Does progesterone prophylaxis to prevent preterm labour improve outcome? - a randomised double blind placebo controlled trial (OPPTIMUM) - OPPTIMUM

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007950-77-GB

Enrollment

1250

Registered

2008-02-08

Start date

2008-07-02

Completion date

Unknown

Last updated

2020-10-13

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

Conditions

Preterm labour

Interventions

Trade Name: Utrogestan Pharmaceutical Form: Capsule, soft Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Vaginal use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: High risk for PTB as indicated by: at least one of (i) history of previous PTB/ second trimester loss (ii) previous preterm premature rupture of the fetal membranes (iii) short cervical length (< 25mm) on ultrasound at 18 – 22 weeks gestation. Additionally all will have a positive fFN at 22weeks. All women will have gestation established by scan at =16 weeks. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: Known significant structural or chromosomal fetal anomaly; known sensitivity, contraindication or intolerance to progesterone; suspected or proven rupture of the fetal membranes at the time of recruitment; multiple pregnancy; prescription or ingestion of medications known to interact with progesterone (eg ketoconazole and ciclosporin).

Design outcomes

Primary

Measure	Time frame
Main Objective: In women at high risk of preterm labour, does prophylactic vaginal natural progesterone, 200mg daily from 22 – 34 weeks gestation, compared to placebo: i.Improve obstetric outcome by lengthening pregnancy and thus reducing the incidence of preterm delivery (before 34 weeks gestation)? ii.Improve neonatal outcome by reducing a composite of death and major morbidity? iii.Lead to improved childhood cognitive and neurosensory outcomes at two years? iv.Represent cost effective management for women at high risk of preterm delivery? ;Secondary Objective: None;Primary end point(s): •Obstetric:Delivery before 34+0 completed weeks of gestation based on ultrasound. •Neonatal: Composite outcome of death, brain injury or severe chronic lung disease [61]. •Early childhood: The Bayley III cognitive scale standardised score [62] at two years of chronological age	—

Measure

Time frame

Main Objective: In women at high risk of preterm labour, does prophylactic vaginal natural progesterone, 200mg daily from 22 – 34 weeks gestation, compared to placebo: i.Improve obstetric outcome by lengthening pregnancy and thus reducing the incidence of preterm delivery (before 34 weeks gestation)? ii.Improve neonatal outcome by reducing a composite of death and major morbidity? iii.Lead to improved childhood cognitive and neurosensory outcomes at two years? iv.Represent cost effective management for women at high risk of preterm delivery? ;Secondary Objective: None;Primary end point(s): •Obstetric:Delivery before 34+0 completed weeks of gestation based on ultrasound. •Neonatal: Composite outcome of death, brain injury or severe chronic lung disease [61]. •Early childhood: The Bayley III cognitive scale standardised score [62] at two years of chronological age

—

Countries

Sweden, United Kingdom

Contacts

Public ContactProfessor Jane Norman

University of Edinburgh

jane.norman@ed.ac.uk441312422696

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026