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运动对于改善孕前已患糖尿病女性母胎结局的作用

Declaraciones de intereses de los autores

Versión publicada: 21 diciembre 2017 Historial de versiones

https://doi.org/10.1002/14651858.CD012696.pub2
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研究背景

孕前已患糖尿病的孕妇有很高的风险，其胎儿、新生儿和产妇的不良结局风险会有所增加。随着糖尿病发病率的持续上升，找到能改善糖尿病孕妇及其胎儿健康结局的干预方法已成为当务之急。

运动已被证明对患有2型糖尿病的非孕女性有益，例如帮助控制血糖水平，减少内脏脂肪组织和降低血浆甘油三酯水平。而对于孕前已患糖尿病的孕妇来说，运动干预对产妇及其胎儿的作用尚不清楚。

先前一项Cochrane系统综述是关于“糖尿病孕妇的运动干预”的，其纳入了孕前糖尿病孕妇和妊娠期糖尿病妇女。该Cochrane综述现在被分为两个新的综述（按照新的标准）—— 一个关于妊娠期间糖尿病，另一个关于孕前已患的糖尿病（本综述）。

研究目的

目的是评估运动干预对改善孕前已患糖尿病女性母胎结局的作用。

检索策略

我们检索了Cochrane妊娠和分娩试验注册库（Cochrane Pregnancy and Childbirth’s Trials Register），ClinicalTrials.gov试验数据库和WHO国际临床试验注册平台（ICTRP）（2017年6月27日），以及纳入研究的参考文献。

标准/纳入排除标准

我们计划纳入发表或未发表的随机对照试验(RCT)或整群随机化试验，包括针对孕前已患糖尿病（1型或2型糖尿病）孕妇的任何类型的运动干预合并标准治疗与 1）仅使用标准治疗或 2）标准治疗合并另一种运动干预进行比较的全文研究和摘要研究。半随机对照试验和交叉试验被排除在外。会议摘要的处理方式与全文出版物相同。

关于妊娠期间糖尿病妇女的研究也被排除在外，因为已在Cochrane另一个单独的综述中被论述。

数据收集与分析

我们计划让两名综述作者独立评估我们按照检索策略找到的所有可能研究。对于符合条件的研究，两名综述作者会使用统一表格各自独立地提取数据。我们计划通过讨论或咨询第三方来解决存在的分歧。我们还计划采用GRADE方法来评估所发现证据。

主要结果

我们找到发现任何随机对照试验。

作者结论

没有来自随机对照试验的证据来评估运动干预对于改善孕前已患糖尿病女性母胎结局的作用。

迫切需要进行高质量的大型随机对照试验来确认运动干预是否安全，以及是否能改善糖尿病孕妇及其胎儿的健康结局。未来这一领域的研究可以利用本综述的标准化结果，来提高该领域试验间的一致性，并帮助以后的meta分析。

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.

运动对于改善孕前已患糖尿病女性及其胎儿结局的作用

问题是什么？

糖尿病是由于产生胰岛素的细胞遭到自身免疫破坏所致，从而使胰岛素生产水平降低（1型糖尿病），或引起机体组织对胰岛素产生抵抗（2型糖尿病）。其最终结果是血液中葡萄糖水平增高1型糖尿病孕妇常常使用胰岛素来调节血糖水平。而对患有2型糖尿病的女性而言，生活方式的改变，包括饮食和锻炼，是治疗中重要的一部分。有时可能还会合并使用口服降血糖药物（以降低血中葡萄糖浓度为目标的药物）或胰岛素来降低血糖水平。我们着手评估了运动干预对于孕前已患有1型或2型糖尿病的孕妇及其胎儿结局的影响。原有一个关于运动对糖尿病妊娠女性作用的综述现在被分为两部分——一个是针对发生妊娠期糖尿病的女性，而本综述是针对孕前已患糖尿病的女性。

为什么这很重要？

患有糖尿病的女性妊娠，会增加流产、胎儿过度生长（胎儿大于同孕期预期水平)、早产、死产或先天性缺陷发生的风险。新生儿也可能出现血糖低于正常值、血钙水平低以及胆红素过高的状况。长期随访表明，当糖尿病母亲所生的婴儿长大后，发生肥胖及2型糖尿病的风险会增加。

目前孕前已患有糖尿病的孕妇人数正在增加，当务之急是找到改善糖尿病孕妇及其胎儿健康结局的方法。我们已经知道运动可能利于未怀孕的2型糖尿病女性，因为运动可以改善她们的血糖水平以及降低血液中的甘油三酸酯水平。但我们不清楚的是，运动对于孕前已患糖尿病的孕妇和胎儿是否安全和有利。体育活动有助于增强体质和预防压力性尿失禁、下背部疼痛或抑郁，并且能帮助控制妊娠期间的体重增加。

我们发现了什么证据？

我们于2017年6月27日检索了相关证据。但我们没有找到任何的随机对照试验（RCT），将针对孕前已患糖尿病孕妇的任何类型的运动干预（合并标准治疗）与 1）仅使用标准治疗或 2）标准治疗合并另一种运动干预进行比较。

这意味着什么？

没有来自随机对照试验的证据来评估运动干预对于改善孕前已患糖尿病妇女母胎结局的作用。

迫切需要高质量、大规模的研究来查明运动干预是否安全，以及是否能改善糖尿病孕妇及其胎儿的健康结局。未来这一领域的研究可以利用本综述所陈列的成果，来提高该领域试验之间的一致性，并帮助今后的分析。

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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