RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix (SCAN)

The George Washington University Biostatistics Center

Status and phase: Terminated; Phase 3

Conditions: Preterm Delivery; Cervical Length

Treatments: Drug: 17 alpha-hydroxyprogesterone caproate; Other: Placebo Oil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00439374

U10HD053097 (U.S. NIH Grant/Contract)

U10HD034116 (U.S. NIH Grant/Contract)

U10HD040544 (U.S. NIH Grant/Contract)

U10HD053118 (U.S. NIH Grant/Contract)

U10HD040545 (U.S. NIH Grant/Contract)

U10HD036801 (U.S. NIH Grant/Contract)

U10HD034136 (U.S. NIH Grant/Contract)

U10HD040500 (U.S. NIH Grant/Contract)

U10HD027915 (U.S. NIH Grant/Contract)

U10HD027917 (U.S. NIH Grant/Contract)

U10HD027869 (U.S. NIH Grant/Contract)

U10HD034208 (U.S. NIH Grant/Contract)

U10HD040560 (U.S. NIH Grant/Contract)

U10HD040512 (U.S. NIH Grant/Contract)

U10HD040485 (U.S. NIH Grant/Contract)

U10HD021410 (U.S. NIH Grant/Contract)

HD36801 SCAN

Details and patient eligibility

About

The purpose of this study is to see if giving progesterone medication to pregnant women, who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers the risk of early delivery and improves the health of their baby.

Full description

Preterm births, defined as the delivery of a baby less than 37 weeks of gestation, are responsible for the majority of neonatal mortality and morbidities. Studies have shown that a number of risk factors, including never having a baby before and having a short cervix are associated with early delivery. Recently the NICHD did a study in women who were pregnant again after having delivered preterm. It showed that giving 17 alpha-hydroxyprogesterone caproate (17P) medication during pregnancy decreased the chance of delivering another preterm baby by 34%. This placebo-controlled randomized clinical trial will address the primary research question: does treatment with 17P initiated before 23 weeks of gestation prevent delivery prior to 37 weeks in nulliparous women with a singleton gestation who have a short cervix?

Enrollment: 657 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Nulliparous
• Cervical length as measured on transvaginal examination < 30mm between gestational ages of 16 weeks 0 days to 22 weeks 3 days
• Gestational age 16 weeks 3 days to 22 weeks 6 days at time of randomization

Exclusion criteria

• Multifetal gestation
• Progesterone treatment after 14 weeks 6 days during current pregnancy
• Vaginal bleeding, heavier than spotting, after 15 weeks 6 days
• Amniotic membranes prolapsed beyond external os
• Preterm rupture of membranes
• Fetal anomaly
• Pregnancy without a viable fetus
• Current or planned cervical cerclage
• Congenital Mullerian abnormality of the uterus
• Contraindication to intra-muscular injections
• Hypertension requiring medication
• Diabetes managed with insulin or oral hypoglycemic agents
• DES exposure
• Cervical surgery such as cold knife conization
• Planned indicated preterm delivery
• Participation in another interventional study that influences age at delivery
• Participation in this trial in a previous pregnancy
• Prenatal care or delivery planned outside a MFMU Network center

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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657 participants in 2 patient groups, including a placebo group

17 alpha-hydroxyprogesterone caproate

Active Comparator group

Description:

250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery

Treatment:

Drug: 17 alpha-hydroxyprogesterone caproate

Placebo

Placebo Comparator group

Description:

Placebo oil given by weekly injection until 37 weeks gestation or delivery.

Treatment:

Other: Placebo Oil