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نقش مراقبت اینترکانسپشن برای زنان با سابقه دیابت بارداری به منظور بهبود پیامدهای مادران و نوزادان

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چکیده

پیشینه

دیابت ملیتوس بارداری (gestational diabetes mellitus; GDM) با پیامدهای نامطلوب برای سلامت مادران و نوزادان آنها، هم در دوران بارداری و هم در طولانی‌مدت همراه است. زنان دارای سابقه GDM در بارداری‌های بعدی در معرض خطر عود این بیماری هستند و ممکن است این مداخله در دوره اینترکانسپشن (interconception) تا بهبود پیامدهای سلامت مادران و نوزادان مزیتی به همراه داشته باشد.

اهداف

ارزیابی تاثیرات مراقبت اینترکانسپشن برای زنان با سابقه قبلی GDM بر پیامدهای سلامت مادران و نوزادان.

روش‌های جست‌وجو

ما پایگاه ثبت کارآزمایی‌های گروه بارداری و زایمان در کاکرین (7 اپریل 2017) و فهرست منابع مطالعات بازیابی شده را جست‌وجو کردیم.

معیارهای انتخاب

کارآزمایی‌های تصادفی‌سازی و کنترل شده، از جمله کارآزمایی‌های شبه‐تصادفی‌سازی و کنترل شده و کارآزمایی‌های خوشه‌ای‐تصادفی‌سازی شده، که تاثیر هرگونه پروتکل مراقبت اینترکانسپشن را با مراقبت استاندارد یا سایر اشکال مراقبت از اینترکانسپشن برای زنان دارای سابقه GDM بر پیامد سلامت مادران و نوزادان ارزیابی می‌کنند.

گردآوری و تجزیه‌وتحلیل داده‌ها

دو نویسنده مرور به‌طور مستقل از هم به ارزیابی واجد شرایط بودن مطالعات پرداختند. در نسخه‌های به‌روز شده بعدی این مرور، حداقل دو نفر از نویسندگان داده‌ها را استخراج و خطر سوگیری (bias) مطالعات وارد شده را ارزیابی می‌کنند؛ کیفیت شواهد با استفاده از سیستم درجه‌‏بندی توصیه‏، ارزیابی، توسعه و ارزشیابی (GRADE) ارزیابی خواهد شد.

نتایج اصلی

هیچ کارآزمایی واجد شرایط منتشر شده‌ای شناسایی نشد. ما یک کارآزمایی کامل تصادفی‌سازی و کنترل شده را شناسایی کردیم که برای بررسی تاثیرات یک رژیم غذایی و مداخلات ورزشی در مقایسه با مراقبت استاندارد در زنان دارای سابقه GDM طراحی شده بود، اما تاکنون، تنها نتایج مربوط به زنانی را گزارش کرده که در زمان تصادفی‌سازی باردار بودند (نه در دوره اینترکانسپشن). هم‌چنین یک کارآزمایی در حال انجام را روی زنان چاق دارای سابقه GDM شناسایی کردیم که قصد بارداری بعدی داشتند، در این مطالعه تاثیر مداخلات شدید شیوه زندگی که با درمان لیراگلوتاید (liraglutide) حمایت می‌شود، در مقایسه با مراقبت معمول ارزیابی می‌شود. هم‌چنین یک کارآزمایی را شناسایی کردیم که برای بررسی تاثیرات کاهش وزن و مداخلات ورزشی در مقایسه با آموزش شیوه زندگی در زنان چاق دارای سابقه GDM با قصد بارداری بعدی، طراحی شده، اما هنوز منتشر نشده است. این کارآزمایی‌ها برای ورود به نسخه به‌روز شده بعدی این مرور مجددا در نظر گرفته خواهند شد.

نتیجه‌گیری‌های نویسندگان

نقش مراقبت اینترکانسپشن برای زنان دارای سابقه GDM هنوز هم مشخص نیست. کارآزمایی‌های تصادفی‌سازی و کنترل شده برای ارزیابی شکل‌ها و پروتکل‌های مختلف مراقبت اینترکانسپشن برای این زنان بر پیامدهای پری‌ناتال و طولانی‌مدت سلامت مادر و نوزاد، مقبولیت چنین مداخلات و هزینه‐اثربخشی مورد نیاز است.

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.

خلاصه به زبان ساده

مراقبت پیش از بارداری بعدی برای زنان مبتلا به دیابت بارداری

موضوع چیست؟

هدف این مرور کاکرین، بررسی تاثیر مراقبت ویژه و هدف‌مند برای مادرانی است که حداقل در یک بارداری، متاثر از دیابت بارداری بوده‌اند. آیا این نوع مراقبت‌ها باعث بهبود سلامت مادر و نوزاد او حین و پس از بارداری بعدی می‌شود؟ برای پاسخ به این سوال تمام مطالعات مرتبط را جمع‌آوری و تجزیه‌وتحلیل کردیم (تاریخ جست‌وجو: اپریل 2017).

چرا این موضوع مهم است؟

دیابت بارداری (gestational diabetes; GD)، که دیابت ملیتوس بارداری (gestational diabetes mellitus; GDM) نامیده می‌شود، عدم تحمل گلوکز در دوران بارداری است. GDM می‌تواند منتهی به عوارض سلامت برای مادر شود. این عوارض ممکن است شامل فشار خون بالا در دوران بارداری و هنگام زایمان، پره‐اکلامپسی (pre‐eclampsia) (فشار خون بالا به همراه وجود پروتئین در ادرار) و ابتلا به دیابت نوع 2 در آینده باشد. زایمان بیشتر احتمال دارد القا شود. نوزادان متولد شده از مادران مبتلا به GDM با احتمال بیشتری با زایمان سزارین به دنیا می‌آیند و در کودکی یا نوجوانی مبتلا به دیابت می‌شوند. زنان مبتلا به GDM در معرض خطر ابتلا به این بیماری در دوران بارداری بعدی قرار دارند.

اگر مراقبت هدفمند بین تولد یک کودک و بارداری بعدی ‐ معروف به مراقبت اینترکانسپشن (interconception care) ‐ بروز GDM را کاهش دهد، آنگاه شاید این خطرات سلامت را نیز بتوان کاهش داد.

مراقبت اینترکانسپشن ممکن است شامل آموزش، مشاوره تغذیه و شیوه زندگی، مداخله با دارو و پایش دقیق از سلامت مادر با تمرکز بر تست تحمل گلوکز باشد.

ما چه شواهدی به دست آوردیم؟

برای کارآزمایی‌هایی که پیامدهای سلامت زنان و نوزادان را پس از مراقبت اینترکانسپشن خاص مورد بررسی قرار دادند و با پیامدهای مراقبت استاندارد (بدون مراقبت اینترکانسپشن از این نوع) مقایسه کردند، جست‌وجو انجام دادیم. جست‌وجوی ما یک کارآزمایی را شناسایی کرد که هنوز مجموعه کامل نتایج را منتشر نکرده، به علاوه دو کارآزمایی دیگر را که یکی هنوز در حال انجام است و دیگر هنوز منتشر نشده نیز شناسایی کردیم.

این یافته‌ها چه معنایی دارند؟

از آنجایی که در حال حاضر مطالعاتی در دسترس نیست، شواهد کافی برای گفتن اینکه مراقبت اینترکانسپشن برای زنان دارای سابقه GDM می‌تواند به بهبود سلامت مادران و نوزادان کمک کند، وجود ندارد. مطالعاتی با کیفیت بالاتر برای ارزیابی پیامدهای کوتاه‌مدت و طولانی‌مدت سلامت زنان و نوزادان و نیز ارزیابی تاثیرات بر خدمات سلامت مورد نیاز است.

Authors' conclusions

Implications for practice

The role of interconception care for women with a history of gestational diabetes mellitus (GDM) on maternal and infant health outcomes remains unclear.

Implications for research

Research should be conducted to investigate the effects of interconception care for women with a history of GDM on health outcomes for mothers and their infants. Although such trials are faced with difficulties in identifying women in this time period between pregnancies, women with a history of GDM do represent a population at risk for potentially reversible poor health outcomes.

Trials should consider the role of different forms of intervention including dietary, lifestyle and pharmacological therapies, in addition to the duration of such interventions. Such trials should not only evaluate the effects on maternal and infant health outcomes, but also the acceptability and cost‐effectiveness, to enable translation to clinical practice. Furthermore, future research should focus on long‐term follow‐up, evaluating the effects of such interventions on the long‐term health outcomes associated with GDM for both mothers and their infants.

Background

Description of the condition

Gestational diabetes mellitus (GDM) is defined as 'carbohydrate intolerance resulting in hyperglycaemia of variable severity with onset or first recognition during pregnancy' (WHO 1999). This definition includes women who first present with type 1 or type 2 diabetes during pregnancy, or where diabetes was previously undetected. Although GDM typically resolves following birth, it is associated with adverse outcomes for both mother and infant, both in the perinatal period and in the long term.

In subsequent pregnancies of women with a history of GDM, one of the main issues is recurrence of GDM and the associated outcomes. Irrespective of subsequent pregnancies, other long‐term considerations for these women include the development of type 2 diabetes, metabolic syndrome and the risk of cardiovascular disease.

Epidemiology

The reported incidence of GDM varies between different populations and the method and criteria by which the diagnosis is made, with some studies estimating that between 1% and 28% of pregnancies are affected by GDM (Jiwani 2012). Despite variation in diagnostic criteria, there is widespread agreement that the prevalence of diabetes, including GDM, is increasing across the world, in line with the escalating prevalence of obesity. In women with a history of GDM, recurrence occurs in 30% to 84% of subsequent pregnancies (Kim 2007).

A number of risk factors have been linked to GDM, including a history of GDM or glucose intolerance (Kim 2007), family history of first‐degree relatives with GDM or type 2 diabetes, ethnicity (e.g. African, Hispanic, South or East Asian, Native American and Pacific Islander), advanced maternal age, maternal high or low birthweight, high parity, a past history of a macrosomic (large) baby or a stillbirth (Petry 2010), polycystic ovarian syndrome (Toulis 2009), and maternal overweight or obesity (body mass index (BMI) equal to or greater than 25 kg/m² or 30 kg/m², respectively) (Torloni 2009).

Many of these risk factors are unmodifiable background characteristics of the women. It is therefore unsurprising that women with a history of GDM are at an increased risk of recurrent GDM. In addition to a history of GDM in a previous pregnancy, other risk factors for recurrence include ethnicity, maternal age, prepregnancy obesity, weight gain between pregnancies, a short interpregnancy interval and the number of previous pregnancies affected by GDM (Gaudier 1992; Getahun 2010; Kwak 2008; Major 1998). Certain characteristics of the pregnancy affected by GDM have also been reported to increase the risk of recurrence, specifically, earlier diagnosis of GDM, insulin requirement for blood glucose control and higher infant birthweight (Gaudier 1992;Kwak 2008; MacNeill 2001; Major 1998).

Screening and diagnosis of gestational diabetes

There is little consensus on the most appropriate methods by which to screen and diagnose GDM. Screening methods include selective‐ (risk factor‐) based screening, or universal screening, commonly performed between 24 and 28 weeks' gestation, with the use of random or fasting blood glucose concentrations and a 50 g oral glucose challenge test. Diagnostic testing commonly involves either a 75 g or 100 g oral glucose tolerance test, with various diagnostic cut‐offs used. These are addressed in the Cochrane reviews 'Screening and subsequent management for gestational diabetes for improving maternal and infant health' (Tieu 2014) and 'Different strategies for diagnosing gestational diabetes to improve maternal and infant health' (Farrar 2015).

Women with a history of GDM are acknowledged as being at high risk for both GDM recurrence and type 2 diabetes, and it is suggested that women with a history of GDM may require greater monitoring for glucose intolerance during subsequent pregnancies, as such through early self‐monitoring of blood glucose, or an early oral glucose tolerance test (NICE 2015).

Clinical features

Maternal

GDM is usually diagnosed before women experience symptoms, such as polyuria, polydipsia or fatigue. GDM is associated with increased rates of caesarean birth and pre‐eclampsia (Dodd 2007). As mentioned above, women who develop GDM represent a subset of the population prone to developing subsequent type 2 diabetes, in addition to recurrent GDM in future pregnancies. Within 10 years of women developing GDM, approximately half develop type 2 diabetes (Kim 2002). Furthermore, there is increasing evidence that women with a history of GDM may also be at increased risk of cardiovascular disease and metabolic syndrome (Reece 2009; Reece 2010; Vohr 2008).

Infant

Excess insulin due to maternal hyperglycaemia acts in two ways on the fetus. Firstly, insulin promotes fat deposition due to the state of nutrient excess (Pedersen 1954Whitelaw 1977). Insulin also acts as a growth factor, stimulating further growth of the infant in utero (Hunt 2007). Thus, fetal hyperinsulinaemia results in excessive growth of the fetus, leading to one of the major perinatal concerns in GDM, macrosomia (birthweight greater than 4000 g). Macrosomia may lead to birth trauma including shoulder dystocia, nerve palsies and fractures (Reece 2009; Reece 2010). GDM is associated with respiratory distress syndrome, neonatal hypoglycaemia (low blood glucose), hyperbilirubinaemia (high bilirubin levels), polycythaemia (excess red blood cells), and hypocalcaemia (low calcium) (Reece 2009; Reece 2010). In utero exposure to hyperglycaemia has long‐lasting effects on the infant, increasing their risk of future obesity and type 2 diabetes (Reece 2009; Reece 2010).

While there is relatively little reported on the effects of recurrent GDM on infants, infants born to mothers with recurrent GDM are likely to be larger, as measured by birthweight, incidence of large‐for‐gestational age, or macrosomia compared with infants born to mothers without recurrent GDM in a subsequent pregnancy (Spong 1998).

Management of GDM

The importance of management for women with GDM has been recognised (Crowther 2005; Landon 2009), and several Cochrane reviews have (or plan to) assess alternative management strategies for GDM (Alwan 2009), including lifestyle interventions (Brown 2017a), insulin (Brown 2016a), oral anti‐diabetic pharmacological therapies (Brown 2017b), exercise (Brown 2017c), dietary supplementation with myo‐inositol (Brown 2016b), and different intensities of glycaemic control (Martis 2016).

Description of the intervention

Interconception care may encompass a variety of interventions, including education, dietary and lifestyle advice, pharmacological intervention and active surveillance for illness and complications. It includes care between the birth of one child to the next pregnancy.

Internationally, clinical practice guidelines and consensus statements generally recommend postpartum assessment for continuing glucose intolerance after six to 12 weeks, by oral glucose tolerance testing to detect type 2 diabetes, and on a regular basis thereafter (i.e. every one to three years thereafter depending on other risk factors) (ACOG 2013; ADA 2017; CDA 2013; Metzger 2007; Nankervis 2014; NICE 2015). Despite such recommendations, a high proportion of women with previous GDM do not have testing for diabetes in the postpartum period (Blatt 2011). A Cochrane review evaluating 'Reminder systems for women with previous GDM to increase uptake of testing for type 2 diabetes or impaired glucose tolerance', showed low‐quality evidence supporting an increase in the uptake of testing for type 2 diabetes in women with previous GDM following the issue of postal reminders (Middleton 2014).

While often recommended, there is little evidence on what care women with a history of GDM should receive prior to a subsequent pregnancy. Clinical guidelines recommend that women be assessed preconceptually for a medical review and/or an oral glucose tolerance test, with early evaluation for glucose intolerance during pregnancy (ACOG 2013; NICE 2015). In addition to earlier identification and management of diabetes, interconception care after the postpartum period would ideally aim to target the modifiable risk factors for GDM, thus improving women's metabolic profiles.

How the intervention might work

In a survey of women with a history of GDM within the last five years, while 90% understood that previous GDM placed women at high risk of type 2 diabetes, only 16% believed that they themselves were at high risk of developing diabetes (Kim 2007b). This was partially explained by women planning to improve their behaviour in the future. When women considered the risks if they continued their current lifestyle, this risk perception rose to 39%. Importantly 85% of these women had plans for risk‐reducing behaviour (Kim 2007b). Another survey comparing women with children and a history of GDM with women with children without a history of GDM, found that those with a history of GDM were more likely to smoke and less likely to meet fruit and vegetable consumption recommendations (Kieffer 2006).

The interconception period provides an opportunity to provide advice on potential risks and possible interventions to improve health. Moreover, it provides the opportunity to identify undiagnosed pre‐existing diabetes. Since women with a history of GDM are at increased risk of diabetes, and pre‐existing diabetes in pregnancy is linked to poor maternal and infant health outcomes, it is important to identify and manage accordingly in the interconception period.

Risk factor reduction is a potential area of focus for these women, targeting modifiable risk factors such as maternal obesity where dietary and lifestyle interventions could be implemented and potentially benefit women with a history of GDM. Reducing maternal obesity itself may also lead to better maternal and infant health outcomes outside of its potential effect in the prevention of GDM. Regardless of whether women subsequently become pregnant, such interventions may improve the health of these women.

There is little information on the value of pharmacological agents such as oral anti‐diabetics for women with a history of GDM in the preconceptual period; assessed in the Cochrane review, 'Oral anti‐diabetic agents for women with pre‐existing diabetes mellitus/impaired glucose tolerance or previous gestational diabetes mellitus' (Tieu 2010b). The use of oral anti‐diabetic agents has been predominantly in the setting of polycystic ovarian syndrome or for prevention of type 2 diabetes in women with a history of GDM. 'Interventions for the prevention of type 2 diabetes in women with previous gestational diabetes' will be the focus of a planned Cochrane review (Li 2017).

Why it is important to do this review

Women with a history of GDM are recognised to be at high risk for recurrence in subsequent pregnancies, type 2 diabetes and cardiovascular disease, and therefore, for adverse maternal and infant health outcomes. While management of GDM is worthwhile, interconception care for these women also has the potential to improve maternal and infant health. Interconception care may also allow for detection and appropriate management of asymptomatic pre‐existing diabetes and provide an opportunity for risk factor reduction and, potentially, prevention of recurrent GDM and its sequelae.

Routine pre‐pregnancy care and preconception care for women with known diabetes mellitus are reviewed by the Cochrane reviews 'Routine pre‐pregnancy health promotion for improving pregnancy outcomes' (Whitworth 2009) and 'Preconception care for diabetic women for improving maternal and infant health' (Tieu 2010).

Objectives

To assess the effects of interconception care for women with a history of gestational diabetes mellitus on maternal and infant health outcomes.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs), including quasi‐RCTs and cluster‐RCTs. We plan to exclude cross‐over trials. We plan to exclude trials presented only as abstracts where information on risk of bias and primary or secondary outcomes cannot be obtained; we plan to reconsider these trials for inclusion once the full publication is available.

Types of participants

Women who have been diagnosed with gestational diabetes mellitus (GDM) in a previous pregnancy. Diagnosis of GDM made according to individual study criteria.

Types of interventions

Any protocol of care compared with no care and other forms of interconception care. Interventions may continue during pregnancy.

Types of outcome measures

For this update, we used the core outcome set agreed by consensus between review authors of Cochrane Pregnancy and Childbirth systematic reviews for prevention and treatment of gestational diabetes mellitus (GDM) and pre‐existing diabetes, which we adapted, as appropriate for this review question.

Primary outcomes
For women

  • GDM (diagnostic criteria as defined in individual trials)

  • Hypertensive disorders of pregnancy (including pre‐eclampsia, pregnancy‐induced hypertension, eclampsia)

  • Caesarean section

For children

  • Large‐for‐gestational age

  • Perinatal mortality (stillbirth or neonatal death)

  • Mortality or morbidity composite (e.g. death, shoulder dystocia, bone fracture or nerve palsy)

Secondary outcomes
For women

All women (interconception, and if pregnant, antenatal and postnatal)

  • Adherence to the intervention

  • Behaviour changes associated with the intervention

  • Sense of well‐being and quality of life

  • Views of the intervention

  • Glycaemic control during/at the end of the intervention (e.g. HbA1c, blood glucose)

  • Pregnancy

  • Weight gain

  • Body mass index (BMI)

Pregnant women

  • Spontaneous abortion/miscarriage/therapeutic abortion

  • Induction of labour

  • Perineal trauma

  • Placental abruption

  • Postpartum haemorrhage

  • Postpartum infection

  • Breastfeeding

  • Postnatal depression

Pregnant women with GDM

  • Use of additional pharmacotherapy

  • Hypoglycaemia

  • Mortality

Longer term

  • GDM in a subsequent pregnancy

  • Type 1 diabetes mellitus

  • Type 2 diabetes mellitus

  • Impaired glucose tolerance

  • Cardiovascular health (e.g. blood pressure, hypertension, cardiovascular disease, metabolic syndrome)

For children

Fetuses/neonates

  • Stillbirth

  • Neonatal death

  • Gestational age at birth

  • Preterm birth (before 37 weeks' gestation; before 34 weeks' gestation)

  • Apgar score less than seven at five minutes

  • Macrosomia

  • Small‐for‐gestational age

  • Birthweight and z score

  • Head circumference and z score

  • Length and z score

  • Ponderal index

  • Adiposity

  • Shoulder dystocia

  • Bone fracture

  • Nerve palsy

  • Respiratory distress syndrome

  • Hypoglycaemia

  • Hyperbilirubinaemia

Children/adults

  • Weight and z scores

  • Height and z scores

  • Head circumference and z scores

  • Adiposity (e.g. as measured by BMI, skinfold thickness)

  • Cardiovascular health (e.g. blood pressure, hypertension, cardiovascular disease, metabolic syndrome)

  • Education, employment and social status/achievement

  • Type 1 diabetes mellitus

  • Type 2 diabetes mellitus

  • Impaired glucose tolerance

  • Neurosensory disability

  • Employment, education and social status/achievement

For the use of health services

  • Number of hospital or health professional visits

  • Number of antenatal visits or admissions

  • Length of antenatal stay

  • Neonatal intensive care unit admission

  • Length of postnatal stay (mother)

  • Length of postnatal stay (baby)

  • Costs to families associated with the intervention

  • Costs associated with the intervention

  • Cost of maternal care

  • Cost of infant care

Search methods for identification of studies

The following methods section of this review is 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 (7 April 2017).

The Register is a database containing over 22,000 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;

  7. scoping search of clinical trials registries (ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP)).

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 which has been fully accounted for in the relevant review sections (Studies awaiting classification; Ongoing studies).

Searching other resources

We searched the reference lists of retrieved studies.

We did not apply any language or date restrictions.

Data collection and analysis

For methods used in the previous version of this review, seeTieu 2013.

Two review authors independently assessed for inclusion the reports identified as a result of the search strategy. No studies were eligible for inclusion. We would have resolved any disagreement through discussion with a third person.

Full methods of data collection and analysis to be used in future updates of this review, if eligible studies are identified, are given in Appendix 1.

Results

Description of studies

The updated search of Cochrane Pregnancy and Childbirth's register identified nine reports, relating to one trial (Koivusalo 2016), which we have listed as awaiting further classification, and one report relating to one trial (ISRCTN76189107) which we have listed as ongoing.

Koivusalo 2016 recruited 788 women including 235 women who were not pregnant during their first study visit (women with a previous history of gestational diabetes mellitus (GDM) (187) or a pre‐pregnancy BMI ≥ 30 kg/m2 (48)), and assessed a diet and exercise intervention compared with standard care. To date, however, results have only been reported for the subset of women who were pregnant during the first study visit. See Characteristics of studies awaiting classification.

We identified one new ongoing trial (ISRCTN76189107), which plans to include 50 obese women with a previous history of GDM pre‐pregnancy, and assess the effects of an intensive lifestyle intervention supported with liraglutide treatment compared with standard care. In the previous version of this review we identified one additional trial (NCT00924599), which to date, has not been published (and is thus listed as ongoing). This trial planned to include 12 obese women with a history of GDM and to assess the effects of a pre‐pregnancy weight loss and exercise intervention compared with lifestyle education. See Characteristics of ongoing studies.

See: Figure 1.


Study flow diagram.

Study flow diagram.

Risk of bias in included studies

No randomised controlled trials were included in the review.

Effects of interventions

No randomised controlled trials were included in the review.

Discussion

Summary of main results

One randomised controlled trial (Koivusalo 2016) was identified that was designed to assess the effects of interconception care on maternal and infant outcomes in women with a history of gestational diabetes mellitus (GDM), however to date, has only published results on women who were pregnant at randomisation, and not non‐pregnant women. A further two trials (ISRCTN76189107; NCT00924599), have been designed to assess the effects of lifestyle interventions for obese women with a history of GDM planning a subsequent pregnancy, however to date have not been published, or are ongoing.

Women with a history of GDM are at increased risk of recurrence of GDM in subsequent pregnancies, future impaired glucose tolerance and diabetes, cardiovascular disease and their sequelae. Given the potential poor outcomes identified in these women, they represent a group who could potentially benefit from intervention(s) aiming to prevent these outcomes. A number of interventions studied in women with a history of GDM after birth, most notably to increase follow‐up testing for impaired glucose tolerance or diabetes (Clark 2009), and interventions such as metformin and lifestyle modification to prevent type 2 diabetes (Ratner 2008) have demonstrated benefit. It remains uncertain how this may translate to interventions in the interconception period for the prevention of GDM recurrence.

In theory, the interconception period in these women represents a time in a high‐risk person's life for: identification and management of undiagnosed impaired glucose tolerance and type 2 diabetes; to initiate lifestyle interventions to potentially improve maternal and infant health outcomes; and to reinforce dietary and lifestyle behaviours for prevention of long‐term adverse health outcomes. No results from randomised controlled trials have been published relating to the effects of interventions in this interconception period for women with a history of GDM for improving health outcomes for women and their children. Given the potential benefits, it remains important to evaluate the effects of such interventions and identify the ideal form of intervention for these women.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.