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Preterm Labor clinical trials

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NCT ID: NCT03401255 Completed - Preterm Birth Clinical Trials

Interest of a Vaginal Swab in Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth

MAPOSURE
Start date: February 28, 2018
Phase:
Study type: Observational

Preterm labor is the first cause of hospitalization during the pregnancy, and at the origin of more than 60 000 births before 37 weeks of amenorrhea every year in France. It is however difficult to predict if a patient consulting in emergencies with symptoms of preterm labor, will give birth prematurely or not. Current diagnostic tools to identify patients with high risk of premature delivery in 7 days are insufficient because of their low positive predictive value. Yet the neonatal complications in case of premature delivery are important, with respiratory distress syndrome, hyaline membrane disease, necrotizing enterocolitis, intraventricular hemorrhage and post-natal death. Recent studies suggested that the detection of the placental alpha microglobulin 1 (PAMG-1) in the vaginal secretions, by Partosure® test at the women presenting symptoms of preterm labor with intact membranes would indicate that a premature spontaneous delivery could arise in 7 days with a good positive predictive value.The test is interesting all the more as the repetition of the prenatal cures of corticosteroids, aiming at the fetal lung maturation, is this day more recommended and as the beneficial effect takes place within 24 hours in 7 days following their administration. It seems thus essential to make studies to specify the interest of this test at the patients presenting a preterm labor. This study aims at estimating the diagnostic performance of the test of detection of PAMG-1 in the prediction of a delivery in 7 days, at the patients presenting symptoms of preterm labor.

NCT ID: NCT03369262 Active, not recruiting - Preterm Labor Clinical Trials

PoC Study of OBE022 in Threatened Preterm Labour

PROLONG
Start date: January 10, 2018
Phase: Phase 2
Study type: Interventional

This is a proof-of-concept study in 2 parts. In Part A, patients will receive OBE022 open-label in order to assess the safety and pharmacokinetics in pregnant women with spontaneous preterm labour with a gestational age between 28 0/7 and 33 6/7 weeks. Part B has a double-blind, randomised, placebo controlled, parallel group and multicentre design and will assess the efficacy, safety and pharmacokinetics in pregnant women with threatened spontaneous preterm labour with a gestational age between 24 0/7 and 33 6/7 weeks. All patients in part A and part B must receive atosiban infusion for 48 hours as standard of care treatment. Patients from Part A will receive OBE022 open label. Patients from Part B will be randomised to receive OBE022 or matching placebo. IMP treatment duration will be up to 7 days. IMP treatment will be stopped in case of delivery prior to Day 7.

NCT ID: NCT03343795 Completed - Preterm Labor Clinical Trials

Oral Versus Parental Progesterone in the Management of Preterm Labor

Start date: July 5, 2017
Phase: Phase 4
Study type: Interventional

Preterm birth, defined as delivery at less than 37 weeks gestation, complicates approximately 12% of pregnancies in the United States Preterm delivery has been, and remains, the most important challenge to modern obstetrics. In 2009, 13 million babies were born preterm, 11 million in Africa and Asia and 500,000 in the USA, The highest rates of preterm birth are in Africa (11.9%) and North America (10.6%)

NCT ID: NCT03334877 Completed - Preterm Labor Clinical Trials

Prediction of Preterm Labor in Asymptomatic High Risk Women

Start date: May 15, 2015
Phase: N/A
Study type: Observational

Two hundred and twenty women with singleton pregnancies and risk factors for spontaneous preterm birth were included in this study. Cervico vaginal fluid sampling was undertaken for qualitative assessment of β -human chorionic gonadotropin (β-hCG) and fetal fibronectin(fFN)at 24 weeks of gestation. For qualitative assay of both b-hCG and fFN, first vaginal specimens were collected by the following method: Specimen collection A sterile Cusco speculum was introduced into the vagina; the anterior lip of the cervix was grasped with sponge forceps and a cotton-tipped swab was placed into the external part of the endocervical canal (not reaching the internal os) and then into the posterior fornix (each for at least 1 min) to obtain an adequate sample of cervico vaginal secretions. Sampling was performed before doing any cervical manipulation (digital or ultrasound examination) and before introducing any vaginal material (lubricants or medications). The Hologic Specimen Collection Kit is the only acceptable specimen collection system which can be used to collect specimens for this assay. The polyester tipped swab provided in the Specimen Collection Kit should be inserted into the vagina and lightly rotated across the posterior fornix for approximately 10 seconds to absorb the cervico vaginal secretions. Once the specimen is obtained, carefully remove the swab from the vagina and place it into the tube of buffer provided with the Specimen Collection Kit. Two Specimen Collection Device per patient were obtained; one for each assay. Label the Specimen Transport Tubes with the patient's name and any other identifying information required. All women were then followed up till delivery. Women were categorized into two arms: women who delivered preterm (before 37 completed weeks of gestation) and women who delivered at term (after 37 completed weeks of gestation).

NCT ID: NCT03292939 Completed - Preterm Labor Clinical Trials

Progestrone and Doppler Indices

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

The aim of our study is to assess the effect of vaginal progestrone on fetal and maternal doppler indices

NCT ID: NCT03253016 Recruiting - Preterm Labor Clinical Trials

The Impact of Cervical Cerclage or Vaginal Progesterone on Vaginal Microbiome Distribution

Start date: March 26, 2017
Phase: N/A
Study type: Interventional

A comparative evaluation to evaluate the correlation between cervical cerclage or vaginal progesterone and maternal vaginal microbiome distribution during pregnancy

NCT ID: NCT03251885 Recruiting - Preterm Labor Clinical Trials

Extended-spectrum β-lactamase -Producing Enterobacteriaceae (ESBL) Vertical Transmission in Women With Preterm Labor Versus Those in Term Pregnancy

Start date: April 12, 2017
Phase:
Study type: Observational

The aims of the study are to evaluate the rate of ESBL-producing Enterobacteriaceae colonization among women in preterm labor and term labor, the incidence of maternal vertical transmission of ESBL, and the clinical significance of ESBL in preterm infants.

NCT ID: NCT03251794 Completed - Preterm Labor Clinical Trials

Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor

Start date: March 1, 2017
Phase:
Study type: Observational

Preterm birth continues to be a major public health problem with lasting family and societal repercussions. Despite tremendous research effort, prevention strategies have failed, and the prevalence of preterm birth in the United States reached 12.3% in 2003. Prematurity causes 70% of fetal/neonatal deaths. 11.4% of births are at < 37 weeks' gestation. The rate of prematurity increases dramatically with the number of fetuses - singletons 10%; twins 54.9%; and triplets 93.6%

NCT ID: NCT03210415 Enrolling by invitation - Preterm Labor Clinical Trials

Study on Prevention, Treatment and Mechanism of Preterm Labor for Chinese Pregnant Women ≥35 Years Old

Start date: August 1, 2017
Phase:
Study type: Observational

In China, there's no effective prevention and treatment on preterm birth for pregnant women ≥35 years old, so this study is necessary.

NCT ID: NCT03205020 Recruiting - Preterm Labor Clinical Trials

Maternal Serum Amyloid A Levels in Pregnancies Complicated With Preterm Labour.

Start date: July 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

The aim of the current study is to assess the accuracy of maternal serum amyloid A for prediction of preterm labor in women with threatened preterm labor.