The Impact of Vaginal and IM Progestins on the Cervix
Determining the Pharmacodynamic Impact of Vaginal and IM Progestins on the Cervix
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 46202
- Indiana University School of Medicine
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Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
- University of Pittsburgh
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Texas
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Galveston, Texas, Vereinigte Staaten, 77555
- University of Texas Medical Branch
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Washington
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Seattle, Washington, Vereinigte Staaten, 98195
- University of Washington
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
This study consists of 4 groups of women who are between 16 0/7 - 23 6/7 weeks gestation. The allocation of a subject to a group is based on two objective assessments (history of preterm birth and cervical length) and the joint clinical decision of the woman and her physician regarding treatment options.
Study participants who have no prior preterm births and a normal cervical length will be assigned to Group 1. If the participant has no prior preterm births and a short cervical length, she will be assigned to Group 2 regardless of treatment or no treatment. Group assignment for women with a prior preterm birth and normal cervical length is based on 17-OHPC use. Participants who elect to use 17-OHPC will be assigned to Group 3 and those who choose not to receive any treatment will be assigned to Group 4.
Beschreibung
Inclusion Criteria
All Groups
- Singleton gestation (16 0/7 - 23 6/7 weeks gestation)
- Willing to provide informed consent
- Age 18 - 50 years inclusive
Additionally,
Group 1: One or more prior term births (>37 0/7 weeks); No prior spontaneous birth at 16 0/7 - 36 6/7 weeks; and normal cervical length (>25 mm)
Group 2: Cervical length of 20 mm or less at 16 0/7 - 23 6/7 weeks
Groups 3 and 4: History of prior spontaneous birth at 16 0/7 - 34 0/7 weeks and normal cervical length (> 25mm) at enrollment.
Exclusion Criteria
All Groups
- Active labor
- Active bleeding
- On progestin therapy, chronic steroid, or current NSAID therapy
- Actively receiving study treatment in another clinical trial (observational trials allowed)
- Major fetal malformation lethal anomalies, or anomalies that may lead to early delivery or increased risk of neonatal death e.g., gastroschisis, spina bifida, or serious karyotypic abnormalities
- Amniotic membranes prolapsed beyond the external os (ostium of uterus) or protruding into the vagina
- Pregnancy without a viable fetus
- Prenatal care or delivery planned elsewhere (unless the study visits can be made as scheduled and complete outcome information can be obtained)
Additionally:
Group 1: Cervical dilation greater than or equal to 3cm
Group 2: Prior preterm birth (16 0/7 - 34 0/7); active deep vein thrombosis, pulmonary embolism, or history of these conditions; known liver dysfunction or disease (active hepatitis, HIV)
Group 3: inability or unwillingness to use a 17-OHPC compounded product similar in composition to the FDA-approved product; allergy to 17-OHPC or its components
Groups 1, 3, and 4: cerclage in place or anticipated; congenital mullerian abnormality of the uterus; positive for bacterial vaginosis, chlamydia, gonorrhea, or trichomonas
Groups 3 and 4: current or history of thrombosis or thromboembolic disorders; known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding unrelated to pregnancy; cholestatic jaundice of pregnancy, liver tumors, benign or malignant, or active liver disease; uncontrolled hypertension
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Group 1: No prior preterm birth & normal cervix length
Pregnant women at 16 0/7 - 23 6/7 weeks gestation who have had one or more term births (no prior preterm births) and have a normal cervical length (> 25 mm).
These women will serve as gestational age controls for all groups.
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Group 2: No prior preterm birth & short cervix length
Pregnant women at 16 0/7 - 23 6/7 weeks gestation who have no prior preterm births and have a short cervical length (20mm or less).
These women may receive treatment (e.g.
vaginal progesterone, cerclage, pessary, NSAIDs, or a combination thereof) or no treatment.
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Group 3: Prior preterm birth, normal cervix length, 17-OHPC
Pregnant women at 16 0/7 - 23 6/7 weeks gestation who have had prior preterm birth, have a normal cervical length and will receive 17-OHPC treatment.
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Group 4: Prior preterm birth, normal cervix length, no treat
Pregnant women at 16 0/7 - 23 6/7 weeks gestation who have had prior preterm birth, have a normal cervical length, and will not receive any treatment.
These women will serve as controls for Group 3.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Biomarkers
Zeitfenster: 2 Weeks
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Proteins in the cervicovaginal fluid with expression changes two-fold or greater between day 0 and week 2 of either vaginal or IM progestin therapy.
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2 Weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Cervical sonographic changes
Zeitfenster: 8 Weeks
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Changes in cervical sonographic gray scale density/length from weeks 0-2, 0-4, and 0-8 after the start of progestin therapy.
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8 Weeks
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Protein Expression
Zeitfenster: 8 Weeks
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Proteins in the cervicovaginal fluid whose expression changes significantly from weeks 0-4 and 0-8 after the start of progestin therapy.
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8 Weeks
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Cervical cytokines
Zeitfenster: 8 Weeks
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Changes in cervical cytokine inflammatory ratio weeks 0-2, 0-4, and 0-8 after the start of progestin therapy.
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8 Weeks
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Individual cytokines
Zeitfenster: 8 Weeks
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Changes in individual cytokines (IL-1α, IL-1β, IL-1RA, IL-4, IL-6, IL-8, IL-10, IL-13, and TNF-α) from weeks 0-2, 0-4, and 0-8 after the start of progestin therapy.
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8 Weeks
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Cervical MMPs
Zeitfenster: 8 Weeks
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Changes in cervical MMPs 1, 2, 8 and 9 from weeks 0-2, 0-4, and 0-8 after the start of progestin therapy.
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8 Weeks
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Single nucleotide polymorphisms
Zeitfenster: 8 Weeks
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Test for association between single nucleotide polymorphisms (SNPs) in progestin and estrogen-related candidate genes and changes in the CVF proteome and cervical density and length.
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8 Weeks
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Biomarkers
Zeitfenster: 8 Weeks
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Proteins in the cervicovaginal fluid with expression changes two-fold or greater between weeks 0-4 and 0-8 of either vaginal or IM progestin therapy.
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8 Weeks
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Steve Caritis, MD, University of Pittsburgh
- Hauptermittler: David Flockhart, MD, PhD, Indiana University School of Medicine
- Hauptermittler: Gary Hankins, MD, University of Texas
- Hauptermittler: Mary F Hebert, PharmD, FCCP, University of Washington
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- OPRU Progestin
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