Will a cervical pessary prolong pregnancy in women who have been discharged after an episode of threatened preterm labor: a multicenter randomised clinical trial

Will a cervical pessary prolong pregnancy in women who have been discharged after an episode of threatened preterm labor: a multicenter randomised clinical trial - APOSTEL VI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45116

Enrollment

200

Registered

2013-09-12

Start date

2013-11-04

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preterm birth preterm labour

Interventions

Women will be randomized for either a cervical pessary or for no intervention.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Singleton or twin pregnancy Gestational age between 24 0/7 and 34 6/7 weeks Undelivered 48 hours after admission for preterm labor At admission a Cervical length

Exclusion criteria

Exclusion criteria: Major fetal abnormalities Ruptured membranes Signs of intra-uterine infection Signs of fetal distress Cervical dilatation * 3 cm Residual cervical length that makes it impossible to place a pessary >72 hours past after becoming eligible

Design outcomes

Primary

Measure	Time frame
Primary outcome is preterm delivery before 37 weeks	—

Secondary

Measure	Time frame
Secondary outcomes will be neonatal morbidity and mortality, time to delivery, gestational age at delivery and re-admittance for new symptoms of preterm labour.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)