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懷孕前已罹患糖尿病之孕婦實行運動介入，對於母親及胎兒之改善結果

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Versión publicada: 21 diciembre 2017 Historial de versiones

https://doi.org/10.1002/14651858.CD012696.pub2
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Background

Pregnancies with pre‐existing diabetes are high risk, with increased risk of poorer fetal, neonatal, and maternal outcomes. Identifying interventions to improving health outcomes for women with diabetes and their infants is a priority, as rates of diabetes continue to increase.

Exercise has been shown to have benefits for non‐pregnant individuals with pre‐existing type 2 diabetes, such as improving glycaemic control, and reducing visceral adipose tissue and plasma triglycerides. For pregnant women with pre‐existing diabetes, the effects of exercise interventions on the mother and her baby are unknown.

An earlier Cochrane review on 'Exercise for pregnant women with diabetes' considered both pre‐existing diabetes and gestational diabetes. That Cochrane review has now been split into two new reviews (following new protocols) ‐ one on gestational diabetes and one on pre‐existing diabetes (this review).

Objectives

To evaluate the effects of exercise interventions for improving maternal and fetal outcomes in women with pre‐existing diabetes.

Search methods

We searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) on 27 June 2017, and reference lists of retrieved studies.

Selection criteria

We had planned to include published or unpublished randomised controlled trials (RCT) or cluster‐randomised trials, in full text or abstract format that compared any type of exercise programme, added to standard care, targeted at women with known pre‐gestational diabetes (type 1 or type 2 diabetes), at any stage of pregnancy, compared with 1) standard care alone or 2) standard care plus another exercise intervention. Quasi‐randomised and cross‐over trials were excluded. Conference abstracts were handled in the same way as full‐text publications.

Women with gestational diabetes mellitus were excluded, as they were covered in a separate Cochrane review.

Data collection and analysis

We had planned that two review authors would independently assess all the potential studies we identified as a result of the search strategy. For eligible studies, two review authors would have independently extracted the data using an agreed form. We had planned to resolve discrepancies through discussion, or by consulting a third person. We also had planned to assess the evidence using the GRADE approach.

Main results

We did not identify any randomised controlled trials.

Authors' conclusions

There was no evidence from RCTs that evaluated the effects of exercise interventions for improving maternal and fetal outcomes in women with pre‐existing diabetes.

Good quality, large randomised controlled trials are urgently needed to identify exercise interventions that are safe, and improve health outcomes for women with pre‐existing diabetes and their babies. Future studies in this area could utilise the standardised outcomes in this review, in order to improve consistency between trials in this area, and aid future meta‐analysis.

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.

運動對於懷孕前已罹患糖尿病之婦女及其胎兒的改善結果

此文獻回顧的問題為何？

糖尿病是由於製造胰島素之細胞受到自體免疫破壞，使得體內胰島素濃度降低而致（第一型糖尿病），或由於身體組織對胰島素產生阻抗而引起（第二型糖尿病）。其最終結果為增加血中葡萄糖濃度。第一型糖尿病孕婦使用胰島素調節血中葡萄糖濃度。對第二型糖尿病孕婦而言，改變生活方式，包括飲食與運動，為治療中重要的一環。有時，可能會合併降血糖藥物（以降低血中葡萄糖濃度為目標的藥物）或胰島素以降低血中葡萄糖濃度。我們著手評估懷孕前罹患第一型或第二型糖尿病的孕婦進行運動介入對於母體與其胎兒之生產結果影響。一份早期文獻回顧將運動對於姙娠期間的糖尿病影響分成兩份報告– 一份針對姙娠糖尿病婦女，而此份則是針對懷孕前已罹患糖尿病的婦女。

為什麼很重要？

罹患糖尿病的婦女，懷孕時以下所述的風險會增加：流產、胎兒過度生長（胎兒較該預期懷孕週數大）、早產、胎兒出生時死亡或胎兒先天缺陷。新生兒可能會有血糖濃度低於正常值、血鈣濃度低及血中膽紅素過高的情形。長期追蹤的資料表示，患有糖尿病母親所生的嬰兒長大後，罹患肥胖症及第二型糖尿病的風險較高。

懷孕前已患有糖尿病的婦女人數正在增加，而當務之急是找出方法以改善糖尿病婦女及其胎兒的健康狀況。我們已知運動可能有利於未懷孕的第二型糖尿病婦女，這是由於運動改善她們的血中葡萄糖濃度及降低血中三酸甘油酯濃度。但我們不清楚的是，運動對於懷孕前已罹患糖尿病的婦女與其胎兒是否有益及安全。體育活動有助於增強身體健康及預防壓力性尿失禁、下背痛或憂鬱症，並且有助於控制姙娠期間體重增加。

我們找到了那些證據？

我們搜尋至2017年6月27日的相關證據。但我們沒有找到任何隨機對照試驗(RCT)，比較1) 懷孕前已罹患糖尿病的婦女僅接受標準治療，或2)懷孕前已罹患糖尿病的婦女接受標準治療合併任一運動計劃。

這代表的意思為何？

從隨機對照試驗中沒有證據評估運動對於改善懷孕前已患糖尿病婦女之母體及胎兒之狀況的影響。

此領域迫切需要優質且大量的研究以查明運動介入是否安全，以及是否可改善懷孕糖尿病婦女與其胎兒的健康。今後該領域的研究可以利用此文獻回顧列舉之結果，以提高試驗間的一致性，並助於之後的分析。

Authors' conclusions

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Implications for practice

There is no evidence from RCTs to evaluate the effects of exercise interventions for improving maternal and fetal outcomes in women with pre‐existing diabetes.

Implications for research

We identified no RCTs for inclusion in this review. Pre‐existing diabetes during pregnancy is associated with short‐ and long‐term adverse effects for the woman and her infant. Good quality, large randomised controlled trials are urgently needed to identify exercise interventions that are safe, and improve health outcomes for women with diabetes and their babies. Future studies in this area could utilise the standardised outcomes in this review in order to improve consistency between trials in this area, and aid evidence synthesis.

Background

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The original review, Exercise for diabetic pregnant women (Ceysens 2006), has now been split into two new reviews (following new protocols), to reflect the role of exercise for pregnant women with gestational diabetes and for pregnant women with pre‐existing diabetes.

  • Exercise for pregnant women with gestational diabetes for improving maternal and fetal outcomes (Ceysens 2016)

  • Exercise for pregnant women with pre‐existing diabetes for improving maternal and fetal outcomes (this review)

There will be similarities in the background, methods and outcomes between these two systematic reviews. Portions of the methods section of this protocol are based on a standard template used by the Cochrane Pregnancy and Childbirth Review Group.

Description of the condition

Diabetes and pregnancy

It is estimated that 2% to 5% of pregnant women have pre‐existing or gestational diabetes (CEMACH 2007). Up to 0.4% of women in the UK and 0.9% of pregnant women in the USA have pre‐existing diabetes (type 1 or type 2; CEMACH 2007; Correa 2015). The prevalence of type 1 and type 2 diabetes is increasing. The number of pregnant women with pre‐existing type 2 diabetes more than quadrupled in the USA between 1994 and 2004, overtaking the rates of pre‐existing type 1 diabetes (0.42% versus 0.33%; Albrecht 2010). This increase in type 2 diabetes in pregnant women has been partly attributed to increasing obesity and older mothers (ACOG 2005; Zhu 2016). Type 2 diabetes has particularly increased in certain minority ethnic groups (including people of African, black Caribbean, South Asian, Middle Eastern, and Chinese family origin; CEMACH 2007). An association between type 2 diabetes and socioeconomic status has also been noted (Correa 2015; Murphy 2009).

Type 1 diabetes tends to begin in childhood, while type 2 diabetes mellitus usually occurs later in adulthood. In type 1 diabetes, sudden onset of insulin deficiency is believed to be caused by an autoimmune attack of the insulin‐producing pancreatic beta‐cells (cells that store and release insulin; Galerneau 2004; Griffith 2004). In type 2 diabetes, tissues become resistant to the action of insulin and insulin secretion is disrupted, leading to increasing levels of glucose in the blood (Dunne 2005).

Gestational diabetes is characterised by glucose intolerance that begins, or is first detected, during pregnancy. The incidence of gestational diabetes is also increasing as a result of higher rates of obesity in the general population, and more pregnancies in older women. After a pregnancy with gestational diabetes, women have an increased risk of progression to ‘pre‐existing’ diabetes (i.e. type 2 diabetes) in the next pregnancy (Khambalia 2013).

Adverse outcomes for women and infants associated with pre‐existing diabetes

Pregnancies with pre‐existing diabetes are high risk, with increased risk of poorer fetal, neonatal, and maternal outcomes (Owens 2015). Women with type 1 diabetes have an elevated risk of pregnancy loss, perinatal mortality, fetal macrosomia (a fetus that is large‐for‐gestational age), and congenital malformations (NICE 2015; Platt 2002). This is also the case for women with pre‐existing type 2 diabetes (CEMACH 2007; Inkster 2006), although neonatal outcomes may be poorer when the mother has type 1 diabetes (Owens 2015). However, a systematic review found perinatal mortality to be higher for women with type 2 compared with type 1 diabetes (odds ratio 1.50, 95% confidence interval 1.15 to 1.96; Balsells 2009).

Organogenesis (development of organs) in early pregnancy can be affected by metabolic disruptions when there are high concentrations of maternal blood glucose. Cardiovascular malformations are the most common birth defects in infants born to diabetic mothers (Inkster 2006). Apart from macrosomia (high birthweight, often defined as more than 4000 g), other adverse outcomes for infants may include large‐for‐gestational age, shoulder dystocia (difficulty in delivering shoulders of baby), neonatal hypoglycaemia (blood sugar that is lower than normal), preterm birth, hyperbilirubinaemia (excess bilirubin), hypocalcaemia (lower than normal calcium), and neonatal intensive care admission (Jensen 2004; Macintosh 2006; Ray 2001; Walkinshaw 2005; Weintrob 1996). Long‐term follow‐up of the infants of diabetic mothers suggests that they also may have an increased risk of obesity and type 2 diabetes when older (Dabelea 2000).

In pregnant women with type 1 (insulin‐dependent) diabetes, insulin is used to control fluctuations in blood glucose concentrations throughout the day (Galerneau 2004). In type 2 diabetes, lifestyle changes (including diet and exercise) are the first line of treatment, with the option of using oral hypoglycaemic agents or insulin to lower blood glucose, if necessary. Therefore, management of diabetes in pregnancy aims for control of glucose concentrations, using careful combinations of diet, exercise, and insulin or other anti‐diabetogenic drugs (medication that aims to reduce blood sugar levels), if required (ACOG 2005; NICE 2015).

Description of the intervention

The American College of Sports Medicine defines physical activity as any bodily movement that is produced as a result of the contraction of skeletal muscle, and defines exercise as physical activity comprising planned, structured, and repetitive body movements, which are undertaken to improve one or more components of physical fitness (ACSM 2014).

Physical activity in non‐diabetic pregnant women has been shown to be beneficial. It has not been shown to be harmful to the fetus, and can potentially lead to long‐term health benefits for the mother. Observed benefits include cardio‐respiratory fitness, prevention of stress urinary incontinence, prevention of lumbar pain, decreased depression, and control of weight gain during pregnancy (Nascimento 2012).

In women with type 2 diabetes who were not pregnant, physical activity, combined with diet and hypoglycaemic medication, has been shown to be effective in maintaining glycaemic control (Tuomilehto 2001).

This evidence may not be generalisable to pregnant women with pre‐existing diabetes, but it does suggest that mild exercise during pregnancy may have the potential to reduce the risk of complications associated with pre‐existing diabetes.

The American College of Obstetricians and Gynecologists notes that physical activity during pregnancy appears to have benefits for most women and has few risks associated with it, although some adaptation may be required, due to anatomical and physiological changes in pregnancy (ACOG 2015). They recommend that pregnant women have a clinical evaluation prior to starting an exercise programme, to ensure that there are no medical contraindications, and that women be encouraged to participate in aerobic and strength‐conditioning exercises before, during, and after uncomplicated pregnancies.

ACOG 2015 recommends that aerobic exercise during pregnancy is contraindicated in a number of medical conditions, including:

  1. cardiac disease;

  2. restrictive lung disease;

  3. incompetent cervix or cerclage;

  4. multiple gestation at risk of preterm birth;

  5. persistent second or third trimester bleeding;

  6. placenta praevia after 26 weeks' gestation;

  7. preterm labour (current pregnancy);

  8. ruptured membranes;

  9. pre‐eclampsia or pregnancy‐induced hypertension;

  10. severe anaemia.

ACOG 2015 considers these activities safe to continue with, or initiate during an uncomplicated pregnancy, following medical advice:

  1. walking;

  2. swimming;

  3. stationary cycling;

  4. low‐impact aerobics;

  5. modified yoga (avoiding positions that result in decreased venous return);

  6. modified Pilates;

  7. racquet sports;

  8. running or jogging;

  9. strength training.

However, running, jogging, or strength training should be undertaken only after consultation with an obstetrical care provider (ACOG 2015). During pregnancy, the duration, frequency, and intensity of physical activity may have to be modified (Nascimento 2012).

ACOG 2015 recommends avoiding these activities during pregnancy:

  1. contact sports (e.g. ice hockey, soccer, boxing);

  2. activities with a high risk of falling (e.g. skiing, surfing, off‐road cycling);

  3. scuba diving;

  4. sky diving;

  5. 'hot yoga' or 'hot Pilates'.

How the intervention might work

Physical activity may improve glycaemic control in those with types 1 and 2 diabetes because of the interaction between insulin sensitivity and the uptake of glucose by skeletal muscles (Asano 2014). Skeletal muscle takes glucose from the blood using a membrane transporter; improved insulin sensitivity following regular physical activity can increase the efficiency of this transport mechanism (Chibalin 2000; Dela 1993; Hjeltnes 1998).

Why it is important to do this review

Pre‐existing diabetes during pregnancy is associated with short‐ and long‐term adverse effects for the woman and her infant. Identifying interventions to improving health outcomes for women with diabetes and their infants is a priority, as rates of diabetes continue to increase. Exercise has been shown to have benefits for non‐pregnant individuals with pre‐existing type 2 diabetes, such as improving glycaemic control, and reducing visceral adipose tissue (fat tissue located deep in the abdomen and around internal organs) and plasma triglycerides (fatty molecules found in the blood; Thomas 2006). The benefits and safety for a woman during pregnancy and for her baby remains unclear.

Objectives

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To evaluate the effects of exercise interventions for improving maternal and fetal outcomes in women with pre‐existing diabetes.

Methods

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Criteria for considering studies for this review

Types of studies

We had planned to include published or unpublished randomised controlled trials or cluster‐randomised trials in full‐text or abstract format. Quasi‐randomised and cross‐over trials were not eligible for inclusion; conference abstracts were handled in the same way as full‐text publications.

Types of participants

Pregnant women diagnosed with pre‐gestational diabetes (type 1 or type 2 diabetes), as defined by the trialists.

Women with gestational diabetes mellitus (GDM) were excluded, as they will be covered in a separate Cochrane review (Ceysens 2016).

Types of interventions

We had planned to include any type of exercise programme, added to standard care, targeted at women with known pre‐gestational diabetes (type 1 or type 2 diabetes), at any stage of pregnancy, compared with 1) standard care alone or 2) standard care plus another exercise intervention.

Types of outcome measures

Primary outcomes
Mother

  1. hypertensive disorders of pregnancy (as reported by the trialists, and including pre‐eclampsia, pregnancy‐induced hypertension, eclampsia);

  2. caesarean section.

Neonate and infant

  1. large‐for‐gestational age (more than 4 kg);

  2. perinatal mortality (stillbirth and neonatal mortality);

  3. mortality or morbidity composite (variously defined by trials, e.g. perinatal or infant death, shoulder dystocia, bone fracture, or nerve palsy);

  4. neurosensory disability (defined as any of the following: legal blindness, sensorineural deafness requiring hearing aids, moderate or severe cerebral palsy, developmental delay or impairment (defined as developmental quotient less than two standard deviations (SDs) below the mean).

Secondary outcomes
Short‐term maternal outcomes

  1. induction of labour;

  2. perineal trauma;

  3. placental abruption;

  4. postpartum haemorrhage (more than 500 mL blood loss, or otherwise defined by trialists);

  5. postpartum infection (as defined by trialists);

  6. weight gain during pregnancy;

  7. adherence to the intervention;

  8. behaviour changes associated with the intervention;

  9. relevant biomarker changes associated with the intervention (e.g. adiponectin, free fatty acids, triglycerides, high density lipoproteins, low density lipoproteins, insulin);

  10. sense of well‐being and quality of life (as defined by trialists);

  11. views of the intervention;

  12. breastfeeding (e.g. at discharge, six weeks postpartum);

  13. use of additional pharmacotherapy;

  14. glycaemic control during and at the end of treatment (as defined by trialists);

  15. maternal hypoglycaemia;

  16. maternal mortality.

Long‐term maternal outcomes

  1. postnatal depression (as defined by trialists);

  2. postnatal weight retention or return to pre‐pregnancy weight;

  3. body mass index (BMI);

  4. cardiovascular health (as defined by trialists, including blood pressure (BP), hypertension, cardiovascular disease, metabolic syndrome).

Neonatal and infant outcomes

  1. stillbirth;

  2. neonatal mortality;

  3. gestational age at birth;

  4. preterm birth (less than 37 weeks' gestation, and less than 32 weeks' gestation);

  5. Apgar score (less than seven at five minutes);

  6. macrosomia (higher than 90th percentile);

  7. small‐for‐gestational age (lower than 10th percentile);

  8. birthweight and z‐score;

  9. head circumference and z‐score;

  10. length and z‐score;

  11. Ponderal index;

  12. adiposity (including skin fold thickness, neonatal fat mass);

  13. shoulder dystocia;

  14. bone fracture;

  15. nerve palsy;

  16. respiratory distress syndrome;

  17. hypoglycaemia requiring treatment (as defined by trialists);

  18. hyperbilirubinaemia (as defined by trialists);

  19. neonatal hypocalcaemia (as defined by trialists);

  20. polycythaemia (as defined by trialists);

  21. relevant biomarker changes associated with the intervention (e.g. cord C‐peptide, cord insulin).

Later infant and childhood outcomes

  1. weight and z‐scores;

  2. height and z‐scores;

  3. head circumference and z‐scores;

  4. adiposity (e.g. as measured by BMI, skinfold thickness);

  5. BP;

  6. type 1 diabetes;

  7. type 2 diabetes;

  8. impaired glucose tolerance;

  9. dyslipidaemia or metabolic syndrome;

  10. educational achievement.

Child and adult outcomes

  1. weight;

  2. height;

  3. adiposity (e.g. as measured by BMI, skinfold thickness);

  4. cardiovascular health (as defined by trialists, including BP, hypertension, cardiovascular disease, metabolic syndrome);

  5. type 1 diabetes;

  6. type 2 diabetes;

  7. impaired glucose tolerance (as defined by trialists);

  8. dyslipidaemia or metabolic syndrome (as defined by trialists);

  9. employment, education, social status and achievement.

Health service use

  1. number of hospital or health professional visits (e.g. midwife, obstetrician, physician, dietitian, diabetic nurse);

  2. number of antenatal visits or admissions;

  3. length of antenatal stay;

  4. neonatal intensive care unit admission;

  5. length of postnatal stay (mother);

  6. length of postnatal stay (baby);

  7. costs to families associated with the management provided;

  8. costs associated with the intervention;

  9. cost of maternal care;

  10. cost of offspring care.

Search methods for identification of studies

The following methods sections of this review are based on a standard template used by Cochrane Pregnancy and Childbirth.

Electronic searches

We searched Cochrane Pregnancy and Childbirth’s Trials Register by contacting their Information Specialist (27 June 2017).

The Register is a database containing over 23,000 reports of controlled trials in the field of pregnancy and childbirth. For full search methods used to populate Pregnancy and Childbirth’s 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 Cochrane Pregnancy and Childbirth in the Cochrane Library and select the Specialized Register section from the options on the left side of the screen.

Briefly, Cochrane Pregnancy and Childbirth’s Trials Register is maintained by their Information Specialist 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 review topic (or topics), and is then added to the Register. The Information Specialist searches the Register for each review using this topic number rather than keywords. This results in a more specific search set that would have been fully accounted for in the relevant review section (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. We have provided the search terms in Appendix 1.

Searching other resources

We had planned to search the reference lists of retrieved studies. We did not apply any language or date restrictions.

Data collection and analysis

We did not identify any studies to include in this review. If we identify studies for inclusion in the next update, we plan to use the methods described in Appendix 2.

Results

Description of studies

We did not identify any randomised controlled trials that met the inclusion criteria for this review.

Results of the search

We searched Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) on 27 June 2017, and did not identify any randomised controlled trials that compared any type of exercise programme, targeted at women with known pre‐gestational diabetes (type 1 or type 2 diabetes).

See: Figure 1

Figure 1
Study flow diagram

Study flow diagram

Included studies

We did not identify any randomised controlled trials.

Excluded studies

We did not identify any randomised controlled trials.

Risk of bias in included studies

We did not identify any randomised controlled trials.

Effects of interventions

We did not identify any randomised controlled trials.

Discussion

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Summary of main results

We did not identify any RCTs for inclusion in this review. Therefore, it remains unclear whether exercise in pregnancy improves maternal and fetal outcomes for women with pre‐existing diabetes.

Overall completeness and applicability of evidence

There is a lack of evidence on exercise interventions for women with pre‐existing diabetes for improving maternal and fetal outcomes.

Quality of the evidence

There were no included studies.

Potential biases in the review process

We made every effort to minimise biases in the review process. We conducted a systematic search of the literature for randomised controlled trial evidence, and we did not use any restrictions for language or publication date.

We adhered to Cochrane methodology for searching, and in our plans for data extraction and analysis.

Agreements and disagreements with other studies or reviews

There were no RCTs on this review topic. Similarly, a brief search of the literature did not identify any observational studies on this topic to inform this discussion.

A physically active pregnancy is generally encouraged, with certain activities dependent on individual medical advice (ACOG 2015). NICE 2015 recommends maintaining a healthy body weight and establishing good glycaemic control preconception. However, they found no evidence to recommend or discourage exercise in pregnancy for women with type 1 or 2 diabetes. Though exercise is beneficial for non‐diabetic pregnant women and is thought to cause no harm to the fetus (Nascimento 2012), evidence regarding the safety of exercise in pregnancy for diabetic women is lacking.

Study flow diagram
Figuras y tablas -
Figure 1

Study flow diagram

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