View clinical trials related to Obstetric Labor, Premature.
Filter by:Subclinical urogenital infections have been implicated in up to 70% of adverse pregnancy outcome, especially preterm labor and delivery. The most prevalent microorganisms involved in intrauterine infections are urogenital Mycoplasmas. Diagnosis by culturing or PCR merely detect the presence of the bacteria, pointing to colonized carriers only. There is no efficient and reliable diagnostic test to identify those subjects that have developed an infectious disease and are at risk of developing adverse pregnancy outcome. In order to identify women at risk for developing pregnancy complications, Promyco Diagnostics has developed a proprietary, simple and non-invasive serology diagnostic kit for the detection of urogenital Mycoplasma infection.
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.
The purpose of this study is to compare how well vaginal progesterone works delaying the time to delivery in women with preterm labor compared to placebo. The study will also compare the effect of vaginal progesterone on neonatal outcomes, rate of spontaneous preterm delivery, cervical length and biomarkers of preterm delivery in women diagnosed with and treated with medication to stop preterm labor.
Preterm birth (PTB) is a leading contributor to perinatal morbidity and mortality. While patients with preterm labor (PTL) are at an increased risk for PTB, not all PTL patients will deliver preterm. In patients with PTB, there is a high prevalence of 'intrauterine inflammation' as demonstrated by a large body of evidence. The presence of inflammation is noted by infiltration of inflammatory cells in the placenta and/or maternal fever in labor and/or elevation of cytokines in the amniotic fluid. Despite this significant association of inflammation with PTB, identification of women destined to deliver preterm by inflammatory markers in maternal blood has not been successful. To date, it has been difficult to determine which patients with PTL will experience PTB. Identification of biomarkers, such as high sensitivity C-Reactive Protein (hsCRP) as well as others such as sICAM, Pentraxin, sE-Selectin, and CxCL-10 in maternal serum and in placental cord blood, may help to serve three very important clinical aims. 1) Identification of novel biomarkers in maternal serum could help to distinguish those women with PTL who are most likely to deliver PTB. 2) These biomarkers may have a high negative predictive value and thus identify those women who are not likely to deliver preterm, avoiding undue hospital admission and medical therapies. 3) Select biomarkers in the mother and/or in cord blood may serve to identify those preterm neonates at greatest risk for adverse outcome. Through improved identification of these infants, studies with targeted therapies to reduce adverse neonatal outcomes in preterm neonates become feasible. This study involves a cohort assessment of women at risk for Preterm birth secondary to preterm labor, preterm premature rupture of membranes (PPROM), and cervical insufficiency (CI), between 22-0/7 and 33-6/7 weeks gestational age. We will obtain information regarding patients' pertinent past medical and obstetric history as well as small samples of maternal blood at up to four occasions, small samples of placental cord blood, a maternal saliva sample, and an infant buccal swab. We will follow each of these patient's pregnancy outcomes, and determine if there are any correlations between levels of certain biomarkers and latency to delivery as well as composite adverse neonatal outcomes. In women with PTB < 37 weeks, cord blood will be collected (as well as maternal saliva and an infant buccal swab) and biomarkers compared between those infants with and without specific adverse neonatal outcomes. Maternal saliva and buccal will be collected on all women and infants enrolled.
The aim of the present study is to establish, using polysomnographic criteria and prospective nature, whether sleep apnea in pregnancy is more prevalent in women with high risk pregnancies including preeclampsia, gestational diabetes, and pre-mature contractions, and to determine the effect of sleep disordered breathing in pregnancy on fetal outcome. The investigators' hypothesis is that sleep-disordered breathing is more prevalent in women with high risk pregnancy compared to those with uncomplicated pregnancy.
The aim of the pilot trial is to assess at what extend women with arrested threatened preterm labor change their activity patterns at home in response to bed rest prescription. An area of concern for the design of a trial is the strength of health provider's recommendation to change women's behaviors, and their compliance with bed rest recommendations. The study was a randomized parallel design. The intervention group consisted of total bed rest for four days (with allowance to go to the toilet). The control group consisted in the restriction of activities during four days.
The purpose of this study is to better understand (1) if phospholipase A2 producing microorganisms and cytokines (IL-1, IL-4, IL-6, IL-10, and IL-13) are associated with premature labor (2) if pregnant teens are more likely to have phospholipase A2 producing bacteria than a pregnant adults and (3) if there is a difference in the cytokines between pregnant teens and adults.We hypothesize that phospholipase producing microorganisms may trigger the onset of premature labor. The following are hypothesized: (a) The microorganism cultured should show high activities of phospholipase A2 (b) The cervical length measurement predictive value should correspond to the gestation age at term (c) Vaginal flora of teen will be more susceptible to colonization with higher phospholipase A2 producing bacteria than that of an adult (d) The maternal genotype contribution to the concentration of IL-1, IL-4, IL-6, IL-10, IL-13, and TNF-alpha during the first trimester of pregnancy in teens is different in the production of inflammatory cytokines and modulators(e) The maternal genotype of teens therefore influences the production of phospholipase A2 and causes an increase in preterm delivery.
Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11% of all pregnancies and it is responsible for 70% of sick babies. The ideal way to stop preterm labor when it occurs (which drug to use) is not known. Currently magnesium sulfate is used by about 95% of all practitioners, but recent data suggest magnesium given this way may be harmful for the baby's future development. Other drugs such as antiprostaglandin agents are very effective in stopping uterine activity, but particularly when used for >48 hours have been associated with both maternal and fetal sides effects. Lastly, calcium channel antagonists are effective in stopping contractions and have very little in the way of maternal and fetal side effects, but less data is available in the United States on their use. Because there is no FDA approved drug to stop preterm labor, we purpose to randomize all women with preterm labor (20-34 weeks) to receive one of the above three methods of stopping preterm labor. The primary outcomes will be to see which agent stops the uterine contractions most effectively, for the longest period of time with fewest relapses and results in significant prolongation of pregnancy. If one of these agents is clearly superior to the other two it would help women avoid early delivery or have significant extension of their pregnancy to avoid some of the complications of preterm birth in the baby.
The purpose of this study is to collect clinical specimens and corresponding clinical data to develop a non-invasive test for detection of intra-amniotic infection and prediction of preterm birth in women and intact amniotic membranes. The specimens collected will be used to develop a specific biomarker panel and algorithm using immunoassays for optimal detection of intra-amniotic infection in women with preterm labor and intact amniotic membranes.
Eligible patients will be informed and asked to enroll in the study at hospital admission. A transvaginal ultrasound examination will be performed to determine cervical length. If an eligible woman accepts to participate, patient will be randomized to one of the study arms assigned in a double blind basis. Patient will receive the medication (vaginal capsule of progesterone or placebo). The patient will administer herself one vaginal capsule in a daily basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate that the use of a maintenance treatment with vaginal progesterone is able to reduce the incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal and neonatal data will be collected.