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Cervix; Pregnancy clinical trials

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NCT ID: NCT06339606 Not yet recruiting - Pregnancy Related Clinical Trials

Pregnancy Repository

PR
Start date: May 1, 2024
Phase:
Study type: Observational [Patient Registry]

An essential part of clinical research is the availability and accessibility of human biospecimens for the identification of biomarkers, new treatments and measurement of response to therapy. Proteins, RNA and DNA can be extracted and studied as well. This is a critical first step in performing many fundamental molecular biology experiments. A variety of biospecimens are utilized for research including but not limited to normal and malignant tissues, blood, and other body fluids. In order to obtain high-quality biospecimens, they must be acquired serially, stored according to current standards, and matched with clinical information for maximum value. As such, the investigators would like to create a repository of biospecimens collected from pregnant patients who are seen at Mount Sinai Hospital and other research hospitals in Toronto. Mount Sinai provides personnel and infrastructure to serve the largest (7500 births/year) and highest complex Maternity program in Ontario. Of the 7500 patients a year, at least 2500 are considered high risk pregnancies, where there's a possibility of preeclampsia, placenta accreta and a host of other complications. For this study, biological specimens - blood, cervical and placental samples - will be collected from these high-risk groups in order to better understand the causes of the underlying conditions.

NCT ID: NCT06323187 Not yet recruiting - Preeclampsia Clinical Trials

Optimization of Cervical Collections in Pregnancy

OCCP
Start date: May 1, 2024
Phase:
Study type: Observational [Patient Registry]

Fetal cells are not easily obtained from pregnant patients; this curtails testing to assess the health of the fetus and the mother. Currently, the only way of diagnosing fetal genetic or chromosomal abnormalities is by invasive techniques, such as chorionic villous sampling (CVS) and amniocentesis performed at 10 to 13 weeks and after 15 weeks of gestation, respectively. Although small, there is a risk for fetal loss with these procedures. Transcervical cell sampling (TCS), similar to a Pap smear, is a platform that meets the requirements for prenatal genetic testing (genetic testing with fetal cells obtained before birth), as well as diagnosis of maternal pregnancy complication, at a very early stage of pregnancy (as early as 5 weeks) and carries low risk for the mother and the developing fetus. This study will examine cervical fluid collected using various noninvasive methods for TCS in pregnant women. The number of placental cells will be assessed against similarly obtained samples from nonpregnant women of reproductive age who lack cells derived from a placenta. Participating volunteers will provide written informed consent. Only standard medical procedures and approved devices will be used for collection of cervical fluid, minimizing risk to the participants and their fetuses. No test results or other benefits will be available to the participants.

NCT ID: NCT05858775 Recruiting - Cervix; Pregnancy Clinical Trials

Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation

MAPVIX
Start date: July 5, 2023
Phase:
Study type: Observational

The assessment of cervical stiffness plays a major role in obstetrics, for example to assess the risk of preterm birth. The Pregnolia System is a CE-certified measuring device that objectively determines cervical stiffness using a slight negative pressure. The Pregnolia System was developed in Switzerland and resulted from a research project of the ETH and the University Hospital Zurich. Until now, the stiffness of the cervix was examined and individually assessed by palpation (palpation with fingers). The Pregnolia System was developed to make this measurement objective and independent of the examining person. The aim of the study is to measure cervical stiffness at different locations on the cervix to see if there are differences between the measurement locations.

NCT ID: NCT05306405 Recruiting - Cervix; Pregnancy Clinical Trials

Comparative Study Between Only Vaginal Misoprostol and Vaginal Misoprostol and Estradiol Cream

Start date: February 20, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

To compare the safety and effectiveness of vaginal misoprostol with combined vaginal misoprostol and estradiol for induction of labour in unfavorable cervix

NCT ID: NCT05260333 Completed - Cervix; Pregnancy Clinical Trials

Sound Check-Correlation Between Transperineal and Digital Cervical Exam in 3rd Trimester Pregnancy

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The primary purpose of this study is to compare the accuracy of the Butterfly iQ pocket ultrasound with the digital cervical examination in the third trimester cervix. The secondary aim of this study is to compare discomfort or the two cervical exam methods and determine if patients have a preference for one over the other.

NCT ID: NCT05246579 Recruiting - Preterm Birth Clinical Trials

Prospective Evaluation of Pathways for Preterm Birth

PEPP
Start date: February 14, 2022
Phase:
Study type: Observational

This is a single center, prospective cohort study of pregnant patients at high risk for spontaneous preterm birth: patient's with history of spontaneous preterm birth, patient's with a short cervix and patient's symptomatic for preterm birth will be included. A control cohort of nulliparous patients without a short cervix will be recruited to provide baseline data. Plan to enroll 240 patients identified through our ultrasound unit with goal of 60 patients in each group.

NCT ID: NCT05200117 Completed - Cervix; Pregnancy Clinical Trials

Pregnolia System Intra-observer Variability

Start date: January 12, 2022
Phase:
Study type: Observational

The Pregnolia System is a CE-marked medical device assessing the mechanical stiffness of cervical tissue in women. The Pregnolia Probe has been engineered to minimize the influence of differences in handling and technique by the user. This project aims to study intra-observer variability of the Pregnolia System in pregnant women in the clinical setting. Furthermore, a same day repeated measurement serves to investigate the time period needed to recover the pre-measurement stiffness state due to viscoelasticity of the cervical tissue.

NCT ID: NCT04444206 Recruiting - Preterm Birth Clinical Trials

Prevention of Preterm Birth by Screening of the Consistency Index and Length of the Uterine Cervix in Women With a Single Pregnancy

PreBirthCerv
Start date: April 25, 2020
Phase: N/A
Study type: Interventional

Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB. Other strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix. However, the predictive value of the research has recently been questioned, as the threat rate from preterms in the low-risk population has not decreased over time. Numerous clinical studies have been conducted to improve and identify effective prevention strategies in the threat of preterm birth. Among the parameters studied, in addition to the measurement of the uterine cervix and its complaints during the three trimesters of pregnancy, an evaluation of the cervical consistency index (CCI) was also proposed, i.e. an ultrasound evaluation of cervical softness.

NCT ID: NCT04421768 Recruiting - Pregnancy Related Clinical Trials

Effects of Systematic Cervical Exam Training on Labor and Delivery Care

Start date: July 23, 2020
Phase: N/A
Study type: Interventional

All physicians, nurses, and nurse midwives working on Labor and Delivery will be required to complete cervical exam simulation training. Data before and after institution of the training will be compared to determine if the training leads to less cervical exams during labor and increases consistency between examiners

NCT ID: NCT03472066 Recruiting - Cervix; Pregnancy Clinical Trials

Measurement of the Cervix During Pregnancy According to Age of Conization

MesCon
Start date: February 19, 2018
Phase:
Study type: Observational

Treatment of precancerous lesions of the cervix by conization has been shown to increase the risk of premature delivery and premature rupture of the membranes. It has now been clearly established that the cervix is a growing organ during adolescence and early adulthood, It has been hypothetized that cervical conization during the growth phase reduced its growth potential, and induced shorter cervix during the upcoming pregnancy. No studies have been conducted investigating the age at which conization no longer had an impact on cervical size during pregnancy. This will help to identify the age at conisation below which patients will be identified as being at risk event, and thus offer increased monitoring and possibly prophylactic management by programmed strapping. We propose to measure the length of the cervix of pregnant patients who have benefited from conization, which is currently recommended by the Collège National des Gynécologues Obstetriciens Français .In addition, the investigators will use a control group consisting of non-con conical, parity-matched pregnant patients in whom a cervical measurement will also be performed.