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

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ClinicalTrials.gov Identifier: NCT01317225
Recruitment Status : Unknown
Verified January 2015 by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama.
Recruitment status was:  Recruiting
First Posted : March 17, 2011
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2011
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : August 2015

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Arms and Interventions
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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 Name: Saline solution


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of preterm birth (before 37 weeks of gestation) [ Time Frame: 18 months ]
    Number of patients that delivered before 37 weeks of pregnancy


Secondary Outcome Measures :
  1. Incidence of preterm birth before 35 weeks of pregnancy [ Time Frame: 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.

  2. Incidence of preterm birth before 32 weeks of pregnancy [ Time Frame: 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
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317225


Contacts
Contact: Osvaldo A Reyes, MD (Gyn/Ob) 011(507)65655041 oreyesmaternidad@gmail.com
Contact: Rodrigo Velarde, MD (Gyn/Ob) 011(507)66159954 revelarde_14@yahoo.es

Locations
Panama
Saint Thomas Maternity Hospital Recruiting
Panama, Panama
Contact: Osvaldo A Reyes, MD (Gyn/Ob)    011(507)65655041    oreyesmaternidad@gmail.com   
Contact: Rodrigo Velarde, MD (Gyn/Ob)    011(507)66159954    revelarde_14@yahoo.es   
Principal Investigator: Osvaldo A Reyes, MD (Gyn/Ob)         
Principal Investigator: Rodrigo Velarde, MD (Gyn/Ob)         
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
More Information
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Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01317225     History of Changes
Other Study ID Numbers: MHST2011-01
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: January 2015

Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Progesterone
Obstetric labor, premature
Short cervix

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
 Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists