What is the issue?
The aim of this Cochrane review was to find out if giving women with diabetes specialised care before they become pregnant has an impact on their health, and on the health of their future babies. We collected and analysed all relevant studies to answer this question (date of search: January 2017).
Why is this important?
If a woman has type 1 or type 2 diabetes, and she becomes pregnant, she is at a greater risk of high blood pressure, and her baby has a greater risk of being born early (preterm - before 37 weeks). In addition, her pregnancy makes it more likely she will develop one or more of the known complications of diabetes, such as heart disease, problems with the nervous system and eyesight problems. Babies born to mothers with type 1 or type 2 diabetes may be larger, and they have a higher risk of death and abnormality of the spinal column or brain. They are also at risk of developing type 2 diabetes in the long term.
Effective control of blood sugar level (glycaemic control) is part of diabetes care. The relationship between glycaemic control and better health outcomes for mothers and their babies indicates that specialist care before pregnancy (preconception care) could be of benefit. This involves education and support, and help with self-monitoring of blood sugar levels, and self-care.
We searched for studies which looked at preconception care in diabetes clinics.
What evidence did we find?
We found three randomised controlled trials, conducted at diabetes clinics in the USA. The total number of participants in the studies was 254. The participants were all adolescent girls involved in the programme READY-Girls (Reproductive-health Education and Awareness of Diabetes in Youth for Girls). Their care was compared with standard care.
None of these three trials gave us the information on the health outcomes we needed. In one trial, there were no pregnancies among the participants during the period of the study, and the other two trials’ reporting of pregnancy was not sufficient. There were no data about short and long term outcomes for the mothers and their babies, or about the use of the health service and related costs.
What does this mean?
Because the information is lacking, we have no evidence from this Cochrane review to guide practice on this topic. Further large, well-designed, randomised controlled trials are required. Three trials are ongoing and will be considered in the next update of this review.
There are insufficient RCT data available to assess the effects of preconception care for diabetic women on health outcomes for mothers and their infants.
More high-quality evidence is needed to determine the effects of different protocols of preconception care for diabetic women. Future trials should be powered to evaluate effects on short- and long-term maternal and infant outcomes, and outcomes relating to the use and costs of health services. We have identified three ongoing studies that we will consider in the next review update.
Infants born to mothers with pre-existing type 1 or type 2 diabetes mellitus are at greater risk of congenital anomalies, perinatal mortality and significant morbidity in the short and long term. Pregnant women with pre-existing diabetes are at greater risk of perinatal morbidity and diabetic complications. The relationship between glycaemic control and health outcomes for both mothers and infants indicates the potential for preconception care for these women to be of benefit. This is an update of the original review, which was first published in 2010.
To assess the effects of preconception care in women with diabetes on health outcomes for mothers and their infants.
We searched Cochrane Pregnancy and Childbirth's Trials Register (31 January 2017) and reference lists of retrieved articles.
Randomised controlled trials (RCTs) assessing the effects of preconception care for diabetic women. Cluster-RCTs and quasi-RCTs were eligible for inclusion but none were identified.
Two reviewers independently assessed study eligibility, extracted data and assessed the risk of bias of the included studies. We checked data for accuracy and assessed the quality of the evidence using the GRADE approach.
We included three trials involving 254 adolescent girls with type 1 or type 2 diabetes, with an overall unclear to high risk of bias. The three trials were conducted at diabetes clinics in the USA, and assessed the READY-Girls (Reproductive-health Education and Awareness of Diabetes in Youth for Girls) programme versus standard care.
Considering primary outcomes, one trial reported no pregnancies in the trial period (12 months) (very low-quality evidence, with downgrading based on study limitations (risk of bias) and imprecision); in the other two trials, pregnancy was an exclusion criterion, or was not clearly reported on. None of the trials reported on the other primary maternal outcomes, hypertensive disorders of pregnancy and caesarean section; or primary infant outcomes, large-for-gestational age, perinatal mortality, death or morbidity composite, or congenital malformations. Similarly, none of the trials reported on the secondary outcomes, for which we had planned to assess the quality of the evidence using the GRADE approach (maternal: induction of labour; perineal trauma; gestational weight gain; long-term cardiovascular health; infant: adiposity; type 1 or 2 diabetes; neurosensory disability).
The majority of secondary maternal and infant outcomes, and outcomes relating to the use and costs of health services were not reported by the three included trials. Regarding behaviour changes associated with the intervention, in one trial, participants in the preconception care group had a slightly higher score for the actual initiation of discussion regarding preconception care with healthcare providers at follow-up (nine months), compared with those in the standard care group (mean difference 0.40, 95% confidence interval -0.02 to 0.82 (on a scale of 0 to 4 points); participants = 87) (a summation of four dichotomous items; possible range 0 to 4, with 0 being no discussion).