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Pessary or Progesterone to Prevent Preterm delivery in women with a twin pregnancy and short cervical length

Evaluating the effectiveness of a cervical pessary to improve neonatal outcome by preventing preterm birth in women with a twin pregnancy and a short cervix.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000875404
Acronym
Quad P-twins
Enrollment
34
Registered
2016-07-05
Start date
2020-01-31
Completion date
2023-06-29
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

Preterm birth, defined as birth before 37 weeks gestation, affects 22,000 pregnancies (7.5%) in Australia each year. While advances in neonatal care and treatments for preterm babies have greatly increased the chances of survival for even the smallest babies, preterm birth is still the leading cause of newborn death. Babies born before 37 weeks are also at risk for serious health problems including breathing difficulties, feeding problems, jaundice and effects on brain functions. Multiple pregnancy is a major risk factor for preterm birth, with 57% of twins born preterm compared to only 7% of singletons. Furthermore, 12% of twins are born before 32 weeks compared with only 2% of singletons. A short cervix, as measured by transvaginal ultrasound during the second trimester, is a powerful predictor of preterm birth. The risk of preterm delivery increases as the cervix shortens. When cervical length is less than 22 mm, women face a 20% probability of preterm delivery, which increases to 50% when the cervical length is less than 15 mm. Two currently available treatments used to reduce the incidence of preterm delivery in high risk women include the cerclage pessary and progesterone. Both of these interventions have been shown to effectively reduce the incidence of preterm birth in women with a short cervix. However, up until now, no study has directly compared the effectiveness of these two treatment options in women with twins. The purpose of this study is to directly compare the effectiveness of progesterone and cerclage pessaries in preventing preterm birth in women with a short cervix and twin pregnancy. Currently there is no standard treatment for short cervix in twin pregnancies. The standard treatment in singleton pregnancies is to offer progesterone. While the cerclage pessary is not widely used in Australia, it is widely used in Europe. A number of sites in Australia do use the cerclage pessary where they think it will be helpful. This study is similar to a larger one currently being conducted in the Netherlands. We will be watching that study closely to see if any of it’s outcomes inform us regarding the conduct of this study here in South Australia.

Interventions

Cerclage pessary. This is a dome shaped silicone device which is inserted into the vagina by an obstetrician. The cerclage pessary will remain in place from the time of insertion (approx 20 weeks gestation) until approximately 36 weeks gestation, or the onset of labour, whichever occurs first.

Sponsors

Women's and Children's Health Network
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Viable twin pregnancy Cervical length less than 38mm via transvaginal ultrasound assessment

Exclusion criteria

Placenta praevia Cervical cerclage in this pregnancy Identified major congenital anomaly Demise of one or both twins previous preterm birth (including of singleton) Previous participation in the Quad P-twin study

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 27, 2026