Table 7.2GRADE summary of findings for comparison of expectant management with active treatment

Number of studiesNumber of women or averageEffectQuality
ExpectantActiveRelative

(95% CI)
Absolute

(95% CI)
Need for unplanned intervention*
1 meta-analysis of 6 studies

(Ngai et al., 2001; Nielsen & Hahlin, 1995; Nielsen et al., 1999; Shelley et al., 2005; Trinder et al., 2006; Wieringa-de Waard et al., 2002a)
238/672

(35.4%)
181/1020

(17.7%)
RR 2.28

(1.93 to 2.7)
227 more per 1000

(from 165 more to 302 more)
High
Infection (incidence up to 15 days)
1 meta-analysis of 7 studies

(Chipchase & James, 1997; Ngai et al., 2001; Nielsen & Hahlin, 1995; Nielsen et al., 1999; Shelley et al., 2005; Trinder et al., 2006; Wieringa-de Waard et al., 2002a)
17/691

(2.5%)
30/1038

(2.9%)
RR 0.82

(0.46 to 1.44)
5 fewer per 1000

(from 16 fewer to 13 more)
High
Gastrointestinal side effects (number of events)
1 study

(Ngai et al., 2001
12/87

(13.8%)
25/90

(27.8%)
RR 0.5

(0.27 to 0.92)
139 fewer per 1000

(from 22 fewer to 203 fewer)
High
Need for a blood transfusion
1 meta-analysis of 4 studies

(Ngai et al., 2001; Shelley et al., 2005; Trinder et al., 2006; Wieringa-de Waard et al., 2002a)
8/507

(1.6%)
4/911

(0.4%)
RR 3.39

(1.08 to 10.61)
10 more per 1000

(from 0 more to 42 more)
High
Duration of bleeding (days)
1 study

(Trinder et al., 2006)
Median 12

(IQR 7 to 15)

n = 398
Medical:

Median 11

(IQR 7 to 15)

n = 398

Surgical:

Median 8

(IQR 4 to 14)

n = 402
not calculable (NC)Expectant vs. medical

Median 1 higher (confidence interval NC)

P (NC)

Expectant vs. surgical

Median 4 higher (confidence interval NC)

P < 0.0001
High
1 meta-analysis of 2 studies

(Nielsen & Hahlin, 1995; Nielsen et al., 1999)
n = 179n = 134NCMD 0.28 higher

(1.64 lower to 2.20 higher)
Moderate
1 study

(Ngai et al., 2001)
Mean 15

(SD not reported [NR])

n = 29
Mean 14.6

(SD NR)

n = 30
NCMD 0.4 higher

(confidence intervals NC)

P value NR
Moderate
1 study

(Wieringa-de Waard et al., 2002a)
Median 17

(IQR 10 to 26

n = 64
Median 13

(IQR 9 to 17)

n = 58
NCMedian 4 higher

(confidence interval NC)

P = 0.04
Moderate
1 study

(Chipchase & James, 1997)
Median 4

(range 0 to 7)

n = 19
Median 2

(range 0 to 7)

n = 16
NCMedian 2 higher

(confidence interval NC)

NS (P value NR)
Moderate
Pain: duration (days)
1 study

(Nielsen & Hahlin, 1995)
Mean 1.92

(SD 1.47)

n = 103
Mean 1.69

(SD 1.46)

n = 52
NCMD 0.230 higher

(0.263 lower to 0.723 higher)

NS (P > 0.03)
Moderate
1 study

(Wieringa-de Waard et al., 2002a)
Median 14

(IQR 7 to 24)

n = 64
Median 11

(IQR 6 to 26)

n = 58
NCMedian 3 higher

(confidence interval NC)

NS (P value not reported)
Moderate
1 study

(Chipchase & James, 1997)
Median 0

(range 0 to 5)

n = 19
Median 0

(range 0 to 2)

n = 16
NCMedian 0 higher

(confidence interval NC)

NS (P value NR)
Moderate
1 study

(Shelley et al., 2005)
Median 3.0

(range 0.0 to 11.0)

n = 15
Medical:

Median 3.0

(range 0.2 to 16.0)

n = 11

Surgical:

Median 2.0

(range 0.2 to 12.0)

n = 12
NCExpectant vs. medical

Median 0 higher

(confidence interval NC)

Expectant vs. surgical

Median 1 higher (confidence interval NC)

P values NR
Moderate
Pain severity
1 study

(Nielsen et al., 1999)
Mean 62.0

(SD 30.1)

n = 62
Mean 66.1

(SD 26.3)

n = 60
NCMD 4.10 lower

(12.97 lower to 4.77 higher)

NS (P value NR)
Moderate
1 study

(Shelley et al., 2005)
Median 3

(range 1 to 7)

n = 15
Medical:

Median 3

(range 1 to 8)

n = 11

Surgical:

Median 3

(range 1 to 10)

n = 12
NCMedian difference NC

(confidence interval NC)

NS between 3 groups but P values NR
Moderate
Unplanned admissions
1 study

(Trinder et al., 2006)
196/398

(49.2%)
104/800

(13%)
RR 3.79

(3.09 to 4.65)
363 more per 1000

(from 272 more to 475 more)
High
Women's satisfaction
1 study

(Nielsen et al., 1999)
Mean 25.2

(SD 25.6)

n = 62
Mean 28.6

(SD 24.8)

n = 60
NCMD 3.40 lower

(11.32 lower to 4.52 higher)

P = 0.174
Moderate
1 study

(Chipchase & James, 1997)
19/19

(100%)
14/16

(87.5%)
RR 1.14

(0.95 to 1.38)
125 more per 1000

(44 fewer to 388 more)
Low
Anxiety
1 study

(Nielsen et al., 1996)
Mean 57.5

(SD 12.4)

n = 58
Mean 57.5

(SD 14.0 )

n = 28
NCMD 0.00 higher

(5.92 lower to 5.92 higher)

P > 0.30
Moderate
1 study

(Wieringa-de Waard et al., 2002b)
Mean/SD NR

n = 46
Mean/SD NR

n = 36
NCMD NC

(confidence interval NC)

P = 0.09
Low
1 study

(Shelley et al., 2005)
3/15

(20%)
5/22

(22.7%)
RR 0.88

(0.25 to 3.14)
27 fewer per 1000

(171 fewer to 486 more)
Low
Mental health
1 study

(Wieringa-de Waard et al., 2002b)
Mean/SD NR

n = 46
Mean/SD NR

n = 36
NCMD 7.4 in favour of expectant (confidence interval NC)

P = 0.004
Low
1 study

(Shelley et al., 2005)
Mean 37.1

(SD 13.0)

n = 15
Mean 39.3

(SD 14.2)

n = 22
NCMD 2.2 lower

(11.54 lower to 7.14 higher)
Low
Live birth rate in a subsequent pregnancy
1 study

(Smith et al., 2009)
177/224

(79.0%)
373/465

(80.2%)
RR 0.99

(0.91 to 1.07)
12 fewer per 1000

(from 74 fewer to 55 more)
Moderate
Subsequent conception rate
1 study

(Chipchase & James, 1997)
9/12

(75%)
6/9

(66.7%)
RR 1.13

(0.64 to 1.98)
83 more per 1000

(from 241 fewer to 654 more)
Low
1 study

(Blohm et al., 1997)
Cumulative conception rate: 0.7Cumulative conception rate: 0.6NCNS

(P value NR)
Low

CI confidence interval, IQR interquartile range, MD mean difference, NC not calculable, NR not reported, NS not significant, P probability, RR relative risk, SD standard deviation

*

Unplanned interventions include: surgery (including repeat surgery) due to first-line treatment failure, emergency surgery prior to allocated treatment, surgical completion on maternal request, or treatment to deal with a complication of the initial treatment

Unplanned admission is an admission to hospital during the trial that was not pre-specified in the methodology as part of the management protocol

From: 7, Management of threatened miscarriage and miscarriage

Cover of Ectopic Pregnancy and Miscarriage
Ectopic Pregnancy and Miscarriage: Diagnosis and Initial Management in Early Pregnancy of Ectopic Pregnancy and Miscarriage.
NICE Clinical Guidelines, No. 154.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG; 2012 Dec.
Copyright © 2012, National Collaborating Centre for Women's and Children's Health.

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