Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2015 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: January 3, 2015
Last verified: January 2015
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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:
- Incidence of preterm birth (before 37 weeks of gestation) [ Time Frame: 18 months ] [ Designated as safety issue: No ]Number of patients that delivered before 37 weeks of pregnancy
Secondary Outcome Measures:
- Incidence of preterm birth before 35 weeks of pregnancy [ 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 35 weeks of gestation in patients with a previous episode of threatened preterm labor.
- Incidence of preterm birth before 32 weeks of pregnancy [ 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.
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | Child, Adult, Senior |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317225
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
| 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: | January 3, 2015 |
| 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 Obstetric Labor Complications Premature Birth 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 |
ClinicalTrials.gov processed this record on September 26, 2016