Table 1.
Characteristics of the included studies.
| Study | Trial characteristics | Population characteristics | Intervention characteristics | Intervention and comparison groups | Outcomes and results | ||
|---|---|---|---|---|---|---|---|
| Dawe et al. and Okesene-Gafa et al. (33, 35) New Zealand Funding: Research grants, Industry |
Parallel RCT Enrollment: Apr 2015–Jun 2017 Setting: Community |
N = 230 Clinical characteristics: Pregnant women BMI ≥30 kg/m2 Mean age (SD) (yr): 29.7 (5.4). Intervention: 30.0 (5.5); Placebo: 29.39 (5.3) Gestational age: 12–17 (+6 days) wks Ethnicity: Maori (20%), Pasifika (48%), Asian (9%), Latin American/African (2%), European (21%) SES characteristics: Income: Highest deprivation quintile (63%) Education: Incomplete high school (28%), complete high school (15%), diploma (20%); tertiary (37%) |
Intervention: Probiotic (capsules) Lactobacillus rhamnosus GG and Bifidobacterium lactis BB. 12 6.5 × 109 cfu. 1 dose per day Control: Placebo capsules (microcrystalline cellulose and dextrose anhydrate) Period of initiation: End of 1st trimester (12–17 + 6 d wks) Duration: From 12–17 (+6 days) wks−36 wks of pregnancy |
Intervention N randomized = 115 N analyzed = 88 N dropouts = 27 Control N randomized = 115 N analyzed = 76 N dropouts = 39 |
Period of outcomes assessment: 36 wks gestation | ||
| Depression: EPDS depression scores | |||||||
| Mean score, SD | |||||||
| Intervention (n = 88) | 7.2 (3.8) | ||||||
| Control (n = 76) | 6.7 (4.6) | ||||||
| Depression (% scoring at cut-off ≥13 for depression) | |||||||
| Yes | No | ||||||
| Intervention (n = 88) | 8 (9%) | 80 (91%) | |||||
| Control (n = 76) | 8 (11%) | 68 (89%) | |||||
| Anxiety: STAI-6 anxiety scores | |||||||
| Mean score, SD | |||||||
| Intervention (n = 88) | 31.9 (10.2) | ||||||
| Control (n = 76) | 32.8 (10.3) | ||||||
| Anxiety (% scoring at or above >15 cut-off in STAI-6) (35) | |||||||
| Yes | No | ||||||
| Intervention (n = 87) | 6 (6.9%) | 81 (93.1%) | |||||
| Control (n = 77) | 4 (5.2%) | 73 (94.8%) | |||||
| Mental health: SF-36 Mental Health subscale scores | |||||||
| Mean score, SD | |||||||
| Intervention (n = 88) | 48.6 (8.5) | ||||||
| Control (n = 76) | 48.3 (9.8) | ||||||
| Mirghafourvand et al. (34) Iran Funding: University |
Parallel RCT Enrollment: Dec 2014–Jul 2015 Setting: Health care centers |
N = 60 Clinical characteristics: Pregnant women; Constipation (ROME III criteria Mean age (SD) (yr): 28.6 (NR) Intervention: 28.5 (NR) Control: 28.77 (NR) Gestational age: 24–28 wks Ethnicity: NR |
Intervention: Probiotic (yogurt) Bifidobacterium lactis and Lactobacillus acidophilus 4.8 × 1010 cfu. 300 gr 3x/day. Control: Conventional yogurt. 300 gr 3x/day. Period of initiation: End of 2nd trimester (24–28 wks) Duration: 4 wks |
Intervention N randomized = 30 N analyzed = 29 N dropouts = 1 Control N randomized = 30 N analyzed = 28 N dropouts = 2 |
Period of outcomes assessment: 30–34 wks gestation Mental health: SF-36 Mental Health subscale scores | ||
| Mean score, SD | |||||||
| Intervention (n = 30) | 60.1 (10.7) | ||||||
| Control (n = 30) | 55.7 (16.1) | ||||||
|
SES characteristics: Income: Favorable (10%); partly favorable (76.7%), unfavorable (13.3%) Education: Primary (23.3%), secondary (10%), diploma (45%), university (21.7%) |
|||||||
| Slykerman et al. (36) New Zealand Funding: Research grants, Industry |
Parallel RCT Enrollment: Dec 2012–Nov 2014 Setting: Community |
N = 423 Clinical characteristics: Pregnant women; healthy Mean age, SD (yr): 33.5 (4.3) Intervention: 33.5 (4.2) Control: 33.7 (4.4) Gestational age: 14–16 wks Ethnicity: Maori (12.9%); Pacific (2.1%); Asian (7.1%); European (77.6%); Other (0.3%) SES characteristics: Income: 0–49k (6.6%); 50–99k (32.1%), 100–149k (35.5%); 150+k (25.8%) Education: School (12.6%), post school (11.3%), university (76.1%) |
Intervention: Probiotic (capsules) Lactobacillus rhamnosus HN001; Capsules (6 × 109 cfu/day) Control: Placebo capsules (corn-derived maltodextrin). Period of initiation: Start of 2nd trimester (14–16 wks) Duration: From 14–16 wks to 6 mo postpartum |
Intervention N randomized = 212 N analyzed = 193 N dropouts = 19 Control N randomized = 211 N analyzed = 187 N dropouts = 24 |
Period of outcomes assessment: 12 mo postpartum Depression: EPDS depression scores. | ||
| Mean score, SD | |||||||
| Intervention (n = 194) | 7.7 (5.4) | ||||||
| Control (n = 187) | 9.0 (6.0) | ||||||
| Depression (% scoring at or above >12 cut-off in EPDS) | |||||||
| Yes | No | ||||||
| Intervention (n = 194) | 32 (16.5%) | 162 (83.5%) | |||||
| Control (n = 187) | 44 (23.5%) | 143 (76.5%) | |||||
| Anxiety: STAI-6 anxiety scores | |||||||
| Mean score, SD | |||||||
| Intervention (n = 192) | 12.0 (4.0) | ||||||
| Control (n = 187) | 13.0 (4.3) | ||||||
| Anxiety (% scoring at or above >15 cut-off in STAI-6) | |||||||
| Yes | No | ||||||
| Intervention (n = 192) | 30 (15.6%) | 162 (84.4%) | |||||
| Control (n = 187) | 55 (29.4%) | 132 (70.6%) | |||||
BMI, body mass index; cfu, colony forming units; EPDS, Edinburgh Postnatal Depression Scale; gr, grams; mo, months; NR, not reported; RCT, randomized controlled trial; SD, standard deviation; SES, socioeconomic status; STAI-6, State Trait Anxiety Inventory 6 item version; wk, weeks; yr, years.