Clinical trial NCT00422526: Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial
Official title: Randomised Study to Examine the Effectiveness of Progesterone in Preventing Severe Preterm Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preterm Birth
Pregnancy Trimester, Second
Keywords: Preterm delivery, short cervix, progesterone
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2007-01-17
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with a short cervical length of 15mm.

Detailed description: BACKGROUND The results of randomized studies have shown that the prophylactic use of progesterone in women who previously delivered prematurely reduces the risk of recurrence. Asymptomatic women found to have a short cervix (\< 15 mm) at mid-gestation are at greatly increased risk for spontaneous early preterm delivery and it is uncertain whether in such women the risk is reduced by progesterone.

METHODS Cervical length was measured by transvaginal sonography at 22 (range 20-25) weeks in 24,620 pregnant women attending for routine antenatal care. The cervix was 15 mm or less in 413 (1.7%), and 250 (60.5%) of these women participated in a randomized study of vaginal progesterone (200 mg per night) vs identical-looking placebo, between 24 and 34 weeks. Primary outcome was the frequency of spontaneous delivery before 34 weeks (238 days) of pregnancy. Analysis was performed according to the intention-to-treat principle.

Eligibility criteria: Inclusion Criteria:

* All women with singleton or twin pregnancies attending for routine ultrasound examination at 20-25 weeks of gestation with a short cervical length (\<15 mm).

Exclusion Criteria:

* Women with major fetal abnormalities,
* Painful regular uterine contractions, or history of ruptured membranes or cervical cerclage in-situ were excluded from screening.

Primary outcomes:
measure: Spontaneous delivery before 34 completed weeks (238 days) of gestation.
Secondary outcomes:
measure: Birth weight, fetal or neonatal death, major adverse outcome before discharge from hospital and need for neonatal special care (admission to special care baby unit, phototherapy, treatment of proven or suspected sepsis, or blood transfusion).
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital do Servidor Publico Estadual-FMO
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile
city: Larissa
country: Greece
facility: University Hospital
city: Kent
country: United Kingdom
facility: Darent Valley Hospital
city: London
country: United Kingdom
facility: University Hospital of Lewisham
city: London
country: United Kingdom
facility: Queen Elizabeth Hospital, NHS Trust Woolwich
city: London
country: United Kingdom
facility: King's College Hospital NHS Foumdation Trust
city: London
country: United Kingdom
facility: Southend University Hospital, Essex
Study officials:
affiliation: King's College London
name: Kypros H Nicolaides, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9. doi: 10.1056/NEJMoa067815.