Table 30Strength of the evidence for harms of interventions for management of PPH

Intervention

Outcome
Study Design

Quality and Number of Studies (N Total With PPH)
Study LimitationsaConsistencyDirectnessPrecisionReporting BiasFinding
Strength of Evidence Grade
Pharmacologic
Tranexamic acid

All harms
RCT-1 good (114)69LowUnknownDirectImpreciseUndetectedInsufficient SOE due to small sample size, but serious harms did not differ between groups and mild, transient harms occurred more often in TXA group
Sulprostone

All harms
Case series-1 poor (1370)70HighUnknownDirectPreciseNAInsufficient SOE as only one study considered poor quality for harms reporting
Methylergonovine maleate

Acute coronary syndrome and myocardial infarction
Retrospective cohort study-1 good (139,617)60LowUnknownDirectPreciseNALow SOE for lack of association of methylergonovine maleate with acute coronary syndrome and myocardial infarction; no significant difference in the incidence of these conditions in the exposed and non-exposed groups
Carboprost tromethamine

All harms
Case series-1 poor (237) 71HighUnknownDirectImpreciseNAInsufficient SOE as only one study considered poor quality for harms reporting
rFVIIa

Thromboembolic events
Case-control-1 fair (12)74

Retrospective cohort-1 fair (48)73

Retrospective case series- 1 good, 2 poor (unclear due to overlap of 2 studies)75, 76, 80
HighConsistentDirectImpreciseNAInsufficient SOE; 4 of 5 studies (unclear overlap in 2 studies) reported thromboembolic events (pulmonary embolus, deep vein thrombosis, myocardial infarction) but sample sizes were small and study limitations are high
Other Medical Interventions
Transfusion for supportive management of PPH

All harms
Retrospective cohort-2 poor (1574)83, 84

Pre-post-1 poor (93)86

Case series-1 good, 3poor (1152)61, 63, 65, 81
HighInconsistentDirectPreciseNAInsufficient SOE due to inconsistency, study limitations
Procedures
Uterine balloon tamponade

All harms
Pre-post-1 poor (43)87

Case series-2 poor (102)80, 90
HighConsistentDirectImpreciseNAInsufficient SOE due to small studies with high limitations
Embolization
InfertilityRetrospective cohort-2 poor (152)92-95

Case-control-1 poor (53)91

Case series-2 poor (169) 97, 98
HighInconsistentDirectImpreciseNALow SOE for negative effect of embolization on future fertility. Infertility rate among women who had embolization in these studies was greater than that of the overall population rate (range 0-43%), but few women (n = 300) available for long-term followup; high study limitations and inconsistency among studies
Spontaneous abortion in subsequent pregnancyRetrospective cohort-2 poor (152)92-95

Case-control-1 poor (53)91

Case series-1 good, 3 poor (421) 97, 98, 105, 108
HighConsistentDirectImpreciseNALow SOE for lack of association between embolization and spontaneous abortion in subsequent pregnancy in the small number of women followed-up; rates ranged from 5-21.4%, which is comparable to estimates in the general population
Menstrual changesRetrospective cohort-2 poor (152)92-95

Case-control-1 poor (53)91

Case series-1 good, 4 poor (709) 97, 98, 101, 105, 108
HighConsistentDirectImpreciseNALow SOE for an association between embolization and menstrual changes. Rates of menstrual change (heavier, lighter, or irregular menses and amenorrhea) ranged from 2 to 22%
HematomaRetrospective cohort-2 poor (152)92-95

Case-control-1 poor (53)91

Case series-1 good, 2 poor (544)101, 105, 106
HighConsistentDirectPreciseNALow SOE for association between embolization and hematoma; rates ranged from 1.7-6%
Surgical Interventions
Uterine compression sutures
Preterm birthCase-control-2 good (105 with PPH and sutures)62, 66MediumConsistentDirectImpreciseNALow SOE for no effect of sutures on preterm birth; in 2 studies; preterm births did not differ between women in case and control groups
Ligation

Surgical injury
Retrospective cohort study-1 poor (48)96

Case series-1 poor (539-not clear how many had ligation)111
HighConsistentDirectImpreciseNAInsufficient due to high study limitations and imprecision; injuries (inadvertent ligation of the ureters and secondary hysterectomy disunion with sepsis) related to ligation reported in both studies
Hysterectomy
Bladder and ureter lesionsProspective cohort-1 poor (108)109

Case series-5 poor (2784)45, 64, 110, 115, 116
HighConsistentDirectPreciseNALow SOE for association of hysterectomy and operative organ damage; rates of bladder and ureter lesions ranged from 6%-12% and 0.4%-41%, respectively
ReoperationProspective cohort-1 poor (108)109

Case series-3 poor, 1 good (574)110, 115-117
HighConsistentDirectPreciseNALow SOE for association between hysterectomy and reoperation. Rates of reoperation ranged from 1.8-29%
a

Note: Study limitations are rated on a low to high scale. Low limitations=more rigorously designed study.

Abbreviations: LOS = length of stay; NA = not applicable; PPH = postpartum hemorrhage; RCT = randomized controlled trial; SOE = strength of the evidence; TXA = tranexamic acid

From: Discussion

Cover of Management of Postpartum Hemorrhage
Management of Postpartum Hemorrhage [Internet].
Comparative Effectiveness Reviews, No. 151.
Likis FE, Sathe NA, Morgans AK, et al.

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