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

Primary Purpose

Preterm Birth, Obstetric Labor, Premature

Status

Unknown status

Phase

Phase 3

Locations

Panama

Study Type

Interventional

Intervention

17 α hydroxyprogesterone caproate

Placebo

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Progesterone, Obstetric labor, premature, Short cervix

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Saint Thomas Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

17 α hydroxyprogesterone caproate

Placebo

Arm Description

17α-Hydroxyprogesterone caproate.

Saline solution.

Outcomes

Primary Outcome Measures

Incidence of preterm birth (before 37 weeks of gestation)

Number of patients that delivered before 37 weeks of pregnancy

Secondary Outcome Measures

Incidence of preterm birth before 35 weeks of pregnancy

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

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.

Full Information

NCT ID

NCT01317225

First Posted

March 16, 2011

Last Updated

January 3, 2015

Sponsor

Saint Thomas Hospital, Panama

1. Study Identification

Unique Protocol Identification Number

NCT01317225

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2011 (undefined)

Primary Completion Date

July 2015 (Anticipated)

Study Completion Date

August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Saint Thomas Hospital, Panama

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Birth, Obstetric Labor, Premature

Keywords

Progesterone, Obstetric labor, premature, Short cervix

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

17 α hydroxyprogesterone caproate

Arm Type

Experimental

Arm Description

17α-Hydroxyprogesterone caproate.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Saline solution.

Intervention Type

Drug

Intervention Name(s)

17 α hydroxyprogesterone caproate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Saline solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of preterm birth (before 37 weeks of gestation)

Description

Number of patients that delivered before 37 weeks of pregnancy

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Incidence of preterm birth before 35 weeks of pregnancy

Description

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.

Time Frame

18 months

Title

Incidence of preterm birth before 32 weeks of pregnancy

Description

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.

Time Frame

18 months

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Osvaldo A Reyes, MD (Gyn/Ob)

Phone

011(507)65655041

oreyesmaternidad@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Rodrigo Velarde, MD (Gyn/Ob)

Phone

011(507)66159954

revelarde_14@yahoo.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osvaldo A Reyes, MD (Gyn/Ob)

Organizational Affiliation

Saint Thomas Maternity Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rodrigo Velarde, MD (Gyn/Ob)

Organizational Affiliation

Saint Thomas Maternity Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saint Thomas Maternity Hospital

City

Panama

Country

Panama

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Osvaldo A Reyes, MD (Gyn/Ob)

Phone

011(507)65655041

oreyesmaternidad@gmail.com

First Name & Middle Initial & Last Name & Degree

Rodrigo Velarde, MD (Gyn/Ob)

Phone

011(507)66159954

revelarde_14@yahoo.es

First Name & Middle Initial & Last Name & Degree

Osvaldo A Reyes, MD (Gyn/Ob)

First Name & Middle Initial & Last Name & Degree

Rodrigo Velarde, MD (Gyn/Ob)

12. IPD Sharing Statement

Learn more about this trial

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

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