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

Sponsor

Saint Thomas Hospital, Panama (Other)

Overall Status

Unknown status

CT.gov ID

NCT01317225

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth Obstetric Labor, Premature	Drug: 17 α hydroxyprogesterone caproate Drug: Placebo	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

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.

Study Start Date :

Jun 1, 2011

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 17 α hydroxyprogesterone caproate 17α-Hydroxyprogesterone caproate.	Drug: 17 α hydroxyprogesterone caproate 250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.
Placebo Comparator: Placebo Saline solution.	Drug: Placebo 250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery. Other Names: Saline solution

Arm

Intervention/Treatment

Experimental: 17 α hydroxyprogesterone caproate

17α-Hydroxyprogesterone caproate.

Drug: 17 α hydroxyprogesterone caproate

250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.

Placebo Comparator: Placebo

Saline solution.

Drug: Placebo

250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.

Other Names:

Saline solution

Outcome Measures

Primary Outcome Measures

Incidence of preterm birth (before 37 weeks of gestation) [18 months]
Number of patients that delivered before 37 weeks of pregnancy

Secondary Outcome Measures

Incidence of preterm birth before 35 weeks of pregnancy [18 months]
To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 35 weeks of gestation in patients with a previous episode of threatened preterm labor.
Incidence of preterm birth before 32 weeks of pregnancy [18 months]
To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 32 weeks of gestation in patients with a previous episode of threatened preterm labor.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Thomas Maternity Hospital	Panama		Panama

Sponsors and Collaborators

Saint Thomas Hospital, Panama

Investigators

Principal Investigator: Osvaldo A Reyes, MD (Gyn/Ob), Saint Thomas Maternity Hospital
Principal Investigator: Rodrigo Velarde, MD (Gyn/Ob), Saint Thomas Maternity Hospital