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

Preterm Birth Clinical Trial

Official title:

Use of 17α Hydroxyprogesterone Caproate for the Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor During Current Pregnancy. Double Blind, Randomized, Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01317225
• Other study ID #: MHST2011-01
• Status: Recruiting
• Phase: Phase 3
• First received: March 16, 2011
• Last updated: January 3, 2015
• Start date: June 2011
• Est. completion date: August 2015

Study information

• Verified date: January 2015
• Source: Saint Thomas Hospital, Panama
• Contact: Osvaldo A Reyes, MD (Gyn/Ob)
• Phone: 011(507)65655041
• Email: oreyesmaternidad[@]gmail.com
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth

Intervention

Drug:
• 17 a hydroxyprogesterone caproate
250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.
• Placebo
250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.

Locations

Country	Name	City	State
Panama	Saint Thomas Maternity Hospital	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of preterm birth (before 37 weeks of gestation)	Number of patients that delivered before 37 weeks of pregnancy	18 months	No
Secondary	Incidence of preterm birth before 35 weeks of pregnancy	To determine if the use of 17 a hydroxyprogesterone caproate can reduce the incidence of preterm birth before 35 weeks of gestation in patients with a previous episode of threatened preterm labor.	18 months	No
Secondary	Incidence of preterm birth before 32 weeks of pregnancy	To determine if the use of 17 a hydroxyprogesterone caproate can reduce the incidence of preterm birth before 32 weeks of gestation in patients with a previous episode of threatened preterm labor.	18 months	No