The effectiveness of Cerclage for the reduction of extreme preterm birth and perinatal mortality in Twin pregnancies with a short cervix.

Recruiting

Conditions: 10010273
Premature birth
Preterm birth
preterm deliveru

Registration Number: NL-OMON53843

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be extreme PTB < 28 weeks.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include a composite for adverse neonatal outcome, PTB < 24,<br /><br>32 and 34 weeks,GA at delivery, PPROM, days on ventilation support, in NICU,<br /><br>maternal quality of life and maternal outcomes, and societal costs. Outcome<br /><br>measures are in line with the core outcome sets for evaluation of interventions<br /><br>to prevent PTB.</p><br>