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Cervical Incompetence clinical trials

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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: NCT05268640 Recruiting - Clinical trials for Cervical Incompetence

Cervical Occlusion Double-level Stitch Application

COSA
Start date: March 11, 2022
Phase: N/A
Study type: Interventional

Cervical insufficiency is defined as painless dilatation of the cervix during the second trimester of pregnancy. As a result of shortening and opening of the cervix, despite the lack of uterine contractions, the fetal membranes invade into the cervical canal and then into the vagina, which results in premature rupture of the membranes and miscarriage or preterm delivery. Cervical insufficiency occurs in approximately 1% of the women. The aim of the study is to evaluate the effectiveness of placing a double-level cervical cerclage in the treatment of advanced cervical insufficiency. The hypothesis assumes that the insertion of a double-level suture is associated with a reduction in the rate of deliveries < 34 weeks of gestation in comparison to single-level suture. The study will include women with fetal membranes visible through open external os of the cervix between 16+0 and 23+6 weeks. They will be randomized to two arms - McDonald's single cervical cerclage or two-level cerclage.

NCT ID: NCT03992534 Recruiting - Preterm Birth Clinical Trials

The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth

Start date: September 16, 2019
Phase: Phase 1
Study type: Interventional

Preterm birth (PTB) is the primary cause of infant death worldwide. It has been shown that a vaginal microbiota deplete in Lactobacillus species is a risk factor for preterm labour. Conversely a vaginal microbiota dominated by Lactobacillus crispatus appears to be protective for these adverse outcomes. A wide range of 'over the counter' Lactobacillus spp. containing products targeted at 'vaginal health' and formulated for vaginal administration are available, but most of them do not contain vaginal species of Lactobacillus. The primary aim of this study is to determine whether vaginal supplementation with L. crispatus CTV-05 is associated with colonisation.

NCT ID: NCT03837288 Recruiting - Preterm Labor Clinical Trials

Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening

Start date: April 22, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to Determine whether cerclage with vaginal progesterone will: 1. Reduce the overall spontaneous preterm birth rate. 2. Prolong pregnancy latency. 3. Improve neonatal outcome. Compared to vaginal progesterone only, in patients with progressive cervical shortening. Research question: Does cervical cerclage reduce the overall spontaneous preterm births in patients with progressive cervical shortening. Research Hypothesis In this current study, the investigators hypothesize that cervical cerclage reduces spontaneous preterm births in patients with progressive cervical shortening on vaginal progesterone only.

NCT ID: NCT03636048 Terminated - Clinical trials for Cervical Incompetence

Comparison of Anesthesia Type in Patients Undergoing Transabdominal Cervico Isthmic Cerclage (TCIC)

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

The investigator aimed to compare the effect of anesthesia on overall postoperative outcomes including post-operative pain score and the fetal well-being (heart rate) in patients undergoing transabdominal cervico isthmic cerclage(TCIC). The investigator divided the patients into two groups. The first group was the patients who undergo general anesthesia with postoperative wound patient-controlled analgesia device(PCA) and the second group was the patients who undergo combined spinal-epidural anesthesia(CSE) with postoperative epidural catheter PCA device for pain control.

NCT ID: NCT03311867 Completed - Clinical trials for Cervical Incompetence

Prolene Versus Ethibond for Cervical Cerclage

PECC
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

The purpose of the proposed study is to examine the relationship between cerclage suture material of Ethibond and Prolene and its effect on the vaginal microbiome in a prospective randomized control trial. Ethibond is another commonly used suture material for performing cervical cerclage that shares some characteristics with previously studied suture materials. It is braided like the Mersilene, but thinner like the monofilament Prolene. The investigators will study whether Ethibond causes the vaginal microbiome to be adversely affected like Mersilene or whether there is a healthy microbiome like Prolene. This study will allow the investigators to determine whether it is advisable to continue to use Ethibond for cervical cerclage in clinical practice, or whether obstetricians should avoid its use as now done with Mersilene.

NCT ID: NCT03305575 Completed - Clinical trials for Cervical Incompetence

Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage

Start date: October 13, 2017
Phase: Phase 4
Study type: Interventional

This study aims to compare the effect of chloroprocaine vs. bupivacaine on duration of motor block and duration until meeting discharge criteria in patients undergoing cervical cerclage. The hypothesis is that chloroprocaine will result in faster resolution of motor block.

NCT ID: NCT03077633 Withdrawn - Preterm Birth Clinical Trials

Cerclage for Twins With Short Cervix

Start date: October 1, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

A prospective randomized control trial that will compare cervical cerclage plus vaginal progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix (</= 15.0mm) between 16w0d to 25w6d.