Клинические исследование Преждевременные роды, Короткая длина шейки матки - Реестр клинических исследований

Обзор исследования

Статус

Завершенный

Условия

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Действительный)

89

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 50 лет (Взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Женский

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Количество групп / когорт

4

Когорты и вмешательства

Группа / когорта
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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Biomarkers Временное ограничение: 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

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Cervical sonographic changes Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Pittsburgh

Соавторы

University of Washington

University of Texas

Indiana University

RTI International

Следователи

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

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 августа 2013 г.

Первичное завершение (Действительный)

1 января 2015 г.

Завершение исследования (Действительный)

1 марта 2015 г.

Даты регистрации исследования

Первый отправленный

26 сентября 2013 г.

Впервые представлено, что соответствует критериям контроля качества