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Double blind randomised placebo controlled trial of progesterone for the prevention of preterm birth in twins

Double blind randomised placebo controlled trial of progesterone for the prevention of preterm birth in twins

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35782581
Enrollment
500
Registered
2005-07-25
Start date
2005-11-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Preterm delivery Pregnancy and Childbirth Preterm delivery

Interventions

Vaginal progesterone, 90 mg daily for ten weeks from 24 weeks gestation versus placebo

Sponsors

Greater Glasgow Health Board (North Glasgow University Hospitals Division) and the University of Glasgow (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women with twin pregnancy 2. Gestation established by scan before 20 weeks gestation 3. Known chorionicity

Exclusion criteria

Exclusion criteria: 1. Known signficiant structural or chromosomal fetal abnormality 2. Contraindications to progesterone 3. Planned cervical suture 4. Planned elective delivery before 34 weeks gestation 5. Intervention for twin to twin transfusion before 22 weeks

Design outcomes

Primary

MeasureTime frame
Proportion of women in each group delivering before 34 weeks gestation

Secondary

MeasureTime frame
Pregnancy duration, maternal complication rates, neonatal complication rates, maternal side effects, acceptability of treatment, subject perception of alternatives, perinatal mortality, perinatal morbidity

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026