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Regímenes de vigilancia fetal para mejorar los resultados de salud en fetos presuntamente grandes para la edad gestacional

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Resumen

Antecedentes

Las políticas y los protocolos varían mucho para la vigilancia fetal en un embarazo donde el feto tiene un tamaño presuntamente grande para la edad gestacional (TGEG). Todos al final terminan en decisiones acerca de la forma y el momento del parto. Se sabe que el TGEG se asocia con mayores riesgos para la madre y el feto. Las intervenciones basadas en los resultados del régimen de vigilancia se pueden asociar con riesgos para la madre y el feto.

Objetivos

Evaluar la efectividad o la eficacia de diferentes métodos de vigilancia prenatal en fetos presuntamente grandes para la edad gestacional sobre resultados importantes de salud para la madre y el feto.

Métodos de búsqueda

Se hicieron búsquedas en el registro de ensayos del Grupo Cochrane de Embarazo y Parto (Cochrane Pregnancy and Childbirth Group) (30 de agosto 2015), ClinicalTrials.gov y la WHO International Clinical Trials Registry Platform (ICTRP) (21 de agosto 2015).

Criterios de selección

Ensayos cuasialeatorizados y aleatorizados grupales publicados y no publicados que compararon los efectos de regímenes prenatales descritos de vigilancia fetal en pacientes con fetos presuntamente grandes para la edad gestacional.

Obtención y análisis de los datos

No se identificaron estudios que cumplieran con los criterios de inclusión de esta revisión.

Resultados principales

No se incluyeron ensayos.

Conclusiones de los autores

No se encontraron ensayos controlados aleatorizados que evaluaran el efecto de los regímenes prenatales de vigilancia fetal de un presunto feto con TGEG sobre resultados importantes de salud para la madre y el feto.

Durante las últimas décadas ha habido un incremento de la prevalencia de fetos con TGEG en muchos países. Por lo tanto, se requieren estudios de investigación sobre los regímenes de vigilancia prenatal de los presuntos fetos con TGEG para guiar la práctica y mejorar los resultados de salud para la madre y el feto. En concreto, serían útiles los ensayos controlados aleatorizados que investiguen si las evaluaciones prenatales seriadas en el consultorio y la evaluación ecográfica de los presuntos fetos con TGEG (que incluyen el volumen del líquido y los marcadores de adiposidad fetal) y evalúen si los métodos de vigilancia mejoran los resultados de salud. Además, como existe preocupación con respecto a que la identificación de los presuntos fetos con TGEG puede provocar ansiedad materna, investigaciones e intervenciones innecesarias, dichos ensayos necesitarían evaluar los riesgos, así como los efectos beneficiosos de los regímenes de vigilancia fetal para los presuntos fetos con TGEG.

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Resumen en términos sencillos

Uso de diferentes métodos para detectar si un feto tiene un tamaño grande para la edad gestacional, para mejorar los resultados de salud

¿Cuál es el problema?

En ocasiones, el feto puede crecer hasta ser más grande de lo esperado y nacer con un peso alto. Cuando se sospecha un crecimiento excesivo del feto durante el embarazo, la madre puede tener visitas prenatales y pruebas programadas adicionales para evaluar su salud y la salud del feto en desarrollo.

¿Por qué es esto importante?

Las pruebas pueden detectar si hay signos de deterioro en la condición del feto o si se han desarrollado complicaciones en la madre. Las combinaciones de pruebas y la frecuencia especificada varían con las políticas y los protocolos locales. Las pruebas pueden incluir recuento de los movimientos fetales, evaluación de la frecuencia cardíaca fetal (cardiotocografía), comprobación de la glucosa sanguínea de la madre o el uso de ecografía para exámenes del crecimiento fetal, revisión con ecografía Doppler de los vasos sanguíneos fetales y evaluación del volumen de líquido alrededor del feto.

Los fetos grandes se asocian con mayores riesgos para ellos y para la madre, que incluyen mayor riesgo de muerte intrauterina y mortinatalidad. Al parto, el recién nacido tiene un riesgo mayor de presentar niveles bajos de oxígeno, distocia de hombro, lesiones nerviosas, fractura ósea, niveles bajos de glucosa en sangre e ingreso a la unidad de cuidados intensivos neonatales. Las complicaciones maternas incluyen trabajo de parto prolongado, partos operatorios que incluyen cesárea, traumatismo perineal, hemorragia posparto y rotura uterina.

Las intervenciones que pueden enlentecer la aceleración del crecimiento y mejorar los resultados de salud para la madre y el feto incluyen asesoramiento dietético, modificación del estilo de vida y, en las pacientes con diabetes o diabetes gestacional, la monitorización de la glucemia y el tratamiento con insulina.

¿Qué evidencia se encontró?

El 10 de agosto 2015 se buscaron estudios pero no se encontraron ensayos controlados aleatorizados que consideraran los efectos de realizar pruebas adicionales sobre los resultados de salud en las pacientes embarazadas con un crecimiento excesivo del feto después de las 20 semanas de gestación.

¿Qué significa esto?

Se necesitan ensayos controlados aleatorios en esta área para informar la práctica clínica cuando se identifican fetos grandes durante un embarazo, para evaluar si las pruebas o la vigilancia adicionales pueden mejorar la salud de estas embarazadas y sus fetos. También es importante identificar cualquier efecto perjudicial asociado con las pruebas y la vigilancia adicional, ya que la identificación de las embarazadas con presuntos fetos grandes puede provocar ansiedad materna innecesaria con investigaciones e intervenciones adicionales, que incluyen la inducción del trabajo de parto o la cesárea.

Authors' conclusions

Implications for practice

There is no evidence from randomised controlled trials to evaluate regimens of fetal surveillance for suspected large‐for‐gestational‐age (LGA) fetuses to improve health outcomes.

Implications for research

The absence of randomised controlled trials relating to regimens of fetal surveillance for suspected LGA fetuses to improve health outcomes reveals an area where research is needed.

There has been a rise in the prevalence of LGA babies over the past few decades in many countries (Aye 2010; Lahmann 2009), so research is required on regimens of antenatal surveillance of suspected LGA infants in order to improve the health outcomes for the mother and infant. In particular, randomised control trials to investigate if serial antenatal clinic and ultrasound assessment of suspected LGA infants (including liquor volume and markers of fetal adiposity) would be useful to assess if surveillance methods improve health outcomes. In addition, as there are concerns that identifying suspected LGA fetuses may lead to unnecessary maternal anxiety, investigations and interventions, any such trial would need to assess the risks as well as benefits of regimens of fetal surveillance for suspected LGA fetuses.

Background

Description of the condition

Large‐for‐gestational‐age (LGA) is used to describe fetuses or infants with a suspected disturbance of growth, where actual or estimated growth is more than expected for gestational age (Xu 2010).

There are various definitions used to describe growth of the baby during pregnancy. LGA is usually defined as an estimated fetal weight more than the 90th percentile (Pundir 2009). Macrosomia, a frequently‐used term, refers to growth beyond a specific threshold, usually defined as birthweight of 4000 g or more (Delpapa 1991), although some studies have suggested grading macrosomia depending on birthweight, into grade one (4000 to 4499 g), grade two (4500 to 4999 g) and grade three (5000 g or more) (Boulet 2003).

There is a wide variation in the prevalence of macrosomia in different countries. Amongst European countries, prevalence of grade one macrosomia varies between 8% and 21% (Bergmann 2003; Gyselaers 2012; Orland 2012). Macrosomia prevalence in Asian countries tends to be much lower, at 1% to 8% (Li 2014; Morikawa 2013). The worldwide prevalence of grade one macrosomia is approximately 9% and the prevalence of grade three macrosomia is approximately 0.1% (Chauhan 2005).

LGA is associated with a number of maternal or fetal factors. The majority of cases of LGA infants are associated with maternal factors including maternal height, weight, body mass index (BMI), gestational weight gain, ethnicity, parity and maternal age (Bergmann 2003; Stotland 2004), as well as the presence of pre‐gestational or gestational diabetes (Ehrenberg 2004). Fetal factors contributing to LGA infants include fetal sex, post‐term birth, uncertain dates and, less commonly, fetal genetic abnormalities (Vora 2009).

LGA is known to be associated with increased risks to both the mother and baby. Fetal and neonatal implications include increased risk of intra‐uterine death and stillbirth, fetal hypoxia, shoulder dystocia, brachial plexus injuries, bone fracture, hypoglycaemia, and admission to the neonatal intensive care unit (Esakoff 2009; Ju 2009). Maternal complications include prolonged labour, operative births including caesarean section, perineal trauma, postpartum haemorrhage and uterine rupture (Ju 2009; King 2012; Stotland 2004).

It can be difficult to differentiate accurately between a constitutionally LGA infant, due to maternal height, weight and ethnicity, and an infant with abnormally elevated growth for gestation.

Description of the intervention

Management of suspected LGA fetuses requires several steps. Initially, those infants at risk of LGA are identified either by clinical assessment, maternal estimation, or knowledge of risk factors such as diabetes. Once a fetus is suspected of being LGA, further assessment to assist in the diagnosis is performed, such as an ultrasound scan. Following this, antenatal care and surveillance is ongoing and eventually decisions must be made regarding the mode and timing of birth.

Once a baby is suspected to be LGA, antenatal care providers may utilise a variety of methods, or regimens, to monitor the baby’s growth and well‐being. The type and frequency of monitoring techniques vary considerably, and the choice of methods may be affected by other factors such as the presence of pre‐gestational or gestational diabetes mellitus (Campaigne 2007).

Antenatal fetal surveillance methods aim to provide information about the health of the baby (Grivell 2012). The results of surveillance methods then guide decisions about ongoing surveillance and the mode and timing of delivery, which may in turn reduce the risks to both the baby and the mother associated with fetal overgrowth and suspected LGA fetuses.

There are many methods that may be used in clinical practice, alone or in combination, to monitor suspected LGA fetuses and to assess those at risk (Grivell 2012). These include abdominal palpation, measuring symphysial fundal height (SFH), ultrasound assessment of baby’s growth, fetal movement counting, fetal heart rate assessment (cardiotocography), ultrasound assessment of the baby’s well‐being by serial growth measurements or liquor volume, and assessment of maternal glycaemia (Aye 2010; Chauhan 2005; Grivell 2012).

When LGA is suspected in a fetus, either from clinical assessment or maternal estimation, ultrasound is often used to assess growth using various standard measurements. These may include: abdominal circumference, head circumference, bi‐parietal diameter and femur length. These measurements can then be used to estimate fetal weight. Many formulae have been proposed, with the most widely used being Hadlock's (Hadlock 1985). Additional parameters to identify LGA infants and assess fetal well‐being include subcutaneous fat measurements on ultrasound, amniotic fluid volume, three‐dimensional (3D) volumetric estimates, umbilical artery dopplers and fetal magnetic resonance imaging (MRI) (Aye 2010; Chauhan 2005; Orland 2012). Ultrasound measurements can then be plotted against gestation along known percentile lines on a growth curve, to assess severity and timing of increasing growth. Serial ultrasound measurements can then identify those infants who are suspected to be LGA as well as those with acceleration of growth over time.

Ultrasound surveillance has variable accuracy in identifying LGA fetuses. The post‐test probability of detecting a macrosomic fetus on ultrasound has been assessed in a systematic review (Chauhan 2005); in an uncomplicated pregnancy it is variable, ranging from 15% to 79%. In comparison, the post‐test probability of clinical estimate in predicting a macrosomic fetus is 40% to 52% (Chauhan 2005). The use of a single early third‐trimester fetal biometry for the prediction of birth weight deviations showed 90% sensitivity for detection of macrosomia (De Reu 2008).

Macrosomia detection in higher‐risk populations such as women with diabetes has more consistency. The above systematic review found sensitivities ranging from 33% to 69%, specificities from 77% to 98%, and post‐test probabilities from 44% to 81%, in detecting macrosomia in women with diabetes (Chauhan 2005).

3D ultrasound has been used to identify suspected LGA fetuses, in particular by measuring subcutaneous fetal fat. There is some evidence that this improves weight prediction to within 5% of the actual weight (Lee 2001). However, this technique is not widely used.

Fetal MRI may have better predictive value in fetal weight estimation compared with ultrasound (Uotila 2000). However, due to limited availability and high cost, it is not routinely used in the diagnosis of macrosomia.

Although accurate, ultrasound is expensive when used as a screening tool for abnormal growth detection. A low‐cost option for detecting abnormal fetal growth is SFH.

A Cochrane review found insufficient evidence to determine whether SFH measurement is effective in detecting abnormal fetal growth, but only one trial was eligible for inclusion (Robert Peter 2012).

There is concern that identifying suspected LGA fetuses may lead to unnecessary maternal anxiety, investigations and interventions. A prospective observational study found that after an ultrasound, women with a suspected macrosomic fetus were more likely to have induction of labour or caesarean section, compared with actual macrosomia in the comparison group of all other births (Sadeh‐Mestechkin 2008). A previous Cochrane review found that induction of labour is not recommended for suspected macrosomia, as it does not alter the risk of maternal or neonatal morbidity (Irion 1998). Our review will therefore assess the risks as well as benefits of regimens of fetal surveillance for suspected LGA fetuses.

The estimated fetal weight from an ultrasound, or a SFH measurement, can be plotted on a customised growth chart, which adjusts for factors such as the mother's weight and height, ethnicity and number of babies she has had. This may make assessment of fetal growth more precise, differentiating between constitutional LGA and fetal overgrowth, reducing unnecessary consultations for investigations, and parental anxiety (González 2013).

How the intervention might work

We anticipated that by increasing the frequency of monitoring of a suspected LGA fetus, or using different methods of surveillance in combination, it would be possible to identify babies that would either benefit from earlier birth, or benefit from intervention to slow growth acceleration. Interventions to slow growth acceleration include dietary advice, lifestyle modification, and in women with diabetes or gestational diabetes blood glucose monitoring and insulin therapy (Aye 2010; Campaigne 2007; Chauhan 2005). This in turn may be associated with improved health outcomes for the mother and baby.

Why it is important to do this review

There has been a rise in the prevalence of LGA babies over the past few decades in many countries (Bergmann 2003; Gyselaers 2012; Lahmann 2009). In high‐income countries, there has been an overall 15% to 25% increase in the proportion of women giving birth to large infants (Aye 2010). Data are not as easily available for low‐ to middle‐income countries, where the risks are even greater due to the reduced availability of operative delivery options (Koyanagi 2013).

There is evidence that LGA is associated with an increased risk of maternal and neonatal complications. However, policies and protocols for fetal surveillance where accelerated fetal growth is suspected vary widely, which has led to uncertainty among clinicians about appropriate surveillance.

This systematic review aimed to assess the benefits and harms associated with different combinations of surveillance methods for the fetus estimated to be LGA.

Objectives

To assess the effectiveness or efficacy of different antenatal surveillance methods for the suspected large‐for‐gestational‐age (LGA) fetus on important health outcomes for the mother and baby.

Methods

Criteria for considering studies for this review

Types of studies

We had planned to include published and unpublished randomised controlled trials (RCTs), quasi‐randomised trials and cluster‐randomised trials comparing alternative surveillance regimens for women with suspected LGA infants. We planned to include conference abstracts where a full publication was unavailable.

Cross‐over studies were not eligible for inclusion.

Types of participants

Pregnant women after 20 weeks of pregnancy, where the fetus is suspected to be LGA. The definition of LGA was to be determined by the individual trials.

Types of interventions

Routine antenatal care compared with various regimens that are put in place due to a suspicion of LGA. Routine care was to be described by individual trials. Regimens were to include one or more surveillance methods. Surveillance methods may have included: increased antenatal visits without ultrasound, ultrasound surveillance of fetal growth, measurement of liquor volume, biophysical profile, umbilical artery dopplers, diabetes screening, monitoring maternal glycaemia, HbA1c monitoring, fetal movement counting or other tests of fetal well‐being.

We also planned to include head‐to‐head analysis of different regimens compared directly.

Types of outcome measures

Primary outcomes
Primary neonatal outcomes

  • Perinatal mortality (death of a fetus after 24 weeks' gestation or death of an infant in the first seven days of life)

  • Composite of serious neonatal morbidity (as defined by the trial authors)

Primary maternal outcomes

  • Caesarean section

  • Shoulder dystocia

Secondary outcomes
Secondary neonatal outcomes

  • Gestational age at birth

  • Birthweight/birthweight Z score

  • LGA variously described by authors

  • Customised birthweight centile

  • Low Apgar defined as less than seven

  • Cord blood acidosis

  • Neonatal hypoglycaemia

  • Birth length and head circumference

  • Fetal/neonatal adiposity

Secondary maternal outcomes

  • Induction of labour

  • Operative vaginal birth

  • Perineal trauma

  • Postpartum haemorrhage

  • Breastfeeding

  • Women's views of care

Longer‐term outcomes for the baby as a child

  • Long‐term neurodevelopmental outcomes

  • Longer‐term metabolic outcomes

    • Obesity

    • Hypertension

    • Type 2 diabetes

Use of healthcare services

  • Admission to neonatal special care or intensive care unit

  • Costs of antenatal monitoring regimen

Search methods for identification of studies

The following Methods section of this review is based on a standard template used by the Cochrane Pregnancy and Childbirth Group.

Electronic searches

We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register by contacting the Trials Search Co‐ordinator (30 August 2015).

The Register is a database containing over 20,000 reports of controlled trials in the field of pregnancy and childbirth. For full search methods used to populate the PCG Trials Register including the detailed search strategies for CENTRAL, MEDLINE, Embase and CINAHL; the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service, please follow this link to the editorial information about the Cochrane Pregnancy and Childbirth Group in The Cochrane Library and select the ‘Specialized Register ’ section from the options on the left side of the screen.

Briefly, the Cochrane Pregnancy and Childbirth Group’s Trials Register is maintained by the Trials Search Co‐ordinator and contains trials identified from:

  1. monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);

  2. weekly searches of MEDLINE (Ovid);

  3. weekly searches of Embase (Ovid);

  4. monthly searches of CINAHL (EBSCO);

  5. handsearches of 30 journals and the proceedings of major conferences;

  6. weekly current awareness alerts for a further 44 journals plus monthly BioMed Central email alerts.

Search results are screened by two people and the full text of all relevant trial reports identified through the searching activities described above is reviewed. Based on the intervention described, each trial report is assigned a number that corresponds to a specific Pregnancy and Childbirth Group review topic (or topics), and is then added to the Register. The Trials Search Co‐ordinator searches the Register for each review using this topic number rather than keywords. This results in a more specific search set which has been fully accounted for in the relevant review sections (Included, Excluded, Awaiting Classification or Ongoing).

In addition, we searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) for unpublished, planned and ongoing trial reports using the terms given in Appendix 1 (21 August 2015).

Searching other resources

We planned to search the reference lists of retrieved studies.

We did not apply any language or date restrictions.

Data collection and analysis

In this review, we did not identify any studies for inclusion. Our methods of data collection and analysis to be used in future updates of this review (if more data become available) are listed in Appendix 2.

Results

Description of studies

Results of the search

See:Figure 1


Study flow diagram.

Study flow diagram.

The search of the Cochrane Pregnancy and Childbirth Group’s Trials register did not retrieve any studies.

The search of ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) retrieved 11 reports; however, all included large‐for‐gestational‐age or macrosomia as an outcome only, and did not focus on interventions for suspected large‐for‐gestational‐age fetuses.

Risk of bias in included studies

No studies met the eligibility criteria for inclusion.

Effects of interventions

No studies met the eligibility criteria for inclusion.

Discussion

Large‐for‐gestational‐age (LGA) is known to be associated with increased risks to both the mother and baby, including increased risk of intra‐uterine death, fetal hypoxia, shoulder dystocia, brachial plexus injuries, bone fracture, hypoglycaemia, and admission to the neonatal intensive care unit (Esakoff 2009; Ju 2009). Maternal complications include prolonged labour, operative births including caesarean section, perineal trauma, postpartum haemorrhage and uterine rupture (Ju 2009; King 2012; Stotland 2004).

However, there is no evidence from randomised trials to guide which regimens of fetal surveillance should be used antenatally, once LGA is suspected, to impact these pregnancy outcomes. There are many different regimens which could be designed, but we found no evidence to support any individual regimen.

Potential biases in the review process

We conducted comprehensive searches of the Cochrane Pregnancy and Childbirth Trials Register and clinical trial registries. We did not identify any published, unpublished or ongoing studies that met the inclusion criteria for this review.

Agreements and disagreements with other studies or reviews

As we found no relevant eligible trials investigating the effect of antenatal surveillance regimens of suspected LGA fetuses, we are unable to draw any conclusions about the effectiveness of these regimens. Consequently, we are unable to identify any agreements/disagreements with other studies or reviews.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.