Background
Methods
Study population
Study design
Usual care
Shared care
Primary and secondary clinical outcomes
Data collection
Statistical analysis
Results
Characteristics of the trial women
Usual care (n = 361) | Shared care (n = 339) | ||
---|---|---|---|
Variables | Mean (SD) or n(%) | Mean (SD) or n(%) | P value†
|
At the 1
st
antenatal care visit
| |||
Age, year | 29.7(3.2) | 29.9(3.5) | 0.475 |
Ethnicity | |||
Han | 350(97.0%) | 329(97.0%) | 0.940 |
Others | 11(3.1%) | 10(3.0%) | |
Smoking status | 0.753 | ||
Ex-smoker | 16(4.4%) | 12(3.5%) | |
Current smoker | 3(0.8%) | 4(1.2%) | |
Alcohol intake | 0.507 | ||
Ex-occasional drinker | 97(26.9%) | 79(23.3%) | |
Current occasional drinker | 14(3.9%) | 16(4.7%) | |
Body height, cm | 163(4.5) | 162(5.1) | 0.091 |
Prepregnancy BMI, kg/m2
| 23.4(3.9) | 22.9(3.6) | 0.111 |
BMI classification | 0.365 | ||
Below 18.5 (underweight) | 23(6.4%) | 25(7.4%) | |
18.0-23.9 (normal weight) | 202(56.0%) | 206(60.8%) | |
24.0-27.9 (overweight) | 91(25.2%) | 77(22.7%) | |
28.0 and above (obesity) | 45(12.5%) | 31(9.1%) | |
Parity | |||
0 | 342(95.0%) | 323(95.3%) | 0.870 |
1 and more | 18(5.0%) | 16(4.7%) | |
Systolic BP, mmHg | 107(10.2) | 108(10.9) | 0.742 |
Diastolic BP, mmHg | 69(7.5) | 70(7.8) | 0.339 |
Gestational age at the first visit, weeks | 10.8(2.3) | 10.8(2.4) | 0.593 |
At screening for and diagnosis of GDM
| |||
GCT, mmol/L‡
| 8.9(8.3-9.8) | 9.0(8.4-9.8) | 0.364 |
Systolic BP, mmHg | 109(10.1) | 109(10.7) | 0.786 |
Diastolic BP, mmHg | 69(7.6) | 70(7.5) | 0.554 |
HbA1c, % | 5.0(0.5) | 5.0(0.5) | 0.771 |
OGTT | |||
Fasting PG, mmol/L | 5.0(0.5) | 5.1(0.6) | 0.084 |
1-h PG, mmol/L | 10.0(1.3) | 10.1(1.4) | 0.366 |
2-PG, mmol/L | 8.4(1.4) | 8.4(1.2) | 0.983 |
Fasting insulin, mIU/L‡
| 8.7(5.7-12.8) | 9.0(5.6-12.8) | 0.867 |
2-h insulin, mIU/L‡
| 86.1(51.1-128.8) | 82.6(50.9-123.1) | 0.703 |
Weight gain at OGTT, kg | 9.7(4.4) | 9.8(4.4) | 0.774 |
Gestational age at OGTT, weeks‡
| 26.3(25.4-27.1) | 26.3(25.4-27.4) | 0.410 |
Compliance of the SC women
Usual Care (n = 361) | Shared Care (n = 339) | ||
---|---|---|---|
Variables | Mean (SD) or n(%) | Mean (SD) or n(%) | P Value‡
|
Attended individual education sessions | |||
One session | - | 66(19.5%) | |
Two sessions | - | 47(13.9%) | |
Three sessions | - | 226(66.7%) | |
Attended group education sessions | |||
None | - | 133(39.2%) | |
One session only | - | 101(29.8%) | |
Two and more sessions | - | 105(31.0%) | |
At 30
th
gestational weeks
| |||
Attended the 30 gestational week follow-up | - | 247(72.9%) | |
Weight gain from entry to 30th gestational week, kg/weeka
| 0.1(0.5) | ||
Number of self-monitoring of blood glucose | - | 52(22) | |
Glycaemic control target achieved | - | 231(93.5%) | |
Energy intake, Kcal/day | - | 1832(347) | |
At 34
th
gestational weeks
| |||
Attended the 34
th
gestational week follow-up
| 221(61.2%) | 252(74.3%) | <0.001 |
Weight gain from entry to 34th gestational week, kg/weeka
| 0.31(0.32) | 0.23(0.35) | 0.012 |
Total number of self-monitoring of blood glucose | - | 72(24) | |
Glycaemic control target achieved | - | 203(80.6%) | |
Energy intake, Kcal/dayaa
| 1899(352) | 1886(344) | 0.718 |
HbA1c, %ab
| 5.2(0.5) | 5.2(0.5) | 0.252 |
HbA1c, mmol/mol | 33(3) | 33(3) | 0.252 |
Insulin use | 1(0.3%) | 4(1.2%) | 0.156 |
Commuting in the past monthac
| 0.731 | ||
Stay at home | 103(46.6%) | 114(45.2%) | |
Public transportation | 64(29.0%) | 71(28.3%) | |
Driving | 39(17.7%) | 53(21.1%) | |
Walking/biking | 15(6.8%) | 13(5.2%) | |
Engaged in leisure time physical activity in the past month: yes vs. noac
| 172(77.8%) | 212(84.5%) | 0.065 |
Reaching physical activity target in the past month (30 min per time, ≥7 times per week)ac
| 57(25.8%) | 86(34.3%) | 0.045 |
Patient health questionnaire (PHQ-9) Score as a continuous variablea
| 5.1(2.3) | 4.9(2.6) | 0.389 |
Patient health questionnaire (PHQ-9) Score as a categorical variablea
| 0.548 | ||
≥15 (major depression) | 1(0.5%) | 2(0.8%) | |
10-14 (minor depression) | 8(3.5%) | 14(5.6%) | |
<10 | 211(95.9%) | 236(93.7%) | |
At delivery
| |||
Weight gain during pregnancy, kgb
| 15.7(6.4) | 15.5(6.5) | 0.785 |
Weight gain from 34th gestational week to delivery, kg/weekc
| 0.62(0.54) | 0.61(0.60) | 0.896 |
Insulin use | 18(5.0%) | 25(7.4%) | 0.188 |
The number of obstetric visits since 28th gestational weeksd
| 7.6(2.5) | 7.8(3.0) | 0.509 |
Pregnancy outcomes
UC (n = 361) | SC (n = 339) | SC vs. UC | SC vs. UC | ||
---|---|---|---|---|---|
Outcomes | Mean (SD) or n(%) | Mean (SD) or n(%) | P value | Unadjusted RR (95% CI) | Adjusted RR†(95% CI) |
Delivery at a tertiary hospital | 237(65.7%) | 237(69.9%) | 0.228 | ||
Gestational weeks at delivery | 39.2(2.1) | 39.4(2.9) | 0.243 | ||
Primary outcome
| |||||
Birth weight ?4.0 kg | 63(17.5%) | 38(11.2%) | 0.019 | 0.64(0.44-0.93) | 0.66(0.45-0.95) |
Secondary outcome
| |||||
Pregnancy-induced hypertension | 16(4.4%) | 27(8.0%) | 0.052 | 1.80(0.99-3.28) | 1.77(0.98-3.21) |
Other infant outcomes
| |||||
Birth weight, g | 3469(574) | 3371(530) | 0.021 | ||
Body stature of neonates, cm | 50.2(1.9) | 50.1(1.8) | 0.248 | ||
Infant male gender | 190(52.9%) | 204(60.4%) | 0.048 | ||
Large for gestational age†
| 72(19.9%) | 44(13.0%) | 0.013 | 0.65(0.46-0.92) | 0.66(0.47-0.93) |
Birth weight ≥4.5 kg | 10(2.8%) | 7(2.1%) | 0.541 | 0.75(0.29-1.94) | 0.75(0.28-1.99) |
Birth weight < 2.5 kg | 14(3.9%) | 14(4.1%) | 0.865 | 1.06(0.52-2.20) | 1.00(0.48-2.08) |
Apgar score at 1 min <7 | 7(1.9%) | 0(0%) | 0.016 | ||
Neonatal hypoglycemia†
| 4(1.1%) | 2(0.6%) | 0.457 | 0.53(0.10-2.89) | 0.55(0.10-3.09) |
Birth trauma or shoulder dystocia | 0 | 0 | - | - | - |
Bone fracture | 0 | 0 | - | - | - |
Stillbirth or neonatal death | 4(1.1%) | 4(1.2%) | 0.929 | 1.06(0.27-4.22) | 1.01(0.27-3.84) |
Other maternal or delivery outcomes
| |||||
Induced labor | 1(0.3%) | 0 | - | ||
Preterm birth | 28(7.8%) | 18(5.3%) | 0.192 | 0.68(0.39-1.21) | 0.64(0.36-1.14) |
Premature rupture of membrane | 69(19.1%) | 49(14.5%) | 0.100 | 0.76(0.54-1.06) | 0.74(0.53-1.04) |
Caesarean delivery | 233(64.5%) | 239(70.5%) | 0.093 | 1.09(0.99-1.21) | 1.09(0.98-1.21) |
Preeclampsia | 8(2.2%) | 18(5.3%) | 0.031 | 2.40(1.06-5.44) | 2.35(1.05-5.26) |
Gestational hypertension | 8(2.2%) | 9(2.7%) | 0.706 | 1.20(0.47-3.07) | 1.18(0.46-3.05) |
Subgroup analysis
UC | SC | SC vs. UC | SC vs. UC | ||
---|---|---|---|---|---|
Outcomes | Mean (SD) or n(%) | Mean (SD) or n(%) | P value | Unadjusted RR (95% CI) | Adjusted RR†(95% CI) |
Among GDM diagnosed by the IADPSG’s criteria only
| |||||
n | 117 | 110 | |||
Birth weight, g | 3522(590) | 3454(496) | 0.352 | ||
Birth weight ≥4.0 kg | 25(21.4%) | 14(12.7%) | 0.085 | 0.60(0.32-1.09) | 0.62(0.34-1.13) |
Large for gestational age†
| 27(23.1%) | 21(19.1%) | 0.462 | 0.83(0.50-1.37) | 0.88(0.54-1.46) |
Pregnancy-induced hypertension | 3(2.6%) | 7(6.4%) | 0.163 | 2.48(0.66-9.36) | 2.48(0.67-9.26) |
Among GDM diagnosed by both IADPSG’s and WHO’s criteria
| |||||
n | 244 | 229 | |||
Birth weight, g | 3443(565) | 3332(542) | 0.030 | ||
Birth weight ≥4.0 kg | 38(15.6%) | 24(10.5%) | 0.097 | 0.67(0.42-1.08) | 0.67(0.41-1.09) |
Large for gestational age†
| 45(18.4%) | 23(10.0%) | 0.009 | 0.54(0.34-0.87) | 0.52(0.33-0.84) |
Pregnancy-induced hypertension | 13(5.3%) | 20(8.7%) | 0.146 | 1.64(0.84-3.22) | 1.56(0.79-3.06) |
Sensitivity analysis
UC (n = 470) | SC (n = 466) | SC vs. UC | ||
---|---|---|---|---|
Outcomes | Mean (SD) or n(%) | Mean (SD) or n(%) | P value | Unadjusted RR (95% CI) |
Delivery at a tertiary hospital | 314(66.8%) | 334(71.7%) | 0.107 | |
Gestational weeks at delivery | 39.1(2.1) | 39.4(2.5) | 0.063 | |
Primary outcome
| ||||
Birth weight ≥4.0 kg | 73(15.6%) | 58(12.5%) | 0.170 | 0.80(0.58-1.10) |
Secondary outcome
| ||||
Pregnancy-induced hypertension | 22(4.7%) | 33(7.1%) | 0.118 | 1.51(0.90-2.56) |
Other infant outcomes
| ||||
Birth weight, g | 3445(587) | 3415(527) | 0.412 | |
Body stature of neonates, cm | 50.2(2.0) | 50.2(1.8) | 0.694 | |
Infant male gender | 244(51.9%) | 271(58.2%) | 0.055 | |
Large for gestational age†
| 89(18.9%) | 65(14.0%) | 0.040 | 0.74(0.55-0.99) |
Birth weight ≥4.5 kg | 12(2.6%) | 14(3.0%) | 0.679 | 1.17(0.55-2.51) |
Birth weight < 2.5 kg | 22(4.7%) | 15(3.2%) | 0.251 | 0.68(0.36-1.31) |
Apgar score at 1 min <7 | 14(3.0%) | 3(0.6%) | 0.008 | 0.22(0.06-0.75) |
Neonatal hypoglycemia†
| 4(0.9%) | 2(0.4%) | 0.418 | 0.50(0.09-2.74) |
Birth trauma or shoulder dystocia | 0 | 0 | - | - |
Bone fracture | 0 | 0 | - | - |
Stillbirth or neonatal death | 5(1.1%) | 5(1.1%) | 0.989 | 1.01(0.29-3.46) |
Other maternal or delivery outcomes
| ||||
Induced labor | 2(0.4%) | 0 | 0.500 | |
Preterm birth | 37(7.9%) | 22(4.7%) | 0.047 | 0.60(0.36-1.00) |
Premature rupture of membrane | 83(17.7%) | 74(15.9%) | 0.466 | 0.90(0.68-1.20) |
Caesarean delivery | 302(64.3%) | 333(71.5%) | 0.018 | 1.11(1.02-1.22) |
Preeclampsia | 12(2.6%) | 21(4.5%) | 0.105 | 1.76(0.88-3.55) |
Gestational hypertension | 10(2.1%) | 12(2.6%) | 0.651 | 1.21(0.53-2.77) |