Characteristics of participants
A total of 490 women who were followed at the obstetric clinic during the period of education delivery and PA prescription were invited to participate in the study following their delivery between November 2019 and September 2020. Of these, 465 (95%) consented to have their records and their babies' records accessed for this study, but 43 were excluded for a total of 422 (Figure 1). The GWG analyses were limited to the 394 women who delivered at term, the GD analyses included the 414 women who did not have other types of diabetes, the 411 women who did not already have high blood pressure were included in the GHT analysis, and all 422 newborns were included in the fetal macrosomia analyses.
For the comparison group, records of 475 women who delivered between January and September 2018 were assessed for eligibility. Of these, 81 women were excluded (Figure 1). Therefore, analyses were based on 394 mother-infant pairs. A total of 383 were included in the GWG analysis after exclusion of women with preterm delivery, 391 women had no other types of diabetes and were included in the GD analysis, the 389 women who did not already have high blood pressure were included in the GHT analysis. Because of one stillbirth at 18 weeks of pregnancy, 393 newborns were included for the macrosomia at birth analysis.
The group exposed to enhanced care and the group that received standard care did not differ with respect to women's mean age, mean pre-pregnancy weights, or pre-pregnancy BMI (Table 1). BMI categories, marital status, education level, maternal ethnic background, gestational age at first visit, primiparity, and history of GD, GHT, and depression or anxiety were also comparable between the two study groups.
Table 1 Baseline characteristics of study participants
|
Intervention (n=422)
|
Comparison group (n=394)
|
Age (years)a
|
29.2 ± 5.3
|
29.3 ± 5.1
|
Height (cm)a
|
163.7 ±7.1
|
163.6 ± 7.0
|
Weight before pregnancy (kg)a
|
71.5 ± 17.9
|
72.2 ± 19.7
|
BMI (kg/m2)a
|
26.7 ± 6.4
|
26.9 ± 7.0
|
BMI categories (n (%))
|
|
|
< 18.5 kg/m2
|
19/420 (4.5%)
|
14/393 (3.6%)
|
18.5-24.9 kg/m2
|
187/420 (44.5%)
|
186/393 (47.3%)
|
25.0-29.9 kg/m2
|
110/420 (26.2%)
|
94/393 (23.9%)
|
≥ 30 kg/m2
|
104/420 (24.8%)
|
99/393 (25.2%)
|
Marital status (n (%))
|
|
|
Single
|
36/407 (8.8%)
|
26/380 (6.8%)
|
Married
|
188/407 (46.2%)
|
199/380 (52.5%)
|
Common-law spouse
|
179/407 (44.0%)
|
153/380 (40.3%)
|
Education (n (%))
|
|
|
Without a high school diploma
|
38/410 (9.3%)
|
27/390 (6.9%)
|
High school diploma
|
65/410 (15.9%)
|
59/390 (15.1%)
|
College diploma/trade school
|
142/410 (34.6%)
|
128/390 (32.8%)
|
University diploma
|
165/410 (40.2%)
|
176/390 (45.1%)
|
Ethnic or racial background (n (%))
|
|
|
Caucasian
|
346/421 (82.2%)
|
340/392 (86.7%)
|
Other
|
75/421 (17.9%)
|
52/392 (13.3%)
|
Gestational age at first visit (week)a
|
11.1 ± 2.0
|
11.3 ± 1.68
|
First-born (n (%))
|
204/422 (48.5%)
|
204/394 (51.6%)
|
History of GD (n (%))
|
12/422 (2.8%)
|
9/394 (2.3%)
|
History of GHT (n (%))
|
12/421 (2.9%)
|
15/393 (3.8%)
|
History of depression/anxiety (n (%))
|
135/422(32.0%)
|
114/394(28.9%)
|
a mean ± standard deviation
Abbreviations: BMI Body mass index, GD Gestational diabetes, GHT Gestational hypertension.
Gestational weight gain
The odds of excess GWG were 29% lower in the group of women exposed to enhanced care compared with women who were followed during the standard care period (Table 2). The intervention was associated with a reduction in the proportion of women with excessive GWG in all pre-pregnancy BMI categories. Specifically, women who were exposed to the enhanced care and who started their pregnancies at normal weight, overweight, or obese had a greater likelihood of completing their pregnancies with a normal GWG, compared to women who received standard care. However, for women who were underweight at the beginning of their pregnancies, enhanced care was associated with a decreased likelihood of completing the pregnancy with a normal GWG as more of them ended with a low GWG. In sum, the average GWG was similar between women in the two groups.
Table 2 GWG in the intervention and comparison groups
|
Intervention
(n=422)
|
Comparison group (n=394)
|
p-value
|
unadjusted Odd ratio (95% CI)
|
adjusted Odd ratio (95% CI)
|
GWG
|
|
|
|
|
|
Normal GWG
|
156/392 (39.8%)
|
124/382 (32.5%)
|
0,093
|
Reference
|
Reference
|
Low GWG
|
92/392 (23.5%)
|
95/382 (24.9%)
|
|
0.77 (0.53 - 1.15)
|
0.76 (0.52 - 1.10)
|
Excessive GWG
|
144/392 (36.7%)
|
163/382 (42.7%)
|
|
0.70 (0.51 - 0.97)
|
0.71 (0.51 - 0.99)
|
Normal GWG by BMI
|
|
|
|
|
|
BMI < 18.5
|
6/17 (35.3%)
|
9/13 (69.2%)
|
0.100
|
0.15 (0.02 - 0.94)
|
0.17 (0.02 - 1.42)
|
BMI 18.5–24.9 kg/m2
|
84/171 (49.1%)
|
72/185 (38.9%)
|
0.102
|
1.35 (0.83 - 2.20)
|
1.35 (0.83 - 2.22)
|
BMI 25.0–29.9 kg/m2
|
36/103 (35.0%)
|
28/91 (30.8%)
|
0,629
|
0.92 (0.36 - 2.38)
|
0.84 (0.30 - 2.34)
|
BMI ≥ 30 kg/m2
|
30/101 (29.7%)
|
15/93 (16.1%)
|
0,062
|
2.67 (1.12 - 6.37)
|
3.37 (1,31 - 8,67)
|
Excessive GWG by BMI
|
|
|
|
|
|
BMI < 18.5
|
2/17 (11.8%)
|
2/13 (15.4%)
|
0.100
|
0.22 (0.02 - 2.67)
|
0.23 (0.01 - 5.63)
|
BMI 18.5–24.9 kg/m2
|
36/171 (21.1%)
|
54/185 (29.2%)
|
0.102
|
0.77 (0.44 – 1.36)
|
0.78 (0.43 - 1.40)
|
BMI 25.0–29.9 kg/m2
|
53/103 (51.5%)
|
53/91 (58.2%)
|
0,629
|
0.71 (0.29 - 1,75)
|
0.70 (0.27 - 1,85)
|
BMI ≥ 30 kg/m2
|
53/101 (52.5%)
|
54/93 (58.1%)
|
0,062
|
1.31 (0.64 - 2,69)
|
1.68 (0.74 - 3,79)
|
|
Intervention
(n=422)
|
Comparison group (n=394)
|
p-value
|
unadjusted β (95% CI)
|
adjusted β (95% CI)
|
Total GWG (kg)a
|
12.2 ± 5.4 (n = 394)
|
12.4 ± 5.4 (n = 383)
|
0,642
|
0.02 (-0.58 - 0.95)
|
0.13 (-0.66 - 0.78)
|
Total GWG by BMI (kg)a
|
|
|
|
|
|
BMI < 18.5 kg/m2
|
12.1 ± 4.5 (n = 17)
|
14,5 ±3.4 (n = 13)
|
0,133
|
0.08 (-0.76 - 5.42)
|
0.21 (-1.02 - 5.35)
|
BMI 18.5–24.9 kg/m2
|
13.5 ± 4.6 (n = 171)
|
13.8 ± 4.6 (n = 185)
|
0,646
|
0.01 (-0.74 - 1.19)
|
0.08 (-0.83 - 1.07)
|
BMI 25.0–29.9 kg/m2
|
12.2 ± 5.2 (n = 103)
|
12.8 ± 5.4 (n = 91)
|
0,447
|
0.03 (-0.92 - 2.07)
|
0.03 (-1.06 - 2.02)
|
BMI ≥ 30 kg/m2
|
10.1 ± 6.2 (n = 101)
|
9.1 ± 5.9 (n = 93)
|
0,262
|
0.07 (-2.71 - 0.74)
|
0.10 (-3.07 - 0.23)
|
a mean ± standard deviation
Abbreviations: BMI Body mass index, GWG Gestational weight gain
GWG is adjusted for GD, BMI, parity, age & education of the mother
The two study groups also differed significantly in their probability of developing GHT (Table 3). In the enhanced care group, 3.2% of women developed GHT compared to 11.8% of women who received standard care. The women who received the enhanced care therefore had 73% lower odds to develop GHT. The mean systolic and diastolic BP during pregnancy was higher in the women in the standard care group. However, there was no difference between the two study groups with respect to GD. The same was true for mean blood glucose one hour after ingestion of 50 grams of glucose, which did not differ between the two groups.
Among the other outcomes studied, the odds of labor induction or C-section due to pregnancy complications were 81% lower in the group that received enhanced care compared to the group that received standard care. Specifically, 1.2% of the women in the enhanced care group had an induction of labor and delivery due to GHT and/or preeclampsia compared to 6.4% of the women in the comparison group. There was also a difference between the groups in the odds of induction of labor and delivery for other reasons (oligohydramnios, post-term, etc.), but induction of labor and delivery due to GD or macrosomia did not differ between the groups. In addition, although the distribution of methods of delivery did not differ between the study groups, perineal tears and episiotomies were more common among women in the standard care group compared to women in the enhanced care group.
Table 3 Maternal and obstetrical outcomes
|
Intervention (n=422)
|
Comparison group (n=394)
|
p-value
|
unadjusted Odd ratio (95% CI)
|
unadjusted Odd ratio (95% CI)
|
GD (n (%))
|
13/414 (3.1%)
|
15/391 (3.8%)
|
0.590
|
0.81 (0.38 - 1.73)
|
0.48(0.12 - 1.94)
|
Abnormal glycemia one h after ingestion of 50 g of glucose (mmol/L) (n (%))
|
53/408 (48.2%)
|
57/382 (51.8%)
|
0.433
|
1.16 (0.79 - 1.76)
|
1.77 (0.95 - 3.32)
|
GHT (n (%))
|
13/411 (3.2%)
|
46/389 (11.8%)
|
<0.001
|
0.24 (0.13 – 0.46)
|
0.27 (0.14 - 0.53)
|
Induction of labor
GD (n (%))
GHT/preeclampsia n (%)
Macrosomia (n (%))
Other (n (%))
|
2/414 (0.5%)
5/411 (1.2%)
1/422 (0.2%)
15/422 (3.6%)
|
7/391 (1.8%)
25/389 (6.4%)
2/394 (0.5%)
34/394 (8.6%)
|
0.078
<0.001 0.523
0.002
|
0.27 (0.06 -1.29)
0.18 (0.07 - 0.47)
0.48 (0.04 -5.42)
0.39 (0.21 - 0.73)
|
0.31 (0.06 - 1.52)
0.18 (0.07 - 0.49)
0.49 (0.04 -5.42)
0.41 (0.22 - 0.77)
|
Induction of labor or C-section due to GD, GHT/preeclampsia, obesity, or macrosomia (n (%))
|
7/403 (1.7%)
|
35/387 (9.0%)
|
<0.001
|
0.18 (0.08 - 0.41)
|
0,19 (0.08 - 0.43)
|
Type of delivery
Vaginal (n (%))
C-section (n (%))
|
297/422 (70.4%)
125/422 (29.6%)
|
277/393 (70.5%)
116/393 (29.6%)
|
0.974
|
1.01 (0.74 - 1.36)
|
1.01 (0.74 - 1.38)
|
Perineal tears
Perineum intact (n (%))
1st degree (n (%))
2nd degree (n (%))
3rd degree (n (%))
Episiotomy (n (%))
|
58/293 (19.8%)
86/293 (29.4%)
136/293 (46,4%)
13/293 (4.4%)
28/293 (9.6%)
|
41/270 (15.2%)
66/270 (24.4%)
143/270 (53.0%)
19/270 (7.0%)
35/270 (13.0%)
|
0.151
0.190
0.121
0.183
0.200
|
1.38 (0.89 - 2.14)
1.28 (0.88- 1.87)
0.76 (0.55 - 1.07)
1.61 (0.29 - 1.27)
0.70 (0.41 -1.20)
|
1.42 (0.89 - 2.25)
1.28 (0.88 - 1.87)
0.77 (0.55 -1.07)
0.62 (0.30 - 1.29)
0.71 (0.42 – 1.20)
|
|
Intervention (n=4222)
|
Comparison group (n=394)
|
p-value
|
unadjusted β
(95% CI)
|
adjusted β
(95% CI)
|
Glycemia one hr after ingestion of 50 g of glucose (mmol/L)a
|
5,9 ± 1,6 (n = 408)
|
6,2 ± 1,7 (n = 382)
|
0.125
|
0.03 (-0.05 - 0.41)
|
0.13 (0.41 - 0.64)
|
Systolic BP (mmHg)a
|
108.3 ± 8.7 (n=422)
|
110.1 ± 9.6 (n=394)
|
0.005
|
0.01 (0.55 - 3.07)
|
0.24 (0.61 - 2.85)
|
Diastolic BP (mmHg)a
|
63.1 ± 5.5 (n=422)
|
63.9 ± 6.3 (n=394)
|
0.036
|
0.01 (0.06 - 1.67)
|
0.19 (0.04 - 1.50)
|
a mean ± standard deviation
Abbreviations : GHT Gestational hypertension, BP Blood pressure, GD Gestational diabetes
GD is adjusted for BMI, parity, history of GD and macrosomia, age & education of the mother
GHT is adjusted for GD, BMI, parity, history of GHT, age & education of the mother
Induction of labor, type of delivery and perineal tears adjusted for BMI, age, and parity
Neonatal outcomes
The average birth weight of newborns was significantly lower among newborns in the enhanced care group compared to those in the standard care group. Similarly, the odds of fetal macrosomia were 44% lower among newborns in the enhanced care group compared with newborns in the standard care group. However, there were no statistically significant differences between the two study groups regarding premature birth, shoulder dystocia, and Apgar score at one and five minutes of life.
Table 4 Neonatal outcomes in the study groups.
|
Intervention (n=422)
|
Comparison group (n=393)
|
p-value
|
unadjusted Odd ratio (95% CI)
|
unadjusted Odd ratio (95% CI)
|
Sex
Female (n (%))
Male (n (%))
|
215/421 (51.1%)
206/421 (48.9%)
|
186/389 (47.8%)
203/389 (52.2%)
|
0.355
|
0.87 (0.66 - 1,15)
|
0.89 (0.67 - 1.17)
|
Macrosomia (n (%))
|
30/396 (7.6%)
|
46/380 (12.1%)
|
0.034
|
0.60 (0.37- 0.97)
|
0.56 (0.34 - 0.93)
|
Premature birth (n (%))
|
26/422 (6.2%)
|
14/393 (3.6%)
|
0.085
|
1.78 (0.92 - 3.47)
|
1.81 (0.93 - 3.53)
|
Shoulder dystocia (n (%))
|
26/293 (8.9%)
|
34/270 (12.6%)
|
0.153
|
0.68 (0.40 -1.16)
|
0.65 (0.38 - 1.12)
|
|
Intervention (n=422)
|
Comparison group (n=393)
|
p-value
|
unadjusted β (95% CI)
|
unadjusted β (95% CI)
|
Weight at birth (g)
|
3400.0 ± 450.8
(n =396)
|
3470.1 ± 445.8
(n =380)
|
0.030
|
0.01 (6.85-133.25
|
0.17 (14.05 - 132.43)
|
Apgar score at 1 min (n (%))
|
8.6 ± 1.3 (n =422)
|
8.4 ± 1.5 (n =392)
|
0.196
|
0.02 (-0.32-0.06)
|
0.02 (-0.30-0.08)
|
Apgar score at 5 min (n (%))
|
8.9 ± 0.5 (n =422)
|
8.8 ± 0.7 (n =392)
|
0.112
|
0.03(-0.16-0.02)
|
0.01 (-0.15-0.02)
|
a mean ± standard deviation
Birth weight and macrosomia are adjusted for parity, age & education of the mother, and interaction between GD, BMI, and GWG.