Table 2 Study characteristics and perinatal, maternaland adherence outcomes

Baarnes et al., 2016

Denmark (HIC) [40]

Pregnant women with asthma

Before and after

N = 114

Verbal and written information about asthma treatment, importance of adherence with medication, at each appointment.

Review every 4 weeks during pregnancy and 3 months after birth.

Pre-pregnancy or earlier gestation (at enrolment)

Control of asthma- per GINA guidelines Before measurement: enrolment; After measurement: last visit before birth.

Rated well controlled: I: 88% vs C: 66% (no inferential statistics reported).

Objective Adherence: MPR: pre-pregnancy to during pregnancy

All women: MPR: I: 46% (s.d. = 31) C: 28% (s.d. = 25; (p < .0001).

Women who filled > 1 prescription: MPR pre-pregnancy 34% (s.d. = 24), pregnancy 56% (s.d. = 25), (p < .0001).

Asthma control: (enrolment to last visit before birth).

Improvement in FEV₁ (p < .05), Reduction in FeNO (p < .001)

SRA: rated by woman as good, moderate, low (enrolment to last visit).

‘Good’ adherence; I: 73%, C: 52%, (p > .001)

Carter et al., 2020 USA (HIC) [41]

Pregnant women with Type 2 (48.7%) and gestational diabetes (GDM) diagnosed < 32 weeks (51.3%)

Pilot RCT

N = 78 (I = 48;, C = 30)

4 Group education sessions: Self-assessed + recorded blood pressure, weight blood glucose. Activities: snacks, self-reflection activities, crafts, pregnancy or behavioural health stations + group activities about diabetes, pregnancy, tailored behavioural health topics. Seen individually as needed.

Individual care: prenatal care in diabetes clinic every 2 weeks or more at provider discretion per national guideline. Included routine screening, review of blood sugar logs, medication titration.

Perinatal outcomes

IoL: I:52.5%, C:42.1%, p = 0.36;

C-section: I: 50%, C: 52.6%, p = 0.82;

GAB: I: 37.8 (s.d. = 3.1), C: 37.5 (s.d. = 2.2), p = 0.75;

PTB I: 20%, C: 23.7, p = 0.69;

BW: I:3256.1 g (s.d. = 817.5), C:3176.7 g (s.d. = 644.2), p = 0.64;

SmGA: I:5.0%, C:2.6%, p > 0.99;

LGA: I: 42.5%, C:28.9%, p = 0.21;

DYS: I:12.5%, C:2.6%, p = 0.20;

Neonatal polycythemia: I: 10%, C: 15.8%, p = 0.51;

Hypoglycaemia: I: 27.5%, C: 26.3%, p = 0.91;

Treatment for hypoglycaemia: I: 17.5%, C: 15.8%, p = 0.84;

Respiratory distress syndrome: I: 12.5%, C: 21.1%, p = 0.37;

NICU admission> 24 hrs: I: 27.5%, C: 26.3%, p = 0.91

SRA: Summary of self-care diabetes activities(no. of days taking recommended medication in past week)

I = 6.4 days (s.d = 1.5); C: 5.7 days (s.d. = 2.4) p = 0.48

Maternal: HbA1c (type 2 group only), Hypertensive disorders (both groups). % and mmol/mol

HbA1c: I: 6.3% (s.d. = 0.7%) (44.9 mmol/mol; s.d. = 7.8 mmol/mo) l, C: 6.8% (s.d. = 0.9%) (50.7 mmol/mol, s.d. = 10.0 mmol/mol), P = 0.09

Hypertensive disorder: I: 40% C: 34.2%, p = 0.34;

De Lima et al., 2016

Netherlands (HIC) [42]

Women planning pregnancy within 2 years and pregnant women with Inflammatory Bowel Disease

Comparative (non-randomised)

N = 317

(I = 155; C = 162)

Pre-conception counselling (PCC) in specialist clinic: discussed guidelines, letter with advice summarised. Followed up every 3 months until conception, 2 months during pregnancy (2-weekly if active disease).

Attending specialist clinic during pregnancy only. (Follow-up every 2 months during pregnancy only, 2 weekly if active disease)

Perinatal outcomes

LBW: I: I7.2% vs C: 12.6% (aOR 0.08; 95% CI, 0.01–0.48) p < .006

BW: I 3373 g(IQR295–3679), C: 3363 g (IQR 2829–3630) p=.52

SmGA: I: 31%, C: 9.4% (aOR 0.22; 95% CI, 0.05–1.00), p=.05

GAB: I: 38.4wks (IQR 34.0–40.0), C: 38.0 wks (36.1–39.5), p = .50

LB: I: 75.2%, C: 78.4% (aOR 0.79; 95% CI 0.45–1.38), p=.40

PTB: I: 13.4%, C: 7.9% (aOR 1.74; 95% CI 0.73–4.6), p=.22

SA: I: 20.2%, C: 19.1% (aOR 1.10; 95%CI 0.61–2.00), p=.75

CA: I: 3.1%, C: 4.7% (aOR 1.74; 95% CI 0.73–4.6), p=.91

SRA: ‘Correct adherence’- measure used not reported

Not adherent: I: 2.6%, C:13.6%; Adherent: I: 97.4%, C: 86.4% (aOR, 5.69; 95% CI 1.88–17.27, p < .002).

Maternal disease activity: (HBI; SCCAI; OR fecal calprotectin >200μg/g).

Disease activity: I: 18.1%, vs C:34.0%; No disease activity: I: 58.1%, C: 63.0% (aOR, 0.51; 95% CI, 0.28–0.95, p = .05)

Flannagan et al., 2020 Australia (HIC) [43]

Pregnant women and women planning to conceive with IBD (50% pregnant; median gestation 12 weeks)

Before and after

N = 81

Single-session gastroenterologist led in person/ telephone using pro-forma for evidence based advice, structured discussion relating to IBD and pregnancy + information tailored to patient concerns.

Before attending intervention (timepoint not stated)

Maternal disease activity: IBD questionnaire (bowel symptoms and systemic symptoms subscales)

Bowel symptoms I: 5.5 (IQR 4.9–6.1), C: 6 (IQR 5.5–6.5), P < .001

Systemic symptoms: I: 4.4 (IQR 3.4–5), C: 4.8 (IQR 4.2–5.6), p < .01

SRA: medication adherence scale, (not reported).

80% doses: I:93%, C: 89%;

50–80% doses: I: 5%, C:4%;

0–49% doses I: 7%, C: 1%; p = 0.18

Karunia et al., 2019 Indonesia (LMIC) [44]

Pregnant women with high risk for pre-eclampsia (PE) screened 11 + 0 to 13 + 6 weeks of pregnancy

Before and after

N = 12

Educational booklet and verbal information given twice 28 days apart (visit 1 and 2): definitions, signs, symptoms and effects of PE, prevention with low dose aspirin, dosing and administration, info about benefits of aspirin for mother and foetus, importance of adherence.

After first intervention administration

Objective: Pill count (pills remaining from 30 given) at 28 days post second intervention administration

I: 95.8% (third visit), C: 89.8% (second visit), p = 0.011

Kim et al., 2019

Malawi (LIC) [45]

Pregnant women with HIV

Pilot RCT

N = 30

(I = 146

C = 160)

VITAL Start (VS): Video and counselling intervention, based on IMB Model: information about ART on body, managing side effects, adherence strategies.

Health care worker delivered 1 hr. group lecture based on Malawi National standard pre-ART counselling flipchart.

Objective adherence: Electronic pill count derived from pharmacy records at 1 month

Pill count > 90–100%: I: 65.1%, C: 59.4%, p = .31.

SRA: missed dose

Missed dose last 7 days: I: 13.6%, C:26.8%, p < .02.

Missed dose last 30 days: I: 29.9% C: 15.3%, p < .02.

Krishnakumar et al., 2020

India

(LIC) [46]

Pregnant women with gestational diabetes mellitus using metformin or insulin (44 using metformin, 37 insulin)

Before and after

N = 81

Patient education leaflet and verbal education for 30 minutes. Two sessions. Referred to as continuous.

Pre-intervention measurement (timepoint not stated)

Maternal:

Glycaemic Control- Fasting and post-prandial glucose (mg/dL) pre-intervention to 2/3 months follow-up.

Fasting: Insulin group: I: 94.59 (s.d.5.77), C: 103.81 (s.d. = 7.98), p = .0001; Metformin group: I: 94.84 (s.d. = 6.18), C: 105.16 (s.d. = 15.16),, p < .0001;

Postprandial blood glucose: Insulin group: I: 116.05 (s.d. = 6.01), C:128.30 (s.d. = 7.26), p < .0001; Metformin group: I: 117.86 (s.d. = 6.54), C: 130.23 (s.d. = 16.83), p < .0001

SRA: Morisky medication adherence scale

MMAS (whole sample, n = 81) I: 6.38 (s.d. = 0.70 C: 5.6 (s.d. = 1.15), p < .0001;

Metformin group: I 6.43 (s.d.0.36), C: 4.84 (s.d. = 1.14)p < .0001,

Insulin (n = 37): I: 6.62 (s.d. = 0.53),C: 4.77 (s.d. = 1.17), p < .0001

Murphy et al., 2005

Australia (HIC) [47]

Pregnant women with asthma

Before and after

N = 177

Asthma education programme +/− action plan, offered two visits, with additional visits where required.

First visit (approx. 20 weeks gestation).

Perinatal outcomes: (comparing women +/− action plan, n = 46). Before measurement: first visit or 20wks gestation. After measurement: 33 wks gestation.

Lower BW in women without additional action plan (no data reported; p < .005).

SRA: ICS adherence in the previous week at 20 vs 33 weeks. Severe asthma (n = 61)

All participants: Adherence > 80% doses. I: 40%, C: 21% (p < .006)

Severe asthma: Decreased non-adherence between measurements points (exact values not reported; p = 0.014)

Lung function: Measured 20 weeks gestation vs.33 weeks in women with mild (max n = 108), moderate (max n = 42) and severe asthma (max n = 61)

Mild and moderate asthma: No change between visits (p > .05 for all): FEV₁L; FEV₁ (% pred); FVC-L; FEC₁:FVC; night symptoms; morning symptoms; activity limitation; RMU: d/w, t/d, t/w.

Severe asthma: No change between visits (p < .05) for FEV₁L; FEV₁ (% pred); FVC-L; FEC₁:FVC; morning symptoms; activity limitation.^a

Night symptoms: I: 0 (IQR0–3), C: 5 (IQR 2–7), p < .05

RMU-d/w: I: 7 (IQR 2–7) C: 7 (IQR 7–7), p < .05

RMU-t/d: I: 2 (IQR 1–3) C: 3 (IQR 2–5), p < .05

RMU-t/w: I: 7(IQR 3–14), C: 21 (IQR 7–35), p < .05

Pintye et al., 2020

Kenya

(LMIC) [48]

Pregnant women with HIV

Comparative (non-randomised)

N = 356 (I = 190; C = 166)

2-way SMS message communication (mWACH-PrEP); weekly automated messages informed by behaviour change theory + opportunity to communicate with a nurse via SMS

Women starting PrEP in preceding month before implementation of mWACH-PrEP

SRA: Self-reported adherence- number of missed doses in the past month in those returning, (high = < 1 missed pill/week)

High PrEP adherence I: 73% C: 55% (aRR = 1.35; 95% CI = 1.28,1.41; p < .001).

Objective: PrEP refills; PrEP continuation (attendance + PrEP Refill)

I: 43%, C: 22%; aRR = 1.75; 95% CI 1.21, 2.55; p = .003

Potter et al., 2019

USA (HIC) [49]

Pregnant women with HIV

Comparative (non-randomised)

N = 117

(I = 14

C = 103)

Centering pregnancy; group sessions on ARVs in pregnancy, importance of adherence and impact, preventing transmission. (10 × 2 hours)

Standard care

Maternal viral load near birth (< 200 copies/mL).

I vs C: (aOR 7.0; 95% CI 0.6–81.51, p.13)

Perinatal outcomes

BM [aOR 0.29; 95% CI 0.07–1.10], APGAR at 5 mins [p > .99; OR not reported], GAB [aOR 0.29, 95% CI, 0.07–1.10], BW [p = .51, OR not reported], Newborn HIV status: [p = .73, OR not reported].

Psaros et al., 2022

South Africa

(UMIC) [50]

Pregnant women with HIV

RCT

N = 23

Individual-targeted combined depression and adherence intervention: problem solving. Therapy and LifeSteps for PMTCT.

Usual care

SRA: Adherence composite score 1 month adherence, 3 month follow up.

No main effect or interaction between intervention and timepoint: BL: I: 85.3 (s.d. = 12.9), C: 79.0 (s.d. = 14.4), Post-test: I: 92.8 (s.d. = 8.7), C: 77.8 (s.d. = 15.4),

3 month follow up: I: 88.7 (s.d. = 9.3), C: 89.2 (s.d. = 5.9).

Objective: Medication event monitoring system (bottle with digitised cap)

No main effect or interaction between intervention and time point. BL: I: 99.4 (s.d. = 2.2), C: 92.9 (s.d. = 14.3),

Post test: I: 98.6 (s.d. = 3.0), C: 100 (s.d. = 0);

3 month follow upFollow up: I: 92.8 (s.d. = 6.4), C: 85.7 (s.d. = n/a)

Weiss et al.

2014

South Africa

(UMIC) [51]

Pregnant women with HIV

Pilot RCT (cluster randomised trial)

N = 478

(I = 238, C = 240)

PartnerPlus: comprehensive couples-based PMTCT programme: 4, weekly sessions included CBT to improve adherence to treatment. Informed by IMB Model.

Enhanced standard care: standard antenatal care + PMTCT, health-related videos, without PartnerPlus intervention.

Perinatal outcomes: LB in subset (n = 82)

LB: I: 81.1%, vs C: 86.0%

(p = .49)

Objective adherence: blood sample assessing ARV presence in mother (n = 24) and infant (n = 25)

No difference between groups for ARV presence in blood

Mother I: 75%, C: 50% (p = .19)

Infant I: 92%, C: 75% (p = .32)

Yotebieng et al., 2016

D.R. Congo (LIC) [52]

Pregnant women diagnosed with HIV, seropositive.

newly diagnosed, < 32 weeks pregnant

RCT

N = 326 (I = 171, Cl = 155)

Compensation ($5, plus $1 increment at each subsequent visit) conditional on attending scheduled clinic visits and accepting offered PMTCT services.

Standard care

Maternal viral load at 6 weeks postpartum (detection: 40 copies/mL)

Detectable I: 33.9% vs C: 30.3%

[aRisk difference = −.01, 95% CI −0.10-.08).

Objective adherence: pill count assessed and classified as 100% adherent.

Intervention: adherent I: 69.9%, C: 68.1%; Not adherent I: 30.1%, C: 31.9% [aRisk difference = 0.03, 95%CI − 0.05- 0.12]