早産、短い子宮頸管の長さの臨床試験-臨床試験登録-ICH GCP

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

89

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

アメリカ
- Indiana
  - Indianapolis、Indiana、アメリカ、46202
    - Indiana University School of Medicine
- Pennsylvania
  - Pittsburgh、Pennsylvania、アメリカ、15213
    - University of Pittsburgh
- Texas
  - Galveston、Texas、アメリカ、77555
    - University of Texas Medical Branch
- Washington
  - Seattle、Washington、アメリカ、98195
    - University of Washington

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～50年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

4

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Biomarkers 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Cervical sonographic changes 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Pittsburgh

協力者

University of Washington

University of Texas

Indiana University

RTI International

捜査官

主任研究者：Steve Caritis, MD、University of Pittsburgh
主任研究者：David Flockhart, MD, PhD、Indiana University School of Medicine
主任研究者：Gary Hankins, MD、University of Texas
主任研究者：Mary F Hebert, PharmD, FCCP、University of Washington

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年8月1日

一次修了 (実際)

2015年1月1日

研究の完了 (実際)

2015年3月1日

試験登録日

最初に提出

2013年9月26日

QC基準を満たした最初の提出物