Klinische proef op Vroeggeboorte, Korte cervicale lengte - Register voor klinische proeven

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

17-hydroxyprogesterone caproate (17-OHPC) has recently been shown to reduce the rate of recurrent preterm birth while intravaginal progesterone has been shown to reduce the rate of preterm birth in women with short cervix. While these interventions have reduced the rate of preterm birth, the mechanisms of action of these medications are unknown. The objective of this study is to collect and analyze blood and cervicovaginal fluids from pregnant women receiving these medications or other interventions such as cerclage, pessary, NSAIDs, and combinations thereof. The goal of the analyses is to assess the impact of these interventions on the cervical proteome, cervical cytokines and cervical structure and to identify potential biomarkers of response and non-response thus providing insights into the mechanisms of action of these drugs.

Studietype

Observationeel

Inschrijving (Werkelijk)

89

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- Indiana
  - Indianapolis, Indiana, Verenigde Staten, 46202
    - Indiana University School of Medicine
- Pennsylvania
  - Pittsburgh, Pennsylvania, Verenigde Staten, 15213
    - University of Pittsburgh
- Texas
  - Galveston, Texas, Verenigde Staten, 77555
    - University of Texas Medical Branch
- Washington
  - Seattle, Washington, Verenigde Staten, 98195
    - University of Washington

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

4

Cohorten en interventies

Groep / Cohort
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.
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.
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.
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Biomarkers Tijdsspanne: 2 Weeks	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.	2 Weeks

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Cervical sonographic changes Tijdsspanne: 8 Weeks	Changes in cervical sonographic gray scale density/length from weeks 0-2, 0-4, and 0-8 after the start of progestin therapy.	8 Weeks
Protein Expression Tijdsspanne: 8 Weeks	Proteins in the cervicovaginal fluid whose expression changes significantly from weeks 0-4 and 0-8 after the start of progestin therapy.	8 Weeks
Cervical cytokines Tijdsspanne: 8 Weeks	Changes in cervical cytokine inflammatory ratio weeks 0-2, 0-4, and 0-8 after the start of progestin therapy.	8 Weeks
Individual cytokines Tijdsspanne: 8 Weeks	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.	8 Weeks
Cervical MMPs Tijdsspanne: 8 Weeks	Changes in cervical MMPs 1, 2, 8 and 9 from weeks 0-2, 0-4, and 0-8 after the start of progestin therapy.	8 Weeks
Single nucleotide polymorphisms Tijdsspanne: 8 Weeks	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.	8 Weeks
Biomarkers Tijdsspanne: 8 Weeks	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.	8 Weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Pittsburgh

Medewerkers

University of Washington

University of Texas

Indiana University

RTI International

Onderzoekers

Hoofdonderzoeker: Steve Caritis, MD, University of Pittsburgh
Hoofdonderzoeker: David Flockhart, MD, PhD, Indiana University School of Medicine
Hoofdonderzoeker: Gary Hankins, MD, University of Texas
Hoofdonderzoeker: Mary F Hebert, PharmD, FCCP, University of Washington

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2013

Primaire voltooiing (Werkelijk)

1 januari 2015

Studie voltooiing (Werkelijk)

1 maart 2015

Studieregistratiedata

Eerst ingediend

26 september 2013

Eerst ingediend dat voldeed aan de QC-criteria