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Obstetric Labor, Premature clinical trials

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NCT ID: NCT01429545 Completed - Preterm Labour Clinical Trials

Single Versus Combination Therapy in Acute Tocolysis

Start date: April 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the tocolytic efficacy, effectiveness and safety of Atosiban in comparison with the combination of Atosiban and Nifedipine together.

NCT ID: NCT01406197 Withdrawn - Preterm Labor Clinical Trials

Uterine Electrical Activity Before and After Progesterone Treatment for Preterm Labor

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

This study will examine the effects of various formulations of progesterone on uterine electromyographic (EMG) activity in pregnant patients in premature labor to determine if progesterone will suppress uterine electrical activity and which formulation may be best for inhibition of uterine activity. Patients will be monitored prior to treatment and following treatment (every 2 to 4 hours) with one of three different formulations of progesterone for up to two days. Patients will continue to be observed until they deliver. Comparisons will be for uterine EMG activity from before treatment to that following treatments at 2, 4, 8, 12 24 and 48 hours and times of delivery after treatments (hours or days following treatments). Comparisons between mean values for EMG activity between the various treatments at the various times will also be made.

NCT ID: NCT01375439 Completed - Pregnancy Clinical Trials

Maternal and Perinatal Outcome in Women With History of Premature Labor in Previous Pregnancy

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

Introduction: Preterm labor (PTL) is an important obstetric intercurrence that affects 5 to 10% of pregnancies. Among the known factors of PTL etiology are PTL occurrence in previous pregnancies, multiple pregnancies, polyhydramnios, vaginal bleeding during pregnancy, premature membrane rupture (PMR) and bacterial vaginosis. Despite the advancement achieved in Neonatology, morbidity and mortality resulting from high rates of preterm births have remained constant in the last few decades. Objective: This study aims at evaluating maternal and perinatal outcomes of pregnant women with a history of preterm labor in previous pregnancies and submitted to active search for vaginal infection. Material and Method: It is a prospective-cohort epidemiological study to be conducted in Botucatu/SP. Two study groups (G1 and G2) will be formed, and each of them will comprise 140 pregnant women with a history of preterm childbirth. G1 will be related to the active search and etiological diagnosis of lower genital tract infections, and G2 will be related to non-search for such infections, for which the routine care protocol of primary health units in the city of Botucatu will be maintained. Care propedeutics for the pregnant women (G1) will include the performance of direct examination of vaginal content stained by the Gram method, culture in Diamonds medium, polymerase chain reaction (PCR) of endocervical secretion collected in the primary health care services in the city at two moments: prior to the 20th gestational week (M1) and at the 36th week (M2). Moment M3 will take place after childbirth for evaluation of the perinatal outcome.

NCT ID: NCT01360905 Terminated - Multiple Pregnancy Clinical Trials

Study to Support Fetal Heart Rate and Uterine Contraction for Preterm Labor in Singleton and Multiple Pregnancies

Start date: May 2011
Phase: N/A
Study type: Observational

The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and pre term labor.

NCT ID: NCT01360034 Not yet recruiting - Clinical trials for Obstetric Labor, Premature

Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

Start date: December 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin as tocolytic for the treatment of preterm labour with short cervix (< 2.5cms).

NCT ID: NCT01340352 Completed - Preterm Birth Clinical Trials

Is It Possible to Predict Pre Term Labor by Measuring Cervical Length in the Non-pregnant Uterus?

Start date: May 2011
Phase: N/A
Study type: Observational

Working hypothesis and aims: To investigate the association between cervical length in non-pregnant women, and the risk of premature birth. The participants will be recruited from the HaEmek Medical Center delivery room registration. Women delivered between 24-37 pregnancy weeks will be allocated to the study group. The investigators will invite them 3 month or more after delivery to ultrasound examination of the cervical length. The participants in the control group will be the women whom term delivery follows by chronological manner to those in study group. Data of the cervucal length will be collected at the time of the examination.

NCT ID: NCT01340222 Completed - Preterm Labour Clinical Trials

Monocyte Chemotactic Protein-1 (MCP-1) Expressing Monocytes to Predict Preterm Delivery: PhenoMAP Study

PHENOMAP
Start date: March 2011
Phase: N/A
Study type: Interventional

The threat of preterm labour (PTL) is the first cause of hospitalization in the course of pregnancy. Its diagnostic is based on clinical examination with a positive predictive value of about 40 %. The role of the Monocyte chemotactic protein-1 (MCP-1) in delivery has been suggested by its secretion in the amniotic fluid during labour and by the increase in the expression of its RNA messengers in the peripheral maternal blood. We have also shown that the proportion of MCP-1-expressing monocytes is higher in women with vaginal delivery compared with those with caesarean delivery prior the onset of labour. OBJECTIVES : Primary To seek link between the respective proportions of circulating maternal monocyte and lymphocyte subpopulations and the true onset of PTL characterised by delivery occurring within 7 days post admission. Secondary: to (1) compare the predictive values of these new markers with those currently used, e.g. quantification of fœtal fibronectin and assessment of cervical length and effacement, (2) Compare the respective proportions of monocytes and lymphocyte subpopulations in maternal blood and fœtal membranes, (3) determine if a correlation exists between the activation markers expressed by maternal monocyte and lymphocyte subpopulations and the neonatal outcomes of preterm infants. MATERIAL AND METHODS: 200 patients with a singleton pregnancy between 24 and 34 weeks of amenorrhea and complicated PTL, will be prospectively included in the maternity wards of Galway (Ireland) and of Dijon with the support of the perinatal network of Burgundy. A 2X5ml blood sample will be collected upon admission, at D1, D2, D4 and D6 for women who did not deliver within the first 7 days; finally, another blood sample will be drawn upon discharge. After delivery, foetal membranes will be collected to characterize and compare the various monocyte and lymphocyte subpopulations in the maternal blood. The characterization and the study of the level of activation of blood and foetal membrane cells will be performed using flow cytometry technique with suitable markers. The main judgment criteria will be the percentage of monocytes positively expressing MCP-1 for all three monocyte subpopulations ("inflammatory", "residents or patrollers" and "intermediates", according to CD14, CD16, CCR2 and MCP-1 markers. Lymphocyte subpopulations will be assessed using the following markers: CD45, CD3, CD4, CD8 (T lymphocytes), HLA-DR (activated T lymphocytes), CD19 (B lymphocytes), CD16/CD56 (NK Cells), intracellular IFN-gamma (Th1 lymphocytes), intracellular IL-4 (Th-2 lymphocytes), intracellular IL-17 and CCR6 (Th17 lymphocytes), CD4, CD25, Foxp3 and CD127 (Tregs). Univariate statistical analysis of quantitative data will be performed using the Mann and Witney test or ANOVA, after verification of the conditions of application. The comparisons of percentages will be done using Chi-square Pearson tests and the Fisher's exact test, as appropriate. The multivariate analysis will be performed using a stepwise descending analysis. TRANSLATIONAL DIMENSION: The characterization of the various monocyte and lymphocyte subpopulations in the maternal blood and in the foetal membranes might constitute an " immunological signature " of the labour and therefore validate the relevance of a predictive marker for clinicians. EXPECTED RESULTS AND PERSPECTIVES: The study of the various monocyte and lymphocyte subpopulations in the maternal blood will allow to better characterise the immunological mechanisms occurring at the start of premature labour and to identity predictive markers of the preterm delivery, to validate prospectively in order to optimize the management of PTL

NCT ID: NCT01317225 Recruiting - Preterm Birth Clinical Trials

Prevention of Preterm Labor in Patients With a Previous Episode of Threatened Preterm Labor With Progesterone

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy.

NCT ID: NCT01314859 Withdrawn - Clinical trials for Threatened Preterm Labor

Nifedipine Treatment in Preterm Labor

Start date: July 2011
Phase: Phase 3
Study type: Interventional

This is a study for pregnant women who have been diagnosed with Threatened Preterm Labor. The principal aim of this study is to compare the efficacy and safety of Nifedipine treatment versus Atosiban treatment over these patients' newborn babies.

NCT ID: NCT01286246 Terminated - Clinical trials for Obstetric Labor, Premature

Randomized Controlled Trial of Vaginal Progesterone in Women With Threatened Preterm Labor

PROTO
Start date: January 2011
Phase: Phase 4
Study type: Interventional

Prematurity remains the most important single factor in perinatal morbidity and mortality. Unfortunately, the rate of premature delivery is increasing in Canada and is especially high in Alberta with 7.5% of pregnancies ending before 37 weeks gestation. Despite years of research into the causes of spontaneous preterm labor, few effective treatments have been identified. Progesterone is one candidate treatment. The purpose of this study is to investigate whether progesterone can prolong pregnancy in women who have symptoms of preterm labor. Pregnant women who have symptoms of premature labor will be invited to take part in the study if they are between 22 to 24 weeks pregnant. If they agree to join the study, they will be randomly allocated to either take progesterone 200mg each day via the vagina until 36 weeks, or to take a placebo preparation. Neither the women nor their clinician will know which group they are in. Women and their babies will be followed until 28 days after the birth, to find out about the length of the pregnancy, any adverse events that might occur (none have been reported in previous trials), and to look at whether women have taken the treatment. When the study is complete, the results for the progesterone group will be compared to the placebo group. If progesterone is found to be useful in helping to prolong pregnancy, then this will be a possible treatment to help mothers in the future.