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Preterm Delivery clinical trials

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NCT ID: NCT01431885 Completed - Preterm Labor Clinical Trials

Two Methods of Diagnosing Preterm Labor

Start date: August 2011
Phase: N/A
Study type: Interventional

Use of modern diagnostic tools e.g. fetal fibronectin and ultrasound measurement of cervical length to diagnose preterm labor can result in improved outcomes compared to traditional diagnosis based on digital examination to measure cervical change.

NCT ID: NCT01353807 Completed - Metabolic Syndrome Clinical Trials

Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health

Start date: November 1989
Phase: N/A
Study type: Interventional

The aim of the trial is to investigate the effect of daily supplementation with 2.7 grams of long chain n-3 fatty acids during the third trimester of pregnancy. In 1990, 533 pregnant women, while they were in gestational week 30, were randomized to fish oil supplements providing the mentioned amount of long chain n-3 fatty acids, olive oil supplements, or no supplements; they were asked to take the supplements until delivery. Health outcomes were assessed during pregnancy and delivery. Further, offspring health and development has been examined during the ensuring two decades by making linkages to the rich Danish health and administrative registries, by asking the offspring to complete web-based questionnaires, and by examining the offspring physically.

NCT ID: NCT01178788 Completed - Preterm Delivery Clinical Trials

Progestagens for the Tertiary Prophylaxis of Preterm Delivery

PROTECT
Start date: February 2010
Phase: Phase 3
Study type: Interventional

Objective: This trial would evaluate the clinical effectiveness of Progesterone(P) and 17-hydroxy Progesterone (17P) in reducing PTD, in symptomatic women at risk because of cervical shortening, in the present pregnancy. Main outcome: Delivery before 37 weeks. Secondary outcomes: Gestational age at delivery, Delivery <32, <35 wks, hospital admissions before delivery, birth-weight centile, NICU admission, days of NICU admission, days of oxygen supply, composite neonatal complications, congenital neonatal malformations and anomalies. Allocated treatments will be: Group A: 17P 341 mg i.m./weekly (Lentogest, AMSA, Italy); Group B: micronized P 200 mg per vagina /day (Utrogestan, Besins Healthcare, Belgium) Group C: no treatment, clinical observation Concomitant treatments: Iron and folic acid supplementation, and Betamethasone (12 mg repeated once 24 hours apart) will be permitted. Is not allowed the treatment with tocolytics per os. Any treatment will be recorded. Duration: The period of enrollment is 15 months. Cases not randomized by a clinical unit will be competitively assigned later. Results are expected 20-24 months from starting. Sample Size: hypothesizing a risk of PTD = 0.30 efficacy is defined as a reduction to 50% (risk = 0.15). With a test potency = 0.80 and alpha = 0.025 study needs to enrol 160 patients/arm, with a total of 480 patients. Data analysis: Methodological Unit will assign randomized treatment through a web site and it will collect data through the same way.

NCT ID: NCT01119963 Completed - Preterm Delivery Clinical Trials

Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)

17PinPROM
Start date: October 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will: 1. increase the probability of continuing the pregnancy until a favorable gestational age. 2. increase the interval between randomization and delivery. 3. decrease neonatal morbidity.

NCT ID: NCT01031017 Completed - Preterm Delivery Clinical Trials

Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies

Start date: June 2007
Phase: Phase 4
Study type: Interventional

Twin pregnancies are at substantial increased risk of preterm delivery. Prophylactic administration of progesterone in singleton pregnancies at risk of preterm delivery has been shown to be effective in reducing the rate of such complication. The aim of this study is to investigate the effect of prophylactic administration of natural progesterone in twin pregnancies on the rate of preterm births.

NCT ID: NCT00883324 Completed - Preterm Delivery Clinical Trials

Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum

SpecOp
Start date: March 2009
Phase: N/A
Study type: Observational

Observational study to determine whether the proposed method of fFN specimen collection without a speculum is substantially equivalent to the approved method with a speculum examination when obtained at the gestational age of ≥ 24 weeks and ≤ 34, 6 days in symptomatic women and at the gestational age of ≥ 22 weeks, 0 days and ≤ 30, 6 days in asymptomatic women. A finding of substantial equivalency would support a modification to the labeling to allow the collection of specimens for fFN determination with or without a speculum examination.

NCT ID: NCT00799500 Completed - Pregnancy Clinical Trials

Bacterial Vaginosis in Pregnancy: Detection by Weekly Vaginal pH Testing

Start date: January 2007
Phase: N/A
Study type: Interventional

Interventional study to assess the effect of early detection and treatment of bacterial vaginosis in pregnancy on preterm delivery rate.

NCT ID: NCT00615550 Completed - Preterm Delivery Clinical Trials

PREGNANT Short Cervix Trial

Start date: March 2008
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to evaluate the usefulness of progesterone vaginal gel in decreasing the preterm birth rate in a population of pregnant women with short cervical length and at high risk for preterm birth.

NCT ID: NCT00468663 Completed - Preeclampsia Clinical Trials

Ambient Air Pollution, Preeclampsia, and Preterm Delivery

Start date: July 2006
Phase: N/A
Study type: Observational

An epidemiologic study of pregnant women in western Washington to measure the relationships between exposure to air pollutants and risks of preeclampsia and preterm delivery.

NCT ID: NCT00457886 Completed - Preterm Delivery Clinical Trials

Measurement of Hormone Levels in Patients Receiving 17-HPC for Preterm Delivery

Start date: July 2005
Phase: N/A
Study type: Observational

The purpose of this study is to measure hormones in the blood known to affect the timing of delivery after a single injection of 17-P in order to help understand its mechanism of action in preventing preterm delivery.