Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone
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.
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2011
CompletedFirst Posted
Study publicly available on registry
March 17, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJanuary 6, 2015
January 1, 2015
4.1 years
March 16, 2011
January 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of preterm birth (before 37 weeks of gestation)
Number of patients that delivered before 37 weeks of pregnancy
18 months
Secondary Outcomes (2)
Incidence of preterm birth before 35 weeks of pregnancy
18 months
Incidence of preterm birth before 32 weeks of pregnancy
18 months
Study Arms (2)
17 α hydroxyprogesterone caproate
EXPERIMENTAL17α-Hydroxyprogesterone caproate.
Placebo
PLACEBO COMPARATORSaline solution.
Interventions
250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.
250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.
Eligibility Criteria
You may qualify if:
- Pregnant women between 26 and 34 weeks of gestation.
- Cervical length (determined by transvaginal ultrasound) below the 10th percentile for the gestational age.
You may not qualify if:
- Multiple gestations.
- Maternal pathologies in which preterm termination of pregnancy is required.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Thomas Maternity Hospital
Panama City, Provincia de Panamá, Panama
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Osvaldo A Reyes, MD (Gyn/Ob)
Saint Thomas Maternity Hospital
- PRINCIPAL INVESTIGATOR
Rodrigo Velarde, MD (Gyn/Ob)
Saint Thomas Maternity Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 16, 2011
First Posted
March 17, 2011
Study Start
June 1, 2011
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
January 6, 2015
Record last verified: 2015-01