Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone

Saint Thomas Hospital (HST)

Status and phase: Unknown; Phase 3

Conditions: Obstetric Labor, Premature; Preterm Birth

Treatments: Drug: 17 α hydroxyprogesterone caproate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01317225

MHST2011-01

Details and patient eligibility

About

The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy.

Full description

Preterm birth is one of the main causes of neonatal mortality and morbidity around the world, with serious repercussions on the health system and the families of the preterm baby. Many drugs have been evaluated with the purpose of preventing preterm birth in the patient at risk. One of these drugs is 17 α hydroxyprogesterone caproate. The purpose of this study is to evaluate if the use of biweekly doses of 17 α hydroxyprogesterone caproate in patients hospitalized with the diagnosis of threatened preterm labor, defined as the presence of uterine contractions and a short cervix (below the 10th percentile for the gestational age), can reduce the incidence of preterm birth in this high risk group population.

Enrollment: 80 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women between 26 and 34 weeks of gestation.
• Cervical length (determined by transvaginal ultrasound) below the 10th percentile for the gestational age.

Exclusion criteria

• Multiple gestations.
• Maternal pathologies in which preterm termination of pregnancy is required.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

17 α hydroxyprogesterone caproate

Experimental group

Description:

17α-Hydroxyprogesterone caproate.

Treatment:

Drug: 17 α hydroxyprogesterone caproate

Placebo

Placebo Comparator group

Description:

Saline solution.

Treatment:

Drug: Placebo