1. Pessaria in de verloskunde: preventie van preterme partus
VVOG Lentevergadering 2013
Liesbeth Lewi, UZ Leuven

2. Preventie preterme partus bij eenling zwangerschap: PECEP trial
11149 did not meet inclusion criteria:
10568 cervix > 25 mm
351 fetal abnormalities
126 contractions
104 bleeding
726 cervix ≤ 25 mm
eligible women
consented
6360 declined to participate
385 randomly assigned
341 declined to participate
3 lost to follow up
190 included in
intention-to-treat analysis
2 lost to follow up
192 assigned to
Arabin pessary
193 assigned to
expectant management
april
Primary endpoint: spontane preterme partus voor 34 weken
Goya et al .Lancet ;379(9828):1800-6

3. Arabin cervical pessary group Expectant management group (n=190)
PECEP trial: Results
Arabin cervical pessary group
(n=190)
Expectant management group (n=190)
Odds ratio
(95% CI)
P value
Pregnancy outcome
Spontaneous delivery before 28 weeks
4 (2%)
16 (8%)
0.23 ( )
0.0058
Spontaneous delivery before 34 weeks
12 (6%)
51 (27%)
0.18 ( )
<0.0001
Any delivery before 34 weeks
14 (7%)
53 (28%)
0.21 ( )
Spontaneous delivery before 37 weeks
41 (22%)
113 (59%)
0.19 ( )
Gestational age at delivery (weeks)
37.7 (2.0)
34.9 (4.0)
Goya et al .Lancet ;379(9828):1800-6

4. PECEP trial: Results Goya et al .Lancet. 2012 12;379(9828):1800-6
Kaplan-Meier plot of the probability of continued pregnancy without delivery in the cervical pessary and expectant management groups
Goya et al .Lancet ;379(9828):1800-6

5. Arabin cervical pessary group Expectant management group (n=190)
PECEP trial: Results
Arabin cervical pessary group
(n=190)
Expectant management group (n=190)
Odds ratio
(95% CI)
P value
Perinatal outcome
Fetal death -
Neonatal death
1 (<1%)
Birthweight less than 1500 g
9 (5%)
26 (14%)
0.31 ( )
0.0040
Birthweight less than 2500 g
17 (9%)
56 (29%)
0.23 ( )
<0.0001
Adverse outcomes
Necrotising enterocolitis
2 (1%)
0.4987
Intraventricular haemorrhage
Respiratory distress syndrome
5 (3%)
23 (12%)
0.20 ( )
0.0003
Retinopathy
Treatment for sepsis
3 (2%)
12 (6%)
0.24 ( )
0.0317
Composite adverse outcomes
30 (16%)
0.14 ( )
<0.001
Goya et al .Lancet ;379(9828):1800-6

6. PECEP trial: nevenwerkingen
Arabin cervical pessary group
(n=190)
Expectant management group (n=190)
Odds ratio
(95% CI)
P value
Side-effects
Vaginal discharge
190 (100%)
87 (46%) ..
0.002
Pessary repositioning without removal
27 (14%)
Pessary withdrawal
1 (<1%)
Goya et al .Lancet ;379(9828):1800-6

7. PECEP trial: nevenwerkingen
Goya et al .Lancet ;379(9828):1800-6

8. PECEP trial: Insertie en verwijdering van pessarium
Arabin cervical
Pessary group
(n=190)
Expectant
Management group
(n= 190)
Pain during insertion
(from 0 to 10) 4
Pain during removal 7
Recommend to others
181 (95%)
Sexual intercourse
58 (31%)
64 (34%)
Goya et al .Lancet ;379(9828):1800-6
Goya et al .Lancet May 12;379(9828):1800-6

9. Problemen met PCEP trial
Te hoge incidentie van PTB < 34 w in de controle groep
Bij cervixlengte van < 25 mm verwacht men een 5-10% PTB < 34 w ipv 27%
N=110
Goya et al .Lancet ;:1800-6; Hui et al Am J Perinatol [Epub ahead of print]; FMF pessary trial [oral communication]
FMF pessary trial (n=800): no difference 10% vs 10% PTB <34 w

10. Preventie preterme partus bij tweelingzwangerschap: ProTwin trial
Liem et al Oral Communication 2013 SMFM San Francisco

11. ProTwin trial
Liem et al Oral Communication 2013 SMFM San Francisco

12. ProTwin trial: Results
Liem et al Oral Communication 2013 SMFM San Francisco

13. ProTwin trial: Results
Liem et al Oral Communication 2013 SMFM San Francisco

14. ProTwin trial: Results
Liem et al Oral Communication 2013 SMFM San Francisco

15. ProTwin trial: Results
Ook reductie in NN morbiditeit 25% versus 10%
Liem et al Oral Communication 2013 SMFM San Francisco

16. Voor eenling zwangerschappen
Take Home Message…..
Voor eenling zwangerschappen
TV cervixlengtemeting->vaginaal progesterone zo <20 mm
Voor tweeling zwangerschappen
? TV cervixlengtemeting->vaginaal progesterone zo <25 mm
? TV cervixlengtemeting->pessarium zo <38 mm
45% reductie van partus > 33 weken, 61% reductie in RR distress syndrome
Romero R, BJOG 2012