A Comparison of Medical Management with Misoprostol and Surgical Management for Early Pregnancy Failure Flashcards Preview

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Flashcards in A Comparison of Medical Management with Misoprostol and Surgical Management for Early Pregnancy Failure Deck (11)
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1

Journal
Year

Journal: The New England Journal of Medicine 2005

2

Aims

To assess efficacy, safety, and acceptability of misoprostol

3

Study Design

RCT

4

Participants

652 women with 1st-trimester pregnancy failure

5

Inclusion Criteria

- Women who had anembryonic gestation or embryonic/fetal death with US
o Embryonic pole or CRL 5-40mm without cardiac activity
o Anembryonic gestational sac with MSD 16-45mm
o Growth of gestational sac <2mm over 5/7, or <3mm over 7/7
o Increase in hCG of <15% over 2/7 with yolk sac visualized
o Incomplete or inevitable abortion
 Incomplete = passage of some POC with residual anteroposterior lining >30mm on TVUS and uterine size indicating <13/40
 Inevitable = IU gest sac <45mm or embryonic pole <40mm and internal cervical os open to digital examination with active PV bleeding

6

Exclusion Criteria

- Anaemia = Hb <9.5
- Haemodynamic instability
- History of clotting disorder or using anticoagulants (not including aspirin)
- Allergic to PGs or NSAIDs
- Or previously undergone surgical or medical abortion that was either self-induced or induced by other physicians during current pregnancy

7

Intervention

- Randomly assigned to receive 800mcg misoprostol PV or to undergo vacuum aspiration in 3:1 ratio
- Misoprostol: treatment on D1, 2nd dose on D3 if expulsion incomplete, vacuum aspiration on D8 if expulsion still incomplete
- Treatment failure = surgical treatment (for misorprostol group) or repeated aspiration (for vaccum-aspiration group) within 30 days after initial treatment

8

Primary end-points

Treatment failure = surgical Tx (misoprostol group) or repeated aspiration (surgery group) within 30/7 of initial Tx

9

Summary of results

- Misoprostol (491 women)
o 71% complete expulsion by D3, 84% complete expulsion by D8
o 78% would use again, 83% would recommend to others
- Treatment failure: misoprostol 16%, surgical 3%
- Haemorrhage or endometritis requiring hospitalization was rare (<1% in each group, no significant difference)

10

Limitations

- Women who had anembryonic gestation or embryonic or fetal death overrepresented
- Only studied vaginal administration of misoprostol (Prev studies indicated efficacy is similar in PV or PO, but SEs higher in PO
- Unknown whether 800mcg misoprostol represents lowest effective dose

11

Conclusion

- Treatment of early pregnancy failure with 800mcg of misoprostol vaginally is a safe and acceptable approach, with a success rate of ~84%