Home uterine monitoring for detecting preterm labour

Christine Urquhart; Rosemary Currell; Francoise Harlow; Liz Callow

doi:10.1002/14651858.CD006172.pub4

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Figure 1

Study flow diagram.

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Figure 2

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

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Figure 3

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

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Analysis 1.1

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

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Analysis 1.2

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

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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).

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Analysis 2.1

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

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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).

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Analysis 2.3

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

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Analysis 2.4

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

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Analysis 2.5

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

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Analysis 2.6

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

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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.

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Analysis 2.8

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

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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).

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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.

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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).

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Analysis 3.4

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

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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)	⊕⊕⊝⊝ low^1,2
	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)	⊕⊕⊝⊝ low^2,3
	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 low^2,4,5
	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)	⊕⊕⊝⊝ low^4,6	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).

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

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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

Table 1. Methodological quality of trials

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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]

Comparison 1. Home uterine monitoring versus standard care ‐ primary outcomes

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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]

Comparison 2. Home uterine monitoring versus standard care (secondary outcomes ‐ infant)

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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]

Comparison 3. Home uterine monitoring versus standard care (secondary outcomes ‐ prenatal)

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