A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
Public ClinicalTrials.gov record NCT02377466. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study's primary objective is to demonstrate the superiority of retosiban to prolong pregnancy and improve neonatal outcomes compared with placebo. It is a Phase III, randomized, double-blind, parallel-group, multicenter study and will be conducted in approximately 900 females, aged 12 to 45 years, with an uncomplicated, singleton pregnancy and intact membranes in preterm labor between 24\^0/7 and 33\^6/7 weeks of gestation. Eligible maternal subjects will be randomly assigned in a 1:1 ratio to receive either retosiban IV infusion or placebo IV infusion over 48 hours. If not previously administered, antenatal corticosteroid treatment should be administered as either (1) two 12-mg doses of betamethasone given intramuscularly 24 hours apart or (2) four 6-mg doses of betamethasone administered intramuscularly every 12 hours. A single rescue course of antenatal corticosteroids is permitted if the antecedent treatment was at least 7 days prior to study enrolment. Investigators have discretion to use a standardized regimen of magnesium sulphate, as well as intrapartum antibiotic prophylaxis for perinatal group B streptococcal infection. Prior to randomization, each subject will be stratified by progesterone treatment and gestational age. The progesterone strata will consist of subjects on established progesterone therapy or subjects not on established progesterone therapy at Screening. The study will comprise 6 phases: Screening, Inpatient Randomized Treatment, Post Infusion Assessment, Delivery, Maternal Post-Delivery Assessment, and Neonatal Medical Review. The duration of any subject's (maternal or neonatal) participation in the study will be variable and dependent on gestational ages (GA) at study entry and the date of delivery.
Study identification
- NCT ID
- NCT02377466
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2016
- Primary completion
- Jul 23, 2017
- Completion
- Jul 23, 2017
- Last update posted
- Jul 27, 2020
2016 – 2017
United States locations
- U.S. sites
- 33
- U.S. states
- 23
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35233 | — |
| GSK Investigational Site | Mobile | Alabama | 36604 | — |
| GSK Investigational Site | Tucson | Arizona | 85712 | — |
| GSK Investigational Site | Colton | California | 92324 | — |
| GSK Investigational Site | Orange | California | 92868 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20010 | — |
| GSK Investigational Site | Jacksonville | Florida | 32209 | — |
| GSK Investigational Site | Augusta | Georgia | 30912 | — |
| GSK Investigational Site | Columbus | Georgia | 31904 | — |
| GSK Investigational Site | Chicago | Illinois | 60611 | — |
| GSK Investigational Site | Chicago | Illinois | 60637 | — |
| GSK Investigational Site | Maywood | Illinois | 60153 | — |
| GSK Investigational Site | Park Ridge | Illinois | 60068 | — |
| GSK Investigational Site | Kansas City | Kansas | 66160 | — |
| GSK Investigational Site | Louisville | Kentucky | 40202 | — |
| GSK Investigational Site | New Orleans | Louisiana | 70115 | — |
| GSK Investigational Site | Jackson | Mississippi | 39216-4505 | — |
| GSK Investigational Site | Richmond Heights | Missouri | 63117 | — |
| GSK Investigational Site | Neptune City | New Jersey | 07753 | — |
| GSK Investigational Site | Newark | New Jersey | 07103 | — |
| GSK Investigational Site | Brooklyn | New York | 11201 | — |
| GSK Investigational Site | New York | New York | 10032 | — |
| GSK Investigational Site | The Bronx | New York | 10461 | — |
| GSK Investigational Site | Durham | North Carolina | 27710 | — |
| GSK Investigational Site | Cleveland | Ohio | 44106 | — |
| GSK Investigational Site | Dayton | Ohio | 45409 | — |
| GSK Investigational Site | Portland | Oregon | 97239 | — |
| GSK Investigational Site | Lancaster | Pennsylvania | 17601 | — |
| GSK Investigational Site | Charleston | South Carolina | 29425 | — |
| GSK Investigational Site | Chattanooga | Tennessee | 37403 | — |
| GSK Investigational Site | Galveston | Texas | 77555-0587 | — |
| GSK Investigational Site | Charlottesville | Virginia | 22908 | — |
| GSK Investigational Site | Tacoma | Washington | 98431 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02377466, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 27, 2020 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02377466 live on ClinicalTrials.gov.