Preoperative ripening of the cervix before operative hysteroscopy

Haya Al‐Fozan; Belal Firwana; Hanan Al Kadri; Samar Hassan; Togas Tulandi

doi:10.1002/14651858.CD005998.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 4

Forest plot of comparison: 1 Misoprostol versus placebo or no treatment, outcome: 1.1 Ease of dilatation: need for mechanical dilatation.

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Figure 5

Forest plot of comparison: 1 Misoprostol versus placebo or no treatment, outcome: 1.2 Intraoperative complications.

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Figure 6

Funnel plot of comparison: 1 Misoprostol versus placebo or no treatment, outcome: 1.2 Intraoperative complications.

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Analysis 1.1

Comparison 1 Misoprostol versus placebo or no treatment, Outcome 1 Ease of dilatation: need for mechanical dilatation.

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Analysis 1.2

Comparison 1 Misoprostol versus placebo or no treatment, Outcome 2 Intraoperative complications.

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Analysis 1.3

Comparison 1 Misoprostol versus placebo or no treatment, Outcome 3 Specific intraoperative complications.

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Analysis 1.4

Comparison 1 Misoprostol versus placebo or no treatment, Outcome 4 Time required to dilate the cervix (sec.).

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Analysis 1.5

Comparison 1 Misoprostol versus placebo or no treatment, Outcome 5 Preoperative pain score.

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Analysis 1.6

Comparison 1 Misoprostol versus placebo or no treatment, Outcome 6 Cervical width (dilator size in mm).

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Analysis 1.7

Comparison 1 Misoprostol versus placebo or no treatment, Outcome 7 Failure to dilate the cervix.

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Analysis 1.8

Comparison 1 Misoprostol versus placebo or no treatment, Outcome 8 Side effects.

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Analysis 1.9

Comparison 1 Misoprostol versus placebo or no treatment, Outcome 9 Types of side effects.

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Analysis 1.10

Comparison 1 Misoprostol versus placebo or no treatment, Outcome 10 Duration of operation( min..).

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Analysis 2.1

Comparison 2 Misoprostol versus dinoprostone, Outcome 1 Ease of dilatation: need for mechanical dilatation.

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Analysis 2.2

Comparison 2 Misoprostol versus dinoprostone, Outcome 2 Intraoperative complications.

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Analysis 2.3

Comparison 2 Misoprostol versus dinoprostone, Outcome 3 Types of side effects.

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Analysis 2.4

Comparison 2 Misoprostol versus dinoprostone, Outcome 4 Time required to dilate the cervix (sec.).

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Analysis 2.5

Comparison 2 Misoprostol versus dinoprostone, Outcome 5 Cervical width (dilator size in mm).

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Analysis 2.6

Comparison 2 Misoprostol versus dinoprostone, Outcome 6 Duration of operative hysteroscopy (min.).

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Analysis 3.1

Comparison 3 Misoprostol versus osmotic dilator, Outcome 1 Ease of dilatation: need for mechanical dilatation.

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Analysis 3.2

Comparison 3 Misoprostol versus osmotic dilator, Outcome 2 Intraoperative complications.

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Analysis 3.3

Comparison 3 Misoprostol versus osmotic dilator, Outcome 3 Time required to dilate the cervix (sec.).

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Analysis 3.4

Comparison 3 Misoprostol versus osmotic dilator, Outcome 4 Cervical width (dilator size in mm).

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Summary of findings for the main comparison. Misoprostol compared to placebo or no treatment before operative hysteroscopy

Misoprostol compared to placebo or no treatment for women undergoing hysteroscopy
Population: Pre and post menopausal women Settings: Operative hysteroscopy Intervention: Preoperative misoprostol Comparison: Placebo or no treatment
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo or no treatment	Misoprostol
Ease of dilatation: need for mechanical dilatation	797 per 1000	239 per 1000 (136 to 386)5 to 23 per 1000	OR 0.08 (0.04 to 0.16)	441 (5 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Intraoperative complications	29 per 1000	11 per 1000 (5 to 23)	OR 0.37 (0.18 to 0.77)	901 (12 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Specific intraoperative complications ‐ Cervical laceration/tear	25 per 1000	6 per 1000 (3 to 14)	OR 0.25 (0.11 to 0.57)	669 (9 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Specific intraoperative complications ‐ False track	40 per 1000	14 per 1000 (5 to 39)	OR 0.34 (0.12 to 0.97)	560 (7 RCTs)	⊕⊕⊕⊝ MODERATE ¹
Specific intraoperative complications ‐ Uterine perforation	29 per 1000	13 per 1000 (4 to 40)	OR 0.42 (0.13 to 1.38)	455 (7 RCTs)	⊕⊕⊝⊝ LOW ^1,2
Specific intraoperative complications ‐ Uterine bleeding	60 per 1000	32 per 1000 (6 to 137)	OR 0.51 (0.10 to 2.49)	340 (4 RCTs)	⊕⊕⊝⊝ LOW ^1,2
Side effects	18 per 1000	112 per 1000 (48 to 241)	OR 2.59 (1.15 to 5.79)	272 (4 RCTs)	⊕⊕⊕⊝ MODERATE ¹
The basis for the assumed risk* is the median control group risk across studies. 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; OR odds 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.
¹Inadequate reporting of methodology by all or most of the studies ²Imprecision: low event rates and wide confidence intervals compatible with no effect or with meaningful benefit from misoprostol

Summary of findings for the main comparison. Misoprostol compared to placebo or no treatment before operative hysteroscopy

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Summary of findings 2. Misoprostol compared to dinoprostone before operative hysteroscopy

Misoprostol compared to dinoprostone for health problem or population
Population: Pre and post menopausal women Settings: Operative hysteroscopy Intervention: Preoperative misoprostol Comparison: Preoperative dinoprostone
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Dinoprostone	Misoprostol
Ease of dilatation: need for mechanical dilatation	804 per 1000	704 per 1000 (582 to 801)	OR 0.58 (0.34 to 0.98)	310 (1 RCT)	⊕⊕⊝⊝ LOW ^1,2
Intraoperative complications	114 per 1000	40 per 1000 (15 to 96)	OR 0.32 (0.12 to 0.83)	310 (1 RCT)	⊕⊕⊝⊝ LOW ^1,2
Side effects	Total side effects not reported. Some specific side effects (abdominal pain, vaginal bleeding, diarrhoea and perception of raised temperature) were more common in the misoprostol group. All side effects were mild.				⊕⊕⊝⊝ LOW ^1,3
The basis for the assumed risk* is the median control group risk across studies. 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; OR odds 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.
¹Inadequate description of study methods, high risk of attrition bias ²Imprecision: wide confidence intervals compatible with meaningful benefit from misoprostol or with little or no meaningful benefit ³Imprecision: wide confidence intervals compatible with harm from misoprostol or no clinically meaningful effect

Summary of findings 2. Misoprostol compared to dinoprostone before operative hysteroscopy

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Summary of findings 3. Misoprostol compared to osmotic dilator before operative hysteroscopy

Misoprostol compared to osmotic dilator for health problem or population
Population: Pre and post menopausal women Settings: Operative hysteroscopy Intervention: Preoperative misoprostol Comparison: Preoperative osmotic dilator
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Osmotic dilator	Misoprostol
Ease of dilatation: need for mechanical dilatation	283 per 1000	702 per 1000 (507 to 843)	OR 5.96 (2.61 to 13.59)	110 (1 RCT)	⊕⊕⊝⊝ LOW ^1,2
Intraoperative complications	0 per 1000	0 per 1000 (0 to 0)	OR 5.14 (0.24 to 109.01)	354 (3 RCTs)	⊕⊕⊝⊝ LOW ^3,4	Only two events altogether. No events in two RCTs
The basis for the assumed risk* is the median control group risk across studies. 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; OR odds 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.
¹Risk of attrition bias unclear; unclear whether outcome assessment was blinded ²Imprecision: single small study with total of 55 events ³One of studies does not adequately describe methods, unclear whether outcome assessment blinded ⁴Imprecision: only 2 events

Summary of findings 3. Misoprostol compared to osmotic dilator before operative hysteroscopy

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Comparison 1. Misoprostol versus placebo or no treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Ease of dilatation: need for mechanical dilatation Show forest plot	5	441	Odds Ratio (M‐H, Fixed, 95% CI)	0.08 [0.04, 0.16]

1.1 Premenopausal women	4	335	Odds Ratio (M‐H, Fixed, 95% CI)	0.10 [0.05, 0.20]
1.2 Postmenopausal women	2	106	Odds Ratio (M‐H, Fixed, 95% CI)	0.04 [0.01, 0.17]
2 Intraoperative complications Show forest plot	12	901	Odds Ratio (M‐H, Fixed, 95% CI)	0.37 [0.18, 0.77]

2.1 Premenopausal women	8	667	Odds Ratio (M‐H, Fixed, 95% CI)	0.27 [0.11, 0.65]
2.2 Postmenopausal women and women pretreated with GnRHa	5	234	Odds Ratio (M‐H, Fixed, 95% CI)	0.97 [0.21, 4.47]
3 Specific intraoperative complications Show forest plot	11		Odds Ratio (IV, Fixed, 95% CI)	Subtotals only

3.1 Cervical laceration/tear	9	669	Odds Ratio (IV, Fixed, 95% CI)	0.25 [0.11, 0.57]
3.2 False track	7	560	Odds Ratio (IV, Fixed, 95% CI)	0.34 [0.12, 0.97]
3.3 Uterine perforation	7	455	Odds Ratio (IV, Fixed, 95% CI)	0.42 [0.13, 1.38]
3.4 Uterine bleeding	4	340	Odds Ratio (IV, Fixed, 95% CI)	0.51 [0.10, 2.49]
4 Time required to dilate the cervix (sec.) Show forest plot	7		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5 Preoperative pain score Show forest plot	4	200	Mean Difference (IV, Fixed, 95% CI)	1.25 [0.77, 1.72]

6 Cervical width (dilator size in mm) Show forest plot	12		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

7 Failure to dilate the cervix Show forest plot	10	690	Odds Ratio (M‐H, Fixed, 95% CI)	0.09 [0.01, 0.82]

8 Side effects Show forest plot	4	272	Odds Ratio (M‐H, Fixed, 95% CI)	2.59 [1.15, 5.79]

9 Types of side effects Show forest plot	7		Odds Ratio (IV, Fixed, 95% CI)	Subtotals only

9.1 Mild abdominal pain	5	548	Odds Ratio (IV, Fixed, 95% CI)	8.48 [3.77, 19.04]
9.2 Vaginal bleeding	6	532	Odds Ratio (IV, Fixed, 95% CI)	7.09 [2.83, 17.78]
9.3 Nausea	5	489	Odds Ratio (IV, Fixed, 95% CI)	2.41 [0.66, 8.75]
9.4 Diarrhoea	5	489	Odds Ratio (IV, Fixed, 95% CI)	5.66 [0.96, 33.16]
9.5 Increased body temperature	2	243	Odds Ratio (IV, Fixed, 95% CI)	5.25 [1.28, 21.44]
9.6 Shivering	2	86	Odds Ratio (IV, Fixed, 95% CI)	0.91 [0.09, 9.18]
10 Duration of operation( min..) Show forest plot	3		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 1. Misoprostol versus placebo or no treatment

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Comparison 2. Misoprostol versus dinoprostone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Ease of dilatation: need for mechanical dilatation Show forest plot	1	310	Odds Ratio (M‐H, Fixed, 95% CI)	0.58 [0.34, 0.98]

2 Intraoperative complications Show forest plot	1	310	Odds Ratio (M‐H, Fixed, 95% CI)	0.32 [0.12, 0.83]

3 Types of side effects Show forest plot	1		Odds Ratio (IV, Fixed, 95% CI)	Totals not selected

3.1 Mild abdominal pain	1		Odds Ratio (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Vaginal bleeding	1		Odds Ratio (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 Headache	1		Odds Ratio (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.4 Nausea	1		Odds Ratio (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.5 Vomiting	1		Odds Ratio (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.6 Diarrhoea	1		Odds Ratio (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.7 Increased body temperature	1		Odds Ratio (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Time required to dilate the cervix (sec.) Show forest plot	1	310	Mean Difference (IV, Fixed, 95% CI)	‐4.60 [‐8.61, ‐0.59]

5 Cervical width (dilator size in mm) Show forest plot	1	310	Mean Difference (IV, Fixed, 95% CI)	0.40 [0.21, 0.59]

6 Duration of operative hysteroscopy (min.) Show forest plot	1	310	Mean Difference (IV, Fixed, 95% CI)	3.20 [1.16, 5.24]

Comparison 2. Misoprostol versus dinoprostone

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Comparison 3. Misoprostol versus osmotic dilator

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Ease of dilatation: need for mechanical dilatation Show forest plot	1	110	Odds Ratio (M‐H, Fixed, 95% CI)	5.96 [2.61, 13.59]

1.1 Misoprostol vs natural osmotic dilator	1	110	Odds Ratio (M‐H, Fixed, 95% CI)	5.96 [2.61, 13.59]
2 Intraoperative complications Show forest plot	3	354	Odds Ratio (M‐H, Fixed, 95% CI)	5.14 [0.24, 109.01]

2.1 Misoprostol vs natural osmotic dilator	2	254	Odds Ratio (M‐H, Fixed, 95% CI)	5.14 [0.24, 109.01]
2.2 Misoprostol vs synthetic osmotic dilator	1	100	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Time required to dilate the cervix (sec.) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.1 Misoprostol versus natural osmotic dilator	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Cervical width (dilator size in mm) Show forest plot	3		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.1 Misoprostol vs natural osmotic dilator	2		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.2 Misoprostol vs synthetic dilator	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 3. Misoprostol versus osmotic dilator

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