blood gas sampling for labor management. The standard of care for FHR monitoring in this setting is intermittent auscultation using the Pinard.

The study participants were antenatal women in active term labor with uncomplicated pregnancies. They were randomly assigned to either the standard of care or the wind-up Doppler group. Data were collected from the patient’s partograph and the hospital’s routine neonatal mortality audit data.

The study suggests that using the wind-up Doppler for FHR monitoring in labor may increase the detection of FHR abnormalities. However, further research is needed to determine if this innovation can lead to improved maternal and neonatal outcomes, such as a decrease in intrapartum stillbirth and neonatal death rates.

Implementing the use of wind-up handheld Doppler for FHR monitoring in labor could potentially improve access to maternal health in resource-poor settings where advanced monitoring technologies like CTG are not available. However, it is important to carefully consider the potential benefits and risks of this innovation and conduct further research to evaluate its effectiveness and safety.

AI Innovations Methodology

Based on the provided information, the study compared the use of a wind-up handheld Doppler with the Pinard stethoscope for fetal heart rate (FHR) monitoring in labor. The objective was to determine if the Doppler could improve the detection of FHR abnormalities and subsequently reduce the incidence of intrapartum stillbirth and neonatal mortality.

To simulate the impact of these recommendations on improving access to maternal health, a methodology could be developed as follows:

1. Define the target population: Identify the specific population that would benefit from improved access to maternal health, such as women in resource-poor settings or low-income communities.

2. Identify the barriers to access: Determine the existing barriers that prevent women from accessing adequate maternal health services, such as limited availability of healthcare facilities, lack of trained healthcare providers, or financial constraints.

3. Assess the potential impact of the recommendations: Analyze the potential impact of using wind-up handheld Doppler for FHR monitoring compared to the standard Pinard stethoscope. This could involve reviewing existing literature, conducting surveys or interviews with healthcare providers and patients, and analyzing data from similar studies.

4. Develop a simulation model: Create a simulation model that incorporates the identified barriers to access and the potential impact of the recommendations. This model should consider factors such as the number of women in need of maternal health services, the availability of healthcare facilities and providers, the cost of implementing the recommendations, and the potential reduction in intrapartum stillbirth and neonatal mortality.

5. Run the simulation: Use the developed simulation model to simulate different scenarios and assess the impact of implementing the recommendations. This could involve varying parameters such as the number of healthcare facilities, the availability of trained providers, and the cost of implementing the Doppler technology. The simulation should provide estimates of the potential improvements in access to maternal health and the associated reduction in adverse outcomes.

6. Evaluate the results: Analyze the results of the simulation to determine the potential benefits and challenges of implementing the recommendations. Consider factors such as cost-effectiveness, scalability, and sustainability of the proposed innovation. This evaluation will help inform decision-making and prioritize interventions to improve access to maternal health.

It is important to note that the methodology described above is a general framework and may need to be adapted based on the specific context and available data. Additionally, involving relevant stakeholders, such as healthcare providers, policymakers, and community members, in the simulation process can provide valuable insights and ensure the relevance and feasibility of the recommendations.

Auteur

Dima Health

Statistics:

Citations: 23

Identifiers:

DOI: 10.1136/bmjopen-2014-006867

Research Areas:

Community Interventions, Health System and Policy, Maternal Access, Maternal and Child Health, Quality of Care, Sexual and Reproductive Health, Social Determinants, Workforce

Study Countries:

Uganda

Study Design:

Cohort Study, Cross Sectional Study, Grounded Theory, Quasi Experimental Study, randomised-control-trial

Study Approach:

Mixed-methods, Qualitative, Quantitative

Participants Gender:

Female

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