Scolaris Content Display Scolaris Content Display

Study flow diagram.
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Figure 1

Study flow diagram.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
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Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
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Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Comparison 1 Home uterine monitoring versus standard care ‐ primary outcomes, Outcome 1 Perinatal mortality.
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Analysis 1.1

Comparison 1 Home uterine monitoring versus standard care ‐ primary outcomes, Outcome 1 Perinatal mortality.

Comparison 1 Home uterine monitoring versus standard care ‐ primary outcomes, Outcome 2 Preterm birth < 34 weeks.
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Analysis 1.2

Comparison 1 Home uterine monitoring versus standard care ‐ primary outcomes, Outcome 2 Preterm birth < 34 weeks.

Comparison 1 Home uterine monitoring versus standard care ‐ primary outcomes, Outcome 3 Preterm birth < 34 weeks (Subgroup analysis).
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Analysis 1.3

Comparison 1 Home uterine monitoring versus standard care ‐ primary outcomes, Outcome 3 Preterm birth < 34 weeks (Subgroup analysis).

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 1 Preterm birth < 37 weeks.
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Analysis 2.1

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 1 Preterm birth < 37 weeks.

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 2 Preterm birth < 37 weeks (Subgroup analysis).
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Analysis 2.2

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 2 Preterm birth < 37 weeks (Subgroup analysis).

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 3 Preterm birth < 32 weeks.
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Analysis 2.3

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 3 Preterm birth < 32 weeks.

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 4 Use of antenatal corticosteroids.
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Analysis 2.4

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 4 Use of antenatal corticosteroids.

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 5 Respiratory distress syndrome.
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Analysis 2.5

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 5 Respiratory distress syndrome.

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 6 Use of mechanical ventilation.
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Analysis 2.6

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 6 Use of mechanical ventilation.

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 7 Admission to neonatal intensive care unit.
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Analysis 2.7

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 7 Admission to neonatal intensive care unit.

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 8 Mode of delivery.
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Analysis 2.8

Comparison 2 Home uterine monitoring versus standard care (secondary outcomes ‐ infant), Outcome 8 Mode of delivery.

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 1 Number of antenatal visits (unscheduled).
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Analysis 3.1

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 1 Number of antenatal visits (unscheduled).

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 2 Number of antenatal hospital admissions.
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Analysis 3.2

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 2 Number of antenatal hospital admissions.

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 3 Number of antenatal visits (unscheduled) (Subgroup analysis).
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Analysis 3.3

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 3 Number of antenatal visits (unscheduled) (Subgroup analysis).

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 4 Use of tocolysis.
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Analysis 3.4

Comparison 3 Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal), Outcome 4 Use of tocolysis.

Summary of findings for the main comparison. Home uterine monitoring for preventing preterm birth

Home uterine monitoring for preventing preterm birth

Patient or population: women undergoing home monitoring for preventing preterm birth versus women receiving standard care
Settings: trials took place in the USA and France
Intervention: home uterine monitoring

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Home uterine monitoring

Perinatal mortality

Study population

RR 1.22
(0.86 to 1.72)

2589
(2 studies)

⊕⊕⊝⊝
low1,2

46 per 1000

56 per 1000
(39 to 79)

Preterm birth less than 34 weeks' gestation

Study population

RR 0.78
(0.62 to 0.99)

1596
(3 studies)

⊕⊕⊕⊕
high

Sensitivity analysis included 1 study at low risk of bias (1292 women) and did not show any difference in results

166 per 1000

130 per 1000
(103 to 165)

Antenatal hospital admissions

Study population

RR 0.91
(0.74 to 1.11)

1494
(3 studies)

⊕⊕⊝⊝
low2,3

186 per 1000

169 per 1000
(137 to 206)

Preterm birth less than 37 weeks' gestation

Study population

RR 0.85
(0.72 to 1.01)

4834
(8 studies)

⊕⊝⊝⊝
very low2,4,5

364 per 1000

310 per 1000
(262 to 368)

Admission to NICU

Study population

RR 0.77
(0.62 to 0.96)

2367
(5 studies)

⊕⊕⊕⊝
moderate3

Evidence not downgraded for moderate heterogeneity (I² = 32%)

290 per 1000

223 per 1000
(180 to 278)

Number of unscheduled antenatal visits

The mean number of days ranged across control groups from approximately 1 to 2 days

The mean number of days in the monitored group was approximately half a day higher

MD 0.48 (0.31 to 0.64)

1994
(2 studies)

⊕⊕⊕⊝
moderate1

Variation in protocol and healthcare delivery structures make it difficult to generalise from 1 large study contributing 65% of the weight for this outcome

Use of tocolysis

Study population

RR 1.21
(1.01 to 1.45)

4316
(7 studies)

⊕⊕⊝⊝
low4,6

This outcome may no longer be useful, due to changes in clinical practice. Sensitivity analysis including only 3 studies at low risk of bias (3749 women) did not show any clear difference in results.

188 per 1000

228 per 1000
(190 to 273)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; MD: mean difference; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: we are very uncertain about the estimate.

1All studies contributing data with design limitations (‐1).
2Wide confidence interval crossing the line of no effect (‐1).
3Most studies with design limitations (‐1). Outcome not blinded in 2 studies.
4Most studies with design limitations (‐1).
5Statistical heterogeneity (I2 = 68%) (‐1).
6Statistical heterogeneity (I2 = 62%) (‐1).

Figures and Tables -
Summary of findings for the main comparison. Home uterine monitoring for preventing preterm birth
Table 1. Methodological quality of trials

Methodological item

Adequate

Inadequate

Generation of random sequence

Computer‐generated sequence, random‐number tables, lot drawing, coin‐tossing, shuffling cards, throwing dice

Case number, date of birth, date of admission, alternation

Concealment of allocation

Central randomisation, coded drug boxes, sequentially‐sealed opaque envelopes

Open allocation sequence, any procedure based on inadequate generation

Figures and Tables -
Table 1. Methodological quality of trials
Comparison 1. Home uterine monitoring versus standard care ‐ primary outcomes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Perinatal mortality Show forest plot

2

2589

Risk Ratio (M‐H, Fixed, 95% CI)

1.22 [0.86, 1.72]

2 Preterm birth < 34 weeks Show forest plot

3

1596

Risk Ratio (M‐H, Fixed, 95% CI)

0.78 [0.62, 0.99]

3 Preterm birth < 34 weeks (Subgroup analysis) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 Singleton gestations

1

138

Risk Ratio (M‐H, Fixed, 95% CI)

1.12 [0.55, 2.27]

3.2 Twin gestations

1

109

Risk Ratio (M‐H, Fixed, 95% CI)

0.55 [0.26, 1.17]

Figures and Tables -
Comparison 1. Home uterine monitoring versus standard care ‐ primary outcomes
Comparison 2. Home uterine monitoring versus standard care (secondary outcomes ‐ infant)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Preterm birth < 37 weeks Show forest plot

8

4834

Risk Ratio (M‐H, Random, 95% CI)

0.85 [0.72, 1.01]

2 Preterm birth < 37 weeks (Subgroup analysis) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Singleton gestations

1

2422

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.62, 1.45]

2.2 Twin gestations

1

844

Risk Ratio (M‐H, Fixed, 95% CI)

0.96 [0.71, 1.30]

3 Preterm birth < 32 weeks Show forest plot

3

2550

Risk Ratio (M‐H, Random, 95% CI)

0.76 [0.31, 1.85]

4 Use of antenatal corticosteroids Show forest plot

1

162

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.82, 1.25]

5 Respiratory distress syndrome Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

5.1 Singleton gestations

1

38

Risk Ratio (M‐H, Fixed, 95% CI)

1.25 [0.40, 3.95]

5.2 Twin gestations

1

86

Risk Ratio (M‐H, Fixed, 95% CI)

0.38 [0.13, 1.12]

6 Use of mechanical ventilation Show forest plot

2

539

Risk Ratio (M‐H, Random, 95% CI)

0.31 [0.04, 2.38]

7 Admission to neonatal intensive care unit Show forest plot

5

2367

Risk Ratio (M‐H, Random, 95% CI)

0.77 [0.62, 0.96]

8 Mode of delivery Show forest plot

1

162

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.36, 2.66]

Figures and Tables -
Comparison 2. Home uterine monitoring versus standard care (secondary outcomes ‐ infant)
Comparison 3. Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of antenatal visits (unscheduled) Show forest plot

2

1994

Mean Difference (IV, Fixed, 95% CI)

0.48 [0.31, 0.64]

2 Number of antenatal hospital admissions Show forest plot

3

1494

Risk Ratio (M‐H, Fixed, 95% CI)

0.91 [0.74, 1.11]

3 Number of antenatal visits (unscheduled) (Subgroup analysis) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

3.1 Singleton gestations

1

1060

Mean Difference (IV, Fixed, 95% CI)

0.40 [0.15, 0.65]

3.2 Twin gestations

1

564

Mean Difference (IV, Fixed, 95% CI)

0.60 [0.24, 0.96]

4 Use of tocolysis Show forest plot

7

4316

Risk Ratio (M‐H, Random, 95% CI)

1.21 [1.01, 1.45]

Figures and Tables -
Comparison 3. Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal)