Trial record 1 of 114 for:
Open Studies | "Obstetric Labor, Premature"
Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone
This study is currently recruiting participants.
Verified July 2012 by Saint Thomas Hospital, Panama
Sponsor:
Saint Thomas Hospital, Panama
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01317225
First received: March 16, 2011
Last updated: July 26, 2012
Last verified: July 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Preterm Birth Obstetric Labor, Premature |
Drug: 17 α hydroxyprogesterone caproate Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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. |
Resource links provided by NLM:
Further study details as provided by Saint Thomas Hospital, Panama:
Primary Outcome Measures:
- To determine if the use of 17 α hydroxyprogesterone caproate can reduce the incidence of preterm birth before 37 weeks of gestation in patients with a previous episode of threatened preterm labor. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Progesterone |
Drug: 17 α hydroxyprogesterone caproate
250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.
Other Name: 17 α hydroxyprogesterone caproate
|
| Placebo Comparator: Placebo |
Drug: Placebo
250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.
Other Name: Saline solution
|
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.
Eligibility| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama |
| ClinicalTrials.gov Identifier: | NCT01317225 History of Changes |
| Other Study ID Numbers: | MHST2011-01 |
| Study First Received: | March 16, 2011 |
| Last Updated: | July 26, 2012 |
| Health Authority: | Panama: Ministry of Health |
Keywords provided by Saint Thomas Hospital, Panama:
|
Progesterone Obstetric labor, premature Short cervix |
Additional relevant MeSH terms:
|
Obstetric Labor, Premature Premature Birth Obstetric Labor Complications Pregnancy Complications 17-alpha-hydroxy-progesterone caproate 11-hydroxyprogesterone Progesterone Progestins |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Estradiol Antagonists Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013