Investigated device |
Arabin pessary |
Arabin pessary |
Arabin
pessary |
Arabin pessary |
Arabin pessary |
Arabin pessary |
Arabin
pessary |
Arabin pessary |
Bioteque cup pessaries |
Arabin
pessary |
Number of subjects with pessary placed (n) |
166 |
190 |
150 |
68 |
148 |
401 |
460 |
588 |
60 |
250 |
Singleton/Twin pregnancies |
Singletons and twins |
Singletons |
Singletons |
Twins |
Twins |
Twins |
Singletons |
Twins |
Singletons |
Twins |
Teaching/ Audit
Details
|
Yes
The treatment was performed by three clinicians who had received
extensive training before
|
Not specified
|
Yes
The physicians had received practical training in the placement of
the device. Pessary insertion training consisted of a didactic session
and a hands-on session.
|
Yes
The central team in turn instructed the other centers in the use
of the pessary
|
Yes
Well-trained staff involved in pessary treatment
|
No
No specific training was provided
|
Yes
The research-team members who inserted the pessaries had received
practical training in the placement of the device.
|
No
Many research team doctors were involved in the insertion of the
pessary and they did not receive supervised training in doing so
|
Yes
In addition to didactic and hands-on training, all staff was
required to demonstrate competence in pessary placement on a live model
|
Yes (only by video)
Inserting obstetricians watched a training video on pessary
insertion, were provided with written guidance on pessary management,
and (at their discretion) practised pessary insertion on a model prior
to first insertion.
|
Vaginal discharge |
42.2% |
100% |
86.7% |
100% |
70% |
26% |
10.5% |
42.1% |
73.3% |
Not specified |
Early removal due to discomfort/pain
|
0.6%
|
<1% (one patient who needed removal and replacement of the
pessary)
|
0
|
Not specified
|
Not specified
|
<28 weeks: 30%
28-32 weeks: 9%
32 - 36 weeks: 0
32-36 weeks: 4%
|
10.2% of participants requested early removal for:
-discomfort (5.4%)
- vaginal discharge (4.1%)
- vaginal bleeding (0.7%)
|
5%
|
1.7% expelled it during sexual intercourse
1.7% requested pessary removal due to apprehension regarding potential
discomfort with sexual intercourse
|
11.3%
|
Discomfort during treatment
|
13.9%
|
Mean pain score: 4 (scale 0–10) during pessary insertion
|
3.3%
|
Mean pain score: 4 (scale 0–10) during pessary insertion
|
Discomfort (17%)
Pain 4%
|
4%
|
11.4%
|
5.8%
|
1.7%
removal for discomfort during sexual intercourse
|
11.3%
|
Pain during removal (mean score on a 0-10 scale) |
6.7 |
7 |
Not specified |
7 |
Not specified |
Not specified |
Not specified |
Not
specified |
Not specified |
Uncomfortable in 41.3% |
Clinical results |
22% of singleton and 37% of twin
pregnancies delivered before 34 weeks. |
Among women with CL≤25 mm,
spontaneous delivery < 34 weeks of gestation and neonatal
composite adverse outcomes were significantly less frequent in the
pessary group than in the expectant management group |
Among women with
asymptomatic short CL ≤25 mm, use of a cervical pessary, compared with
no pessary resulted in a lower rate of spontaneous preterm birth at less
than 34 weeks of gestation |
Cervical pessary associated with
significant reduction of PTB < 34w in twin pregnancies with
short CL ≤25 mm |
In women with twin pregnancies and cervical length
<38 mm cervical pessary and 400 mg vaginal progesterone
resulted in similar rates of PTB at < 34 weeks. The pessary
reduced poor perinatal outcomes. In women with CL <28 mm,
pessary reduced PTB <34 weeks and improved composite poor
perinatal outcome. |
No significant difference in total group but a
6-fold reduction of composite poor perinatal outcome y in the pessary
group in patients with a CL< 38 mm between 16 and 20 weeks |
No significant differences in preterm birth <34 weeks between
singleton pregnancies with pessary placed for short CL<25 mm
and the expectant management group. |
No significant differences in
preterm birth <34 weeks between unselected twin pregnancies
with pessary and the expectant management group. |
Cervical pessary use
was not associated with prevention of PTB in women with a singleton
pregnancy, short CL and no prior sPTB |
Cervical pessary did not reduce
preterm birth <34 weeks nor composite adverse neonatal outcome
in twin pregnancies with CL ≤35 mm when compared to standard
care |