Apostel VI - Will a cervical pessary prolong pregnancy in women after an episode of threatened preterm labor.

Apostel VI - Will a cervical pessary prolong pregnancy in women after an episode of threatened preterm labor: a randomized trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28719

Enrollment

200

Registered

2013-10-16

Start date

2013-10-16

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Pregnancy, Preterm birth, Threatened preterm labor, Pessary

Interventions

Eligible women will be randomly allocated to receive either a cervical pessary or no intervention. The cervical pessary will be placed in situ when undelivered, 48 hours after an episode of threatene

Eligibility

Inclusion criteria

Inclusion criteria: -singleton/twin pregnancy -GA between 24+0 and 34+6 weeks - Cervical length >15mm-<30mm and positive fibronectin - undelivered after 48 hours

Exclusion criteria

Exclusion criteria: -major fetal abnormalities -signs of intra-uterine infection -ruptured membranes -cervical dilatation > 3cm -Residual cervical length that makes it impossible to place a pessary -randomisation >72 hours after becoming eligible

Design outcomes

Primary

Measure	Time frame
Preterm delivery <37 weeks of gestation.	—

Secondary

Measure	Time frame
Neonatal outcomes; composite of neonatal morbidity (e.g. RDS, BPD, IVH, NEC, PVL, sepsis) and death. Delivery outcomes: e.g. GA at delivery, time to delivery and preterm birth rates <34 and <32 weeks. Maternal outcomes: side-effects, complications of pessary	—

Contacts

Public ContactF.J.R. Hermans

Academic Medical Center Amsterdam, Meibergdreef 9

apostel6@studies-obsgyn.nl+31 (0) 20 566 4256

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)