Background
Methods
Type of studies
Type of participants
Type of intervention
Type of outcome
Maternal outcomes
Neonatal outcomes
Exclusion criteria
Search strategy
Identification of included studies
Data extraction and studies assessment
Results
Study/Year of Publication Reference (country) | Participants | Intervention | Outcome | Risk of Bias (Notes) |
---|---|---|---|---|
66 participants with type I and type II who attended the preconception clinic and 119 participants with type I and type II diabetes who did not. | PCC included intensive insulin therapy, self-monitoring of blood glucose and dietary advice | The HA1C was significantly better in the PCC group than for the NPCC group (p = 0.01). The rate of cesarean section was higher in the PCC group than the NPCC. No differences were observed in abortion, Pre-eclampsia and preterm labor. Small for gestation age was more in the NPCC. | Medium (The baseline characteristics in relation to the vasculopathy are different. No blinding for the outcome assessment). | |
24 women with type I diabetes who attended the preconception clinic, and 74 women with type I diabetes who did not attend the preconception clinic. | PCC included education, counseling, glycemic control, and assessment of complications of diabetes such as nephropathy and retinopathy | Women who had PCC had significantly more spontaneous abortion, significantly lower level of HA1C at booking and throughout pregnancy and significantly heavier infants at birth than NPCC group (p < 0.05). There was no significant difference between the two groups in the frequency of infants with congenital malformations, gestation age at delivery or frequency of neonatal admission to the intensive care unit. | High (The study was not designed to assess the clinical outcomes of the preconception care but the differences in the socio-demographic features between the groups who attend the preconception care and those who did not. The target level for the glycemic control was not clear and the absolute level of Hb A1C at booking and all through pregnancy for the study and the control groups was not mentioned) | |
21 IDDM attended the pre-conception care and 40 did not attend | PCC included education, glycemic control self monitoring of blood glucose and Contraception | The investigated outcomes included polyhydramninos, pre-eclampsia, premature deliver, rate of cesarean section, rate of spontaneous and therapeutic abortion, perinatal and neonatal mortality, neonatal hypoglycemia and birth trauma. Significant reduction in the total fetal loss, neonatal mortality and congenital malformations (p < 0.05), the level of maternal HA1C in the 1st trimester (p < 0.05) and total adverse obstetrics complications (p < 0.05) | Low (good report, clear intervention description, the comparative groups received same antenatal intervention. No blinding for outcome assessment) | |
9 women with insulin dependent diabetes had preconception care and 11 women with insulin dependent diabetic who did not receive preconception care. | PCC included continuous insulin infusion initiated 2 months prior to conception | No significant difference in congenital malformations and HA1C level, between the two groups | High (small number of study and control group, many differences in the baseline characteristics in the severity of diabetes, 5 of the 11 control women were treated in the diabetic clinic in the hospital before pregnancy so they knew about the importance of glycemic control both groups have the same HA1C levels in early pregnancy) | |
84 women in preconception care and 110 women had no preconception care | PCC included glycemic and dietary control education, exercise and contraception. | The frequency of congenital abnormalities in the PCC group was 1.2% compared to 10.9% in the NPCC group (p < 0.05). There were 12 spontaneous abortion in the preconception care group and 14 in the group who received no preconception care. | Low (good report clear methodology) | |
28 women in the preconception group and 71 in the control group | PCC included dietary advice and glycemic control | HA1C concentration in the PCC group was lower than in the NPCC group (p < 0.0008). Spontaneous abortion rate was lower (p < 0.04) and there was no congenital malformations in either group. | Medium (52% of preconception care patients dropped out, no blinding in the assessment of the outcome) | |
110 women with type I diabetes attended the preconception care clinic and 180 women with type I diabetes did not attend the preconception care clinic | PCC included: Glycemic control, folic acid supplementation, smoking cessation, education. | There was significant improvement in the outcome between the PCC group and the NPCC group in the rate of spontaneous abortion (p < 0.056) and in the rate of preterm delivery (p < 0.02). The rate of congenital malformations was lower in PCC group compared to the NPCC group (p < 0.065). the adverse outcome including malformations, still birth and neonatal death were significantly more in the latter group than the former one (p < 0.026) | Low (Baseline characteristics in both groups were similar; the prospective nature of the study ascertained the completeness of the follow up, the completeness of the baseline and the outcome data. Use of appropriate statistical tests such as logistic regression analysis confirmed the association between the preconception care and outcomes). | |
62 women with either type I or type II diabetes who received preconception counseling and 123 women with either type I or type II diabetes who did not receive preconception counseling | PCC included counseling by health professional the control group received no counseling. | PCC group had significantly less perinatal mortality than the NPCC group (OR3.9 CI 1.2-13.9) and insignificantly less congenital malformations (OR 4.2 CI 0.5-29.7) | High (Base line characteristics of the two groups were significantly different in age, duration of diabetes and smoking all are confounding factors for the outcomes. The two groups did not receive the same antenatal intra-partum and postnatal care. The assessor of the congenital malformation was not blinded) | |
172 women with either type I or type II diabetes who received PCC and 260 women with either type I or type II diabetes who did not receive PCC | PCC included education, assessment of diabetes complications glycemic control self monitoring of blood glucose and Contraception | PCC group had significantly less perinatal mortality than the NPCC group, (p < 0.005) for type 1 diabetics and significantly less congenital malformations, (p < 0.005) for type 1 diabetics | Low (cases and control were well defined and comparable, selection bias is unlikely as consecutive cases were enrolled, the prospective nature of the study ascertained the completeness of the follow up, the completeness of the baseline and the outcome data) | |
15 women with pre-existing diabetes received PCC and 112 women with pre-existing diabetes did not receive PCC. | PCC included education, glycemic control self monitoring of blood glucose | The frequency of congenital abnormalities in the PCC group was 3/15 compared to 14/112 in the NPCC group. There was 1 spontaneous abortion in the PCC group and 9 in the group who received no PCC. | Low (cases and control were well defined and comparable, selection bias is unlikely as consecutive cases were enrolled, the prospective nature of the study ascertained the completeness of the follow up, the completeness of the baseline and the outcome data) | |
12 women with pre-existing diabetes received PCC and 12 women with pre-existing diabetes did not receive PCC | PCC glycemic control. | The frequency of congenital abnormalities in the PCC group was 3/12 compared to 2/12 in the NPCC group. In the PCC 6/12 neonates were macrosomic while 4/12 were macrosomic in the NPCC group. HbA1c was significantly lower in the first trimester in the PCC group compared to the NPCC group , (p < 0.01) | High (Both the study population and the control were not representative of the general diabetic population with frequency of diabetic vascular complications approaching 50%. The PCC components were not defined neither the target blood glucose) |
Year of Publication (country) | Participants | Intervention v comparison | Outcome | Risk of Bias |
---|---|---|---|---|
59 IDDM women attended a pre-conception clinic compared to 35 pregnant women who did not attend | PCC included: insulin and dietary glycemic control, advice on contraception and screening for diabetes complications | PCC group had significantly lower HA1C at the first trimester (p < 0.001) and significantly lower rate of spontaneous abortion (p < 0.001) compared to the NPCC group. | Low (Clear description of participants and intervention, noted confounding factors and well presented results. There was significant difference between the two groups in the diabetes complications before intervention) | |
47 women with IDDM 12 of them attended preconception care clinic and 35 women did not. | PCC included assessment of diabetes complications and glycemic control | The PCC group had significantly lower level of HA1C level compared to the NPCC group (p < 0.008). There were no congenital malformations in both groups. The cesarean section rate, the macrosomia rate and the small for gestation age were similar between the two groups | Medium (Due to the audit nature of the report there is no clear description of the intervention, some important confounders were not addressed such as White's classification and the outcome assessment was not blinded ) | |
197 attended PCC and 61 didn't attend | PCC included: contraception and glycemic control. | The rate of congenital malformations was significantly lower in the PPC group 1.0% than the NPPC group 8.2%, (p < 0.01). No significant difference in the level of HA1C during the first trimester between the two group | High (unclear description of the participants, the intervention and the outcome, the data of the preconception care were a subset of from different periods of the study) | |
44 women with type I diabetes attended the preconception clinic and 31 women with type I diabetes did not attend | PCC included assessment of diabetic complications, Contraception advice, Glycemic control and dietary advice | The NPCC group had significantly shorter duration of pregnancy (p < 0.05) significantly heavier mean birth weight (p < 0.05) than the PCC group. The two groups were similar in neonatal hypoglycemia, hypocalcaemia and respiratory distress syndrome | Low (Clear description of participants and intervention, noted confounding factors and well presented results. There was significant difference between the two groups in the diabetes complications before intervention) | |
620 pregnant women with insulin dependent diabetes,183 received pre-pregnancy care 437 women did not | PCC included: short hospitalization every 3 month until conception, education, self monitoring of blood glucose, assessment and treatment of diabetes complications and glycemic control | PCC group had significantly lower rate of congenital malformations 1.1% compared to the NPCC group 7.0% (p < 0.01) | Medium (Well described intervention, no blinding for the outcome, no description of the possible confounding factors) | |
21 IDDM 14 received preconception care and 7 did not | PCC included Glycemic control, counseling and blood glucose self monitoring | The PCC group had significantly better initial HA1C level (p < 0.0001), and lower mean birth weight (p < 0.05) | High (Unclear description of the participants, no description of possible confounding factors, no blinding in assessment of the outcome, small group, high target of HbA1C 5-9%) | |
143 IDDM women attended the preconception care clinic and 96 IDDM women did not attend | PCC included: education, glycemic controlled and contraception | PCC group had lower initial HbA1C as compared to NPCC group (p < 0.0001) and lower rate of congenital mal formations (p < 0. 005) , maternal hypoglycemia was significantly common in the PCC group than the NPCC (p < 0. 001) | Medium (Good description of interventions, contamination of the control who might know about the usefulness of the and the outcome assessment was not blinded ) |
Assessment of the methodological quality of the included studies
Study/Year of Publication (country) | Participants | Intervention | Outcome | Risk of Bias/Notes |
---|---|---|---|---|
Cases were 3278 Infants with congenital malformations related to diabetes. Controls were 3029 infants without congenital malformations. Maternal diabetes and intake of multivitamin were evaluated as a risk factors for congenital malformations | PCC included the use of multivitamin for 3 month before conception | The risk of congenital malformations related to diabetes was limited to infants of f diabetic mothers who had not taken multivitamin (OR 3.39 95% CI 1.79-8.63). Mother who had taken multivitamin had no increase risk of congenital malformations related to diabetes (OR 0.15 95% CI 0.00-1.99) | Medium (clear definition and selection of cases and controls, and outcomes, clearly defined outcome, not clear if the interviewers were blinded to the outcome, recall bias cannot be excluded during the interviews) |
Study/Year of Publication (country) | Participants | Intervention v comparison | Outcome | Risk of Bias/Note |
---|---|---|---|---|
187 had preconception intensive insulin therapy and 83 did not. | PCC included glycemic control and dietary advice. | There were 26 spontaneous abortion in the PCC group and 16 in the NPCC group. One still birth in the PCC group and 3 in the NPCC. Congenital mal formations were 5in the PCC group and 4 in the NPCC group. No differences on neonatal morbidity or maternal morbidity. Mean HbA1C in PCC group =7.4 ± 1.3 and in NPCC = 8.8 ± 1.7 | High (Unclear report of the outcome, the control group was aware of the importance of glycemic control and was repeatedly advised to change into intensive therapy when planning pregnancy. So intervention was not restricted to the preconception group. No specific target level of the blood sugar was stated for the preconception group) |
Outcome of PCC
Dichotomous outcomes of preconception care | No of studies [references] | Risk Ratio (95%Confedance interval) |
---|---|---|
Congenital malformation | 0.25(0.15,0.42) | |
Perinatal Mortality | 0.35(0.15,0.82) | |
Macrosomia | 1.03(0.81,1.30) | |
Cesarean Section | 1.08(0.96,1.22) | |
Preterm Delivery | 0.7 (0.55,0.90) | |
Pre-eclampsia | 0.92(0.62,1.35) | |
Neonatal Hypoglycemia | 0.65(0.39,1.08) | |
Maternal Hypoglycemia | 1.51(1.15,1.99) | |
Spontaneous Abortion | 0.78(0.55,1.11) | |
Respiratory Distress Syndrome | 0.55(0.26,1.16) | |
Small for Gestation Age | 0.26(0.05,1.41) | |
Continuous outcomes
|
Number of studies ( references)
|
Means difference (95% CI)
|
The difference in the level of glycosylated Hemoglobin A1c | 2.43(2.27,2.58) | |
The difference in gestational age at first visit to antenatal care | 1.32 (1.23, 1.40) |