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Obstetric Labor, Premature clinical trials

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NCT ID: NCT02021539 Terminated - Clinical trials for Obstetric Labor, Premature

The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery

ElastoMAP
Start date: February 2014
Phase: N/A
Study type: Observational

The hypothesis tested is that the physical changes associated with cervical ripening result in a detectable decrease in rigidity. The main objective of this study is therefore to determine whether the measured elastographic rigidity of cervical tissues in addition to cervix size can be used to predict delivery within the next 48 hours (creation of a prognostic score).

NCT ID: NCT01987024 Completed - Clinical trials for Patients With a Risk of Preterm Labour

Advantage of Detection of phIGFBP-1 to Reduce Hospitalization Time for Stable Patients With a Risk of Preterm Labour.

Start date: October 2013
Phase: N/A
Study type: Interventional

It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total duration of hospitalization for patients with a risk of preterm labor before 32 weeks of gestation without increasing the number of preterm labour. Methods Patient with a risk of preterm labor (ultrasound cervical length < 25 mm +/- described or recorded uterine contractions) before 32 weeks of gestation will be hospitalized to receive tocolytic drugs and antenatal corticosteroid therapy according to our gold standard protocol. After 48 hours, they will be assessed by examination, external tocodynamometry and the measure of cervical length by ultrasound. Stabilized patients will be included and randomized into 2 groups of 210 patients each. The first group "A" will benefit from the standard protocol (extended hospitalization of 2 or 4 days according to the clinical and ultrasound assessment); whereas the second group, "B", will have the benefit of the detection of phIGFBP-1.If the result proves negative, patients could be discharged early at day 2. In the case of a positive result, patients will follow the standard procedure because of the low positive predictive value of the test. The main outcome is the total duration of hospitalization. Study duration The trial period will be 36 months. Expected results The use of detection of IGFBP-1 would enable us to select patients at risk and to decrease the duration of hospitalization in the case of a negative result. Perspectives The negative predictive value of phIGFBP-1 test could be useful to select patients with stabilized risk of preterm labor, who could be discharged early. Moreover it could be used, in the Perinat Sud network, to decide if patients with a risk of preterm labor would benefit from hospitalization in a level II or III maternity ward.

NCT ID: NCT01985594 Not yet recruiting - Preterm Labor Clinical Trials

Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial

UTROGESTAN
Start date: November 2013
Phase: Phase 2
Study type: Interventional

RESEARCH HYPOTHESIS -Incidence of preterm delivery is lower in women treated with oral micronized progesterone (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side effect

NCT ID: NCT01975792 Completed - Clinical trials for Women Admitted to Labor and Delivery for the Management of Preterm Labor and/or Preterm Premature Rupture of Membranes (PPROM)

Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes

TIPS
Start date: March 2013
Phase: N/A
Study type: Observational

The thymus gland is a specialized organ in the chest that plays a central role in the adaptive immune system throughout development until puberty. In response to stress, the fetal thymus gland may shrink, or involute. The investigators propose a prospective cohort study that will enroll pregnant women admitted to labor and delivery for the management of preterm labor and/or preterm premature rupture of membranes from 28-36 weeks gestation. Based on sonographic thymus measurements, the investigators will develop a clinical prediction tool to identify babies who are at increased risk for adverse neonatal outcomes. A reliable non-invasive predictor of adverse neonatal outcome using thymic ultrasound measurements has the potential to affect clinical management, improve outcomes for premature babies, and direct further research efforts.

NCT ID: NCT01916330 Completed - Preterm Labor Clinical Trials

Development of Pharmacokinetics Model in Pregnancy Women and Fetus

Start date: January 14, 2013
Phase:
Study type: Observational

Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and fetus

NCT ID: NCT01912508 Recruiting - Preterm Labor Clinical Trials

Preterm Labor Prediction by Cervical Contour in Ultrasound

Start date: August 2013
Phase: N/A
Study type: Observational

Cervical length is a already known predictor for preterm labor. In this study the investigators want to examining the hypothesis that cervical curvature is also a predictor for preterm labor and that moderate transducer pressure influence cervical length. study population: 200 consecutive pregnant women between 14-34w, visiting in the ultrasound unit ether for routine screening or because of preterm labor. During their examination cervical length and curvature measurements will be taken. Another measurement will be taken after applying moderate cervical pressure. The investigators will compere cervical contour and pressure influence between groups and according to cervical length Demographic data will be taken at the time of recruitment and pregnancy outcome measures in a later telephone interview.

NCT ID: NCT01869361 Withdrawn - Preterm Labor Clinical Trials

Indomethacin for Tocolysis of Preterm Labor

Start date: August 1, 2020
Phase: Early Phase 1
Study type: Interventional

Indomethacin for tocolysis for 48 hours vs placebo

NCT ID: NCT01868308 Completed - Back Pain Clinical Trials

Screening To Obviate Preterm Birth

STOP
Start date: January 2013
Phase: N/A
Study type: Observational

Our objective is to investigate the predictive value of a panel of biomarkers associated with two biologically plausible pathways of preterm birth: membrane breakdown and cervical remodeling. The investigators will obtain cervical length, cervicovaginal fetal fibronectin, and a panel of novel cervicovaginal biomarkers associated with cervical remodeling in a prospective cohort of symptomatic women with a singleton pregnancy at high risk for preterm birth in an effort to better risk stratify this cohort.

NCT ID: NCT01867996 Completed - Clinical trials for Obstetric Labour, Premature

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ)

Start date: June 11, 2013
Phase: Phase 1
Study type: Interventional

This will be a randomized single sequence open label study. This study is designed to determine if chronic dosing with efavirenz (EFZ) will have an effect on the pharmacokinetics (PK) of intravenously-administered retosiban in healthy volunteers. The study consists of screening (28 days), treatment (1 dosing session) and follow-up (7 to 14 days) period, and the total duration of study participation for each subject will be approximately 8 weeks. During the treatment period, subjects will be admitted to the clinical research unit the day before dosing (Day 1) and will remain until completion of the last assessment on Day 20. All subjects will receive on Day 1, a 6 milligrams (mg) bolus of retosiban for 5 minutes (min), followed by a 6 mg/hour (hr) infusion for 12 hrs. On Day 2, a washout day will occur. On Days 3-17, subjects will receive EFZ 600 mg once daily in the evening. On Day 18, subjects will receive a 6 mg bolus of retosiban for 5 mins, followed by a 6 mg/hr infusion for 12 hrs plus a 600 mg dose of EFZ.

NCT ID: NCT01840228 Terminated - Premature Birth Clinical Trials

Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor

PAL
Start date: May 2013
Phase: N/A
Study type: Interventional

Preterm birth, defined as birth before 37 weeks' gestation, is a leading cause of infant death and disease. Progesterone is the single most effective intervention in the prevention of preterm birth. However, current use of this therapy is limited to certain high-risk groups including women with a history of preterm birth and women with a short cervix. This study seeks to evaluate the efficacy of this preventive therapy in another high-risk group: women with arrested preterm labor. The investigators hypothesize that administration of vaginal progesterone in women who present with preterm labor but remain undelivered 12 hours after cessation of short-term therapy to inhibit contractions will result in lower rates of preterm birth before 37 weeks' than will administration of placebo.