To assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix compared to standard treatment (no cerclage) in the prevention of extreme preterm birth (PTB) < 28 weeks of GA.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be extreme PTB < 28 weeks.
Secondary outcome
Secondary outcomes include a composite for adverse neonatal outcome, PTB < 24,
32 and 34 weeks,GA at delivery, PPROM, days on ventilation support, in NICU,
maternal quality of life and maternal outcomes, and societal costs. Outcome
measures are in line with the core outcome sets for evaluation of interventions
to prevent PTB.
Background summary
Twin pregnancies have a high risk on extreme preterm birth (PTB) at less than
28 weeks of gestation which is associated with increased risk of neonatal
morbidity and mortality. In the Netherlands, 250 women with a twin pregnancy
deliver at < 28 weeks per year, resulting in 157 perinatal deaths and 343
surviving neonates of whom a large proportion, after a long hospital stay,
suffer from the long term neurodevelopmental problems after extreme preterm
birth. PTB is multifactorial in its origin and it is unlikely that one strategy
will reduce all PTB. An asymptomatic short cervix (<= 25 mm) or detection of
asymptomatic dilatation at midpregnancy in twin pregnancies is associated with
high rates of extreme PTB and proven to be the best predictor for extreme PTB.
Treatment strategies such as vaginal or intramuscular progesterone or pessary
universally applied for all twin pregnancies have so far failed to be effective
in reducing PTB rates. A possible effective surgical method to reduce extreme
PTB in twin pregnancies with a short cervix or asymptomatic dilatation at
midpregnancy is a minor operative procedure, the placement of a vaginal
cerclage.
Hypothesis : A vaginal cerclage in women with a twin pregnancy and a
midpregnancy short cervix will reduce extreme PTB and perinatal mortality
compared to standard treatment
Study objective
To assess the effectiveness of a cerclage in women with a twin pregnancy with a
midpregnancy short cervix compared to standard treatment (no
cerclage) in the prevention of extreme preterm birth (PTB) < 28 weeks of GA.
Study design
International multicenter randomized controlled trial, with economic analyses
alongside it.
Intervention
Vaginal cerclage
Study burden and risks
Burden:All participating women will be enrolled after a transvaginal
cervical length measurement. Women will be counseld at the participating
hospital. The participating hospital can decide to measure the cervical length
again and if indicated perform physical examination to detect possible cervical
dilatation. Eligible women will be randomly allocated to receive either a
cervical cerclage or not. A cervical cerclage will be placed before 24weeks of
gestation, and will stay in situ up to 36 weeks gestation or until
delivery, whatever comes first. The procedure involves occlusion of the
cervix by means of a cervical suture or stitch, which is performed in the
operation theatre under general or spinal anesthesia and this is an invasive
procedure.
Risk: A vaginal cerclage is a minor and safe surgical procedure commonly
performed in singleton pregnancies with a short cervix or dilatation and a
previous preterm birth in all the participating centers, thus there is
experience in the participating hospitals. Potential complications of a
cerclage are infection, premature rupture of membranes , cervical laceration or
bleeding and anesthesia-related complications, occurring in approximately
0.3-2.5 %.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Women above the age of 16 years with a twin pregnancy and an asymptomatic short
cervix or dilatation at routine ultrasound investigation below 24 weeks of
pregnancy
Exclusion criteria
- Women with a mono-amniotic twin pregnancy
- Women with twin pregnancy in which one or both children are diagnosed with a
major structural, congenital or chromosomal abnormality that is likely to
influence the composite adverse neonatal outcome.
- Women with dilatation of the cervix and signs of clinical intra-uterine
infection, defined by the presence of fever >= 38 degrees Celsius.
- Women with overt symptoms of preterm labour at time of measurement of short
cervix (regular contractions, PPROM, recurrent blood loss).
- Women with a placenta previa, defined as a placenta position covering the
internal ostium of the cervix.
- Women who do not master the Dutch of English language and therefore not able
to give written consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82609.018.22 |