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Meta-Analysis
. 2017 Aug 11;8(8):CD007776.
doi: 10.1002/14651858.CD007776.pub3.

Preconception care for diabetic women for improving maternal and infant health

Affiliations
Meta-Analysis

Preconception care for diabetic women for improving maternal and infant health

Joanna Tieu et al. Cochrane Database Syst Rev. .

Abstract

Background: 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.

Objectives: To assess the effects of preconception care in women with diabetes on health outcomes for mothers and their infants.

Search methods: We searched Cochrane Pregnancy and Childbirth's Trials Register (31 January 2017) and reference lists of retrieved articles.

Selection criteria: 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.

Data collection and analysis: 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.

Main results: 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).

Authors' conclusions: 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.

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Conflict of interest statement

Joanna Tieu: is supported by an NHMRC postgraduate scholarship and Arthritis Australia Ken Muirden fellowship (jointly funded by the Australian Rheumatology Association and Roche).

Philippa Middleton: none known.

Caroline A Crowther: none known.

Emily Shepherd: none known.

Figures

1
1
Study flow diagram
2
2
Methodological quality graph: reviewers' judgements about each methodological quality item presented as percentages across all included studies
3
3
Methodological quality summary: reviewers' judgements about each methodological quality item for each included study
1.1
1.1. Analysis
Comparison 1 Preconception care versus standard care for diabetic women, Outcome 1 Pregnancy.
1.2
1.2. Analysis
Comparison 1 Preconception care versus standard care for diabetic women, Outcome 2 Behaviour changes associated with the intervention.

Update of

References

References to studies included in this review

Charron‐Prochownik 2008 {published and unpublished data}
    1. Charron‐Prochownik D, Ferons‐Hannan M, Sereika S, Becker D. Randomized efficacy trial of early preconception counseling for diabetic teens (READY‐girls). Diabetes Care 2008;31(7):1327‐30. - PMC - PubMed
    1. Thurheimer J, Sereika SM, Founds S, Downs J, Charron‐Prochownik D. Efficacy of the READY‐girls program on general risk‐taking behaviors, condom use, and sexually transmitted infections among young adolescent females with type 1 diabetes. Diabetes Educator 2016;42(6):712‐20. - PubMed
Charron‐Prochownik 2013 {published data only}
    1. Charron‐Prochownik D, Sereika SM, Becker D, White NH, Schmitt P, Powell AB 3rd, et al. Long‐term effects of the booster‐enhanced READY‐girls preconception counseling program on intentions and behaviors for family planning in teens with diabetes. Diabetes Care 2013;36(12):3870‐4. - PMC - PubMed
    1. Charron‐Prochownik DC. Preconception counseling starting at puberty: Providing evidence with "Reproductive‐health Education and Awareness of Diabetes in Youth for Girls" (READYGirls) program. Pediatric Diabetes 2011;12(Suppl 15):5.
Fischl 2010 {published data only}
    1. Fischl AF, Herman WH, Sereika SM, Hannan M, Becker D, Mansfield MJ, et al. Impact of a preconception counseling program for teens with type 1 diabetes (READY‐Girls) on patient‐provider interaction, resource utilization, and cost. Diabetes Care 2010;33(4):701‐5. - PMC - PubMed

References to studies excluded from this review

DCCT 1996 {published data only}
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Mathiesen 2012 {published data only}
    1. Hod M, McCance DR, Ivanisevic M, Garcia S, Jovanovic L, Mathiesen ER, et al. Perinatal outcomes in pregnancy: a randomised trial comparing insulin detemir with NPH insulin in 310 subjects with type 1 diabetes. Diabetologia 2011;54(Suppl 1):S487.
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References to ongoing studies

NCT01788527 {published data only}
    1. Farrell A, Mergler S, Mason D, Sanchez J, Feig DS, Asztalos E. The use of logs and forms for the tracking of RT‐CGM devices in the CONCEPTT Trial. Clinical Trials 2013;10:S80.
    1. NCT01788527. Continuous glucose monitoring in women with type 1 diabetes in pregnancy trial (CONCEPTT). clinicaltrials.gov/ct2/show/NCT01788527 Date first received: 19 December 19 2012.
NCT02508779 {published data only}
    1. NCT02508779. Blood glucose training for women with type 1 diabetes contemplating pregnancy. clinicaltrials.gov/ct2/show/NCT02508779 Date first received: 21 July 2015.
NTR2742 {published data only}
    1. NTR2742. Improving preconceptional suboptimal glycaemic control in type 1 diabetes using RealTime Continuous Glucose Monitoring (RT‐CGMS): a randomised clinical trial. trialregister.nl/trialreg/admin/rctview.asp?TC=2742 Date first received: 8 February 2011.

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Tieu 2010
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