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Short Cervix clinical trials

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NCT ID: NCT06463652 Not yet recruiting - Preterm Birth Clinical Trials

Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies

RESILIENT
Start date: June 2024
Phase: N/A
Study type: Interventional

This study compares the effectiveness of cervical cerclage with vaginal progesterone to vaginal progesterone only for the prevention of preterm birth in women with a singleton pregnancy and a short cervical length. Participants will be randomly assigned in a 1:1 ratio to receive cerclage plus progesterone or progesterone only.

NCT ID: NCT05512052 Not yet recruiting - Preterm Birth Clinical Trials

Preventing Preterm Birth With a Negative Pressure Cervical Cup: a Feasibility Study

Start date: April 2023
Phase: Phase 1
Study type: Interventional

The goal of this Phase I clinical trial is to generate proof-of-concept data to demonstrate that a cervical cup in combination with vacuum application will create negative pressure on uterine cervical tissue, thereby creating immediate cervical stiffness in order to prevent cervical ripening that is associated with spontaneous preterm birth. Aim #1: Conduct a Phase I clinical study. 1A: Evaluate the ability of a cervical cup to improve cervical tissue physiology of uterine cervices in vivo for nonpregnant women. 1B: Evaluate the ability of a cervical cup to be safely placed and removed on uterine cervices in vivo for nonpregnant women.

NCT ID: NCT04300322 Recruiting - Preterm Birth Clinical Trials

Pessary Versus Progesterone in Singletons

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

This study compares the effectiveness of cervical pessary to vaginal progesterone for prevention of preterm birth in women with singleton pregnancies and a cervix ≤25 mm. Participants will be randomly assigned in a 1:1 ratio to receive cervical pessary or vaginal progesterone.

NCT ID: NCT03863613 Terminated - Preterm Birth Clinical Trials

Pessary Versus Cerclage With or Without Progesterone in Twins

PCP-Twins
Start date: March 23, 2019
Phase: N/A
Study type: Interventional

This study compares the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone for prevention of preterm birth in women with a twin pregnancy and a cervix ≤28 mm. Participants will be randomly assigned in a 1:1:1:1 ratio to receive cerclage, pessary, cerclage plus progesterone or pessary plus progesterone.

NCT ID: NCT03340688 Recruiting - Preterm Birth Clinical Trials

Cerclage for Twins With Short Cervical Length ≤ 15mm

TWIN-UIC
Start date: June 22, 2017
Phase: N/A
Study type: Interventional

This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.

NCT ID: NCT03227705 Completed - Preterm Birth Clinical Trials

Canadian Study on the Association of Pessary With Progesterone

CAPP
Start date: June 4, 2018
Phase: N/A
Study type: Interventional

Prematurity is the leading cause of neonatal morbidity causing more than 1 million deaths worldwide per year. In 2012, a randomized controlled trial (RCT) testing "pessary" (silicone ring placed around the cervix) versus "no pessary" in patients with a short cervix showed a 4-fold reduction in the rate of spontaneous prematurity <34 weeks of gestation and a reduction in perinatal morbidity and mortality. This result was not found in a subsequent RCT and another study on the subject had to be stopped in the face of slow recruitment. Currently, the obstetric scientific community believes that other RCTs are needed before using the pessary in the clinic as a therapeutic option to prevent prematurity in the presence of a short cervix. However, before starting a large RCT, it is important to test the feasibility of recruitment.

NCT ID: NCT03022591 Completed - Short Cervix Clinical Trials

Short Cervix - Twins

Start date: January 2017
Phase: N/A
Study type: Observational

This is a retrospective chart review. The purpose of this study will be to look at the outcomes of twin pregnancies diagnosed with short cervix along with the intervention (treatment) that these patients received.

NCT ID: NCT02901626 Terminated - Preterm Delivery Clinical Trials

A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix

TOPS
Start date: February 14, 2017
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether the Arabin pessary is a useful intervention of preterm birth at less than 37 weeks in women with a singleton gestation and a short cervix.

NCT ID: NCT02470676 Not yet recruiting - Preterm Birth Clinical Trials

Cervical Pessary vs Vaginal Progesterone in Preventing Preterm Birth Among Women Presenting With Short Cervix: An Open-label Randomized Controlled Trial

Start date: July 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this randomized control trial is to determine whether cervical pessary plus vaginal progesterone is superior to vaginal progesterone alone in decreasing preterm delivery rate, and improving perinatal outcome, among women presenting with an asymptomatic mid-pregnancy short cervix, in singleton and twin gestations. All women with singleton or twin pregnancies undergoing routine ultrasonography up to 24 completed weeks of gestation (for examination of fetal anatomy and growth) and diagnosed with cervical length of ≤25 mm in singleton, or ≤38 mm in twins, will be invited to participate in the clinical trial. Women who meet eligible criteria will be invited to participate in the clinical trial. Women will be randomly assigned into one of the following groups: group A (vaginal progesterone) or group B (vaginal progesterone + pessary). Follow-up visits for ultrasound assessment of fetal growth and cervical length will be carried out every two weeks until 37 weeks of gestation.

NCT ID: NCT02056652 Completed - Preterm Birth Clinical Trials

Prevention of Preterm Birth With a Pessary in Singleton Gestations

PoPPS
Start date: February 2014
Phase: N/A
Study type: Interventional

Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually. The rate of PTB in the United States increased to 12.8% in 2006, and remains high compared to almost all other developed countries, despite the introduction of many public health and medical interventions designed to delay PTB. Weekly treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has been shown to significantly reduce the risk of PTB and is currently recommended for women who experienced spontaneous PTB in a prior pregnancy. However, a strategy for the prevention of spontaneous PTBs in which therapeutic intervention is restricted to women with a previous PTB is likely to have a small effect on the overall rate of prematurity since only about 10% of spontaneous PTBs arise in women with such a history. A major reduction in rates of mortality and morbidity in premature babies will only be achieved with increased precision in the identification of women at risk of spontaneous PTB and through the development of an effective prevention for this complication. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. Although treatment with vaginal progesterone is effective in decreasing PTB in women with a short cervix, over 30% of women still experience premature delivery and many women find daily administration of progesterone to be challenging. Preliminary studies have suggested that use of an intravaginal pessary may be effective in preventing PTB. If effective this approach would be particularly appealing because of the wide availability of pessaries, ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm effectiveness; a well designed, properly powered, prospective randomized trial is warranted prior to widespread implementation in clinical practice. We propose such a trial to study the effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia population.