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Obstetric Labor, Premature clinical trials

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NCT ID: NCT06157203 Recruiting - Preterm Birth Clinical Trials

Labor Status Monitor for Diagnosing True vs False Labor in Preterm Patients

Start date: May 6, 2023
Phase:
Study type: Observational

This is an observational study of pregnant persons in threatened labor. The study device will record electromyography signals, then the signals will be examined to determine who is in true labor and who is in threatened labor. The two goals are: - To establish the thresholds for the Contraction Synchronization Index (CSI) and the False Labor Index (FSI) to be used by the Labor Status Monitor to diagnose in-Labor or Not-in-Labor for preterm patients with threatened labor - To obtain feedback from subjects and providers to assist with enhancing patient comfort and provider training.

NCT ID: NCT06053697 Recruiting - Preterm Birth Clinical Trials

Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?

SPRUCE
Start date: July 5, 2022
Phase:
Study type: Observational

The aim of this study is to try and find links between the microscopic organisms (such as bacteria, yeasts and viruses) in the vagina, and twin pregnancies that deliver too early (preterm birth). Being born earlier than expected (preterm birth) happens in over half of twin pregnancies with 1 in 10 sets of twins delivering before 32 weeks gestation. Sometimes, when birth happens very early, babies can be at risk of serious harm including damage to the brain, lungs and bowel - all of which can result in life changing disabilities. How severe these problems are is related to how early they are born. Unfortunately, tests used to find women at risk of preterm birth have only been proven to work when the woman is carrying one baby, not twins, and at present no treatment has been shown to be effective in stopping a twin pregnancy from delivering early. Preventing twins from being born too early is therefore a target for research by the NHS and patient groups including the James Lind Alliance. It is normal for every woman to have microscopic organisms (such as bacteria, yeasts and viruses) in the vagina. New interest has been shown at looking closely at these organisms during pregnancy. These organisms can change and may be related to the number of weeks a woman will go into labour, however to date all research on this has been conducted in pregnancies with only one baby. We want to explore these organisms in twin pregnancies; taking swabs from the vagina at 16- and 28-weeks of your pregnancy, along with at the time of birth. Information will be gathered on the organisms present in the vagina (both of women that deliver too early and those that deliver on time), hoping this information will help us understand why preterm birth happens and help predict the chances of preterm labour in twin pregnancies. By identifying specific organisms linked with preterm birth, we also hope to be able to guide new targets for treatments to prevent preterm birth in twins in future. Due to the small number of twin pregnancies, measurements of how 'stiff' the neck of the womb (cervix) are along with blood samples will be taken. Research has shown that there may be links with how stiff the neck of the womb is and premature birth as well as markers within the blood that may help us predict preterm birth that are yet to be discovered. This will provide the foundations for a future research study.

NCT ID: NCT05997563 Recruiting - Preterm Labor Clinical Trials

Adjunctive Vaginal Progesterone in Management of Preterm Labor

Start date: August 16, 2023
Phase: Phase 4
Study type: Interventional

This study evaluates the addition of vaginal micronized progesterone effervescent to standard treatment in the treatment of preterm labor. Half of participants will receive vaginal micronized progesterone effervescent and standard treatment, while the other half will receive only standard treatment.

NCT ID: NCT05994443 Recruiting - Preterm Labor Clinical Trials

Fetal Brain Growth - Pilot Study

Start date: June 8, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational prospective study is to explore the feasibility of measuring fetal and neonatal brain growth using 2D and 3D ultrasound in fetuses exposed to threatened preterm labor (TPTL) and antenatal corticosteroids (ACS) compared to non-exposed fetuses. Patients with singleton pregnancies on our site with repeated ultrasound measurements every 4 weeks will be evaluated for fetal brain development. The exposed group is defined as patients with a dual exposure of TPTL and ACS. The non-exposed group will be composed of patients who did not have TPTL and ACS. Therefore, patients will have a maximum of 5 additional visits (4 that will occur prenatally and 1 postnatal visit).

NCT ID: NCT05742997 Recruiting - Preterm Birth Clinical Trials

Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth in Women Presenting With Signs and Symptoms of Preterm Labor

PartoSure
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Currently, the American College of Obstetricians and Gynecologists (ACOG) indicate in their most recent Practice Bulletin on the Management of Preterm Labor that many tests to identify women at risk of preterm birth have been proposed and evaluated; however, only ultrasonography and fetal fibronectin testing have been shown to have benefit. Ultrasonography to determine cervical length, fetal fibronectin testing, or a combination of both may be useful in determining which women are at high risk for preterm delivery. However, their clinical usefulness may rest primarily with their ability to identify women who are least likely to deliver (i.e. their negative predictive value). Therefore, there is an urgent need for a test with a high positive predictive value in order to accurately predict imminent delivery to allow for salutary intervention.

NCT ID: NCT05698966 Recruiting - Preterm Labor Clinical Trials

Low Dose Antenatal Corticosteroids for Late Preterm Delivery

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

This is a study proposal for a clinical trial to evaluate the effectiveness of a reduced dose of antenatal betamethasone (a steroid medication) in preventing respiratory problems in late preterm infants (born between 34 and 36 weeks of gestation). The study will be conducted in medical centers in Israel and will involve women who are at high risk for delivering a late preterm infant. The participants will be randomly assigned to receive either a full dose (12 mg) or a quarter dose (3 mg) of betamethasone, administered 24 hours apart. The main outcome measure of the study will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in the two groups. The study is designed to determine if the reduced dose of betamethasone is non-inferior (i.e., not significantly worse) than the full dose in preventing respiratory problems in late preterm infants.

NCT ID: NCT05685745 Recruiting - Premature Birth Clinical Trials

Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset

Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals.

NCT ID: NCT05670665 Recruiting - Clinical trials for Obstetric Labor, Premature

Impact of Threatened Preterm Labour in Fetal Cardiovascular and Metabolic Programming (SHs)

SHs
Start date: June 22, 2020
Phase:
Study type: Observational

The goal of this observational study is to learn about cardiac function and remodelling and metabolomic profiles in fetuses and infants who were exposed to a threatened preterm labor (TPL) during pregnancy.

NCT ID: NCT05602883 Recruiting - Sleep Quality Clinical Trials

Music Therapy in the Threat of Premature Birth

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

The scope of the study covers the effects of music therapy on risk perception levels and sleep quality in pregnant women hospitalized due to the diagnosis of premature birth threat.

NCT ID: NCT05586334 Recruiting - Preterm Labor Clinical Trials

Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth (PrediMAP)

PrediMAP
Start date: June 8, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to clinically validate the predictive performance (sensitivity and specificity) of the PrediMAP in-vitro diagnostic medical device to predict delivery within 7 days in the target population of women consulting obstetric emergencies for preterm labor (PTL).