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Pregnancy clinical trials

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NCT ID: NCT01577316 Not yet recruiting - Pregnancy Clinical Trials

Evaluate the Immunogenicity and Safety of the 2011-2012 Vaccine Against Seasonal Influenza on Pregnant Women

VACINFL2011
Start date: April 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The hypothesis proposed in this study is that the 2011-2012 Seasonal Influenza Vaccine (including H3N2 and H1N1 subtypes of serotype A strain over the serotype B) administered to 15ug (without adjuvant) via intramuscular in pregnant women will be safe and immunogenic.

NCT ID: NCT01436448 Not yet recruiting - Pregnancy Clinical Trials

Probiotics (Lactobacillus Rhamnosus) in Reducing Glucose Intolerance During and After Pregnancy

GRIP
Start date: October 2011
Phase: Phase 3
Study type: Interventional

Introduction: The overall aim of the study is to assess the efficacy of Lactobacillus Rhamnosus in reducing glucose intolerance during and after pregnancy. A second objective of the study is to determine the feasibility, compliance and safety of Lactobacillus Rhamnosus among this cohort. Within this goal is to determine whether the investigators can enroll women at high risk for developing Gestational Diabetes Mellitus (GDM) and follow them out at regular antenatal visits and 6-weeks post partum. Women with GDM are, 7 times more at risk of developing type 2 diabetes compared with those who had a normo- glycaemic pregnancy. The population attributable risk for type 2 diabetes mellitus (DM) in women with GDM is high, and around 30 - 50% women with GDM converts into type 2 (DM) which is associated with pre-mature morbidity, mortality and high economic burden. It is evident that untreated GDM is associated with higher incidence of complications during pregnancy and increases the risk of perinatal mortality and infant morbidity. The prevalence of GDM in Pakistan is around 8%, comparatively higher than other South Asian countries. Therefore, interventions that can improve glucose regulation during pregnancy are highly important. Probiotics, the live micro-organisms, have shown promising results in regulating glucose metabolism among pregnant mice. The effect of Probiotics on glucose metabolism is attributable to their immuno-regulatory properties. They elicit powerful anti-inflammatory capabilities by inhibiting the NF-kB pathway, which mediates microbial activation of the immune system. Further, they diminish both fermentation of polysaccharides and induction of fasting-induced adipocyte factor gene transcription. The safety of Lactobacillus Rhamnosus among pregnant women is already established in other diseases. A placebo controlled trial from Finland on pregnant females randomized to receive either dietary counseling and Probiotics (Lactobacillus Rhamnosus), concluded improved glucose tolerance as compared to the placebo group [OR 0.31 (95% CI 0.12, 0.78)]. However, this study could not determine the sole effects of probiotics in reducing glucose intolerance. Nevertheless, no studies on the role of Lactobacillus Rhamnosus in regulating glucose intolerance have been conducted in any other part of the world yet. Therefore, a pilot trial to see the efficacy, compliance and feasibility of Lactobacillus Rhamnosus among pregnant females is imperative. The objectives of the investigators study are: - To assess the efficacy of Probiotics Lactobacillus Rhamnosus (1010 Colony forming Units (CFU)/day) in reducing glucose intolerance among pregnant women attending antenatal clinic of Karachi-Pakistan. - To assess the feasibility, compliance and safety of conducting a double blind, placebo controlled randomized trial of Lactobacillus Rhamnosus by recruiting high risk women during pregnancy attending antenatal clinics and following them up 6 weeks postpartum in Karachi-Pakistan. Methods: For the pilot trial, women will be recruited from antenatal hospital of the city, during 12-14 weeks of gestation. Study Design: The study will be double blind randomized, placebo controlled trial. Randomization will be done by blocked method. The dose of 1010 Colony forming Units (CFU) once daily till delivery will be given orally. Study Endpoints and Ascertainment: Baseline information will be comprised of socioeconomic status, parity, gravida, blood pressure and obstetric history etc. The study endpoint comprises of efficacy, feasibility, compliance and safety and will be ascertained at monthly follow-up, during week 24 - 28, and 6 weeks post partum. Efficacy will be ascertained by Oral Glucose Tolerance Test (OGTT) performed at randomization and during 24-28 weeks of gestation. Feasibility and compliance will be assessed through recruitment rate, drop-out rate, reasons for drop-out, non-participation and empty drug sachet count.

NCT ID: NCT01252706 Not yet recruiting - Pregnancy Clinical Trials

Estimation of Alcohol, Substance and Cigarettes Exposure Among Pregnant Women in the Israeli Periphery and Center, and the Contribution of Brief Intervention

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

The aims is to evaluate the rate of exposure to alcohol, psychoactive substance and nicotine among pregnant women in periphery hospital (Poria) and in the center of Tel Aviv (Ichilov) and to evaluate study Brief Intervention impact on reduction exposure, and its effect on newborn outcomes.

NCT ID: NCT01192646 Not yet recruiting - Pregnancy Clinical Trials

Home Based Life Saving Skills Training in a Rural Area in Tanzania

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

Background The maternal mortality ratio in Tanzania has been persistently high for ten years with no signs of the ratio going down.The Tanzania Demographic and Health Survey (TDHS) of 1999 and 2005 estimate the maternal mortality ratio to be 528 and 578 per 100,000 live births respectively (TDHS 1999, TDHS 2004/05).The major direct causes include obstetric haemorrhage, obstructed labour, pregnancy induced hypertension, sepsis and abortion complications. Most deliveries (53%) in Tanzania occur outside the health facilities. Of these 53% of births that occur outside the health facilities 31% are attended by relatives, 19% by traditional births attendants (TBA) while 3% have no assistance at all. Though, the proportional of mothers delivering in health facilities (47%) and receiving skilled attendance at birth (46%) is low but more than 94 percent of women attend antenatal care (ANC) in health facilities at least once. This indicates that there are factors that impede these women delivering in the health facilities. Low awareness of obstetric danger signs may be one of the contributing factors for delay to decide to seek care when a complication occur thus contributing the first phase of delay. Studies in Tanzania show that most women are not aware of danger signs of obstetric complications during pregnancy, delivery and after delivery. A study conducted in Mtwara rural to assess the use and determinants of skilled attendants at delivery showed that proportional of women delivered with skilled care increases with increasing knowledge of pregnancy danger signs, but it also showed that few women have knowledge of pregnancy danger signs An increasing body of evidence supports the importance of community participation in maternal and infant health programs for establishing ownership, identifying problems effectively, achieving equity and helping to institutionalize health programs. To mount an effective maternal health effort aimed at reducing maternal and infant mortality, multiple levels of program and policies need to be in place and functioning. In addition, linkages, from the communities, local dispensaries and health centres to first referral hospitals that are adequately equipped, need to be developed and sustained A home based life saving skills (HBLSS) is a strategy that intends to educate pregnant women and their primary family caregivers and home birth attendants on critical knowledge and skills to keep a pregnant woman healthy, to recognize life-threatening maternal and newborn complications and promote the adoption of health care and health-seeking behaviours at the individual and community levels. The aim of this strategy is to prevent maternal and neonatal morbidity and mortality through creating awareness on women's birth preparedness and access to emergency obstetric care services RESEARCH QUESTIONS 1. Can HBLSS increase women empowerment and male involvement in the decisions relating to access of emergency obstetric and newborn cares? 2. Can the HBLSS increase hospital deliveries, increase awareness of obstetric and neonatal danger signs, birth preparedness and emergency readiness in a rural community? Objectives Broad Objectives: 1. To investigate social-cultural, community and traditional practices that impact on women's birth preparedness and access and utilization of emergency obstetric care services in rural district. 2. To assess the impact of home based life saving skills (HBLSS) on hospital delivery awareness of obstetric and neonatal danger signs, birth preparedness Specific Objectives 1. To explore customs, taboos and practices including herbal remedies during pregnancy and labour that influence birth preparedness and utilization of emergency obstetric care services. 2. To assess perception, attitude and health seeking behaviour when a complication occur. 3. To determine the effect of HBLSS educational programme on hospital delivery, birth preparedness, emergency readiness and utilization of emergency obstetric care services among women in Rufiji district. 4. To assess the impact of HBLSS educational programme on male awareness and involvement in assisting women on birth preparedness and access to emergency obstetric care services. 5. To determine the cost-effectiveness of HBLSS educational programme Methodology A Cluster Randomized Trial 28 clusters will be randomly selected, 14 clusters will receive HBLSS training and the other 14 clusters will not receive HBLSS training.

NCT ID: NCT01093144 Not yet recruiting - Pregnancy Clinical Trials

Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements

Start date: April 2010
Phase: N/A
Study type: Interventional

Assessing the relation between the Pelvis diameters measured by the LaborPro, and the mode of delivery(normal vaginal delivery/instrumental delivery/Caesarean section.

NCT ID: NCT01074112 Not yet recruiting - Pregnancy Clinical Trials

Keller Prehospital Ultrasound Study

Start date: March 2010
Phase: N/A
Study type: Observational

The study is based on the premise that ultrasound is not commonly used in an ambulance. There are some departments that do deploy it into the field, but of those departments there is almost no data collected about its use. Currently Paramedics are not recognized by insurance companies as health care providers capable of performing ultrasound. If there were more data on the subject that may eventually change. We are hoping to prove that not only is ultrasound useful in an ambulance, but that paramedics are good at interpreting the results. We will save images, the paramedic's diagnosis and some basic information about the call. We will not save any protected health information (PHI) or any information linking the subject to the study. The data collected will be sent to a non-biased ultrasound reviewer to grade the images for the accuracy of diagnosis and the quality of the view obtained. This data will be used to formulate a report and statistics on paramedic's ability to perform ultrasound in the field.

NCT ID: NCT01042483 Not yet recruiting - Pregnancy Clinical Trials

Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based+Continuous Vacuum Mode

Start date: January 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to establish normograms of parameters measured by the LaborPro system, and to test the prediction of these parameters on labor progress and mode of delivery.

NCT ID: NCT00961987 Not yet recruiting - Pregnancy Clinical Trials

Innovation to Providing Interprofessional Maternity Care

Start date: October 2009
Phase: N/A
Study type: Interventional

The aim of this pilot project is to determine if there are differences in patient outcomes and healthcare utilization between patients randomly assigned to usual care (a collaborative model of maternity care with co-located healthcare professionals but with referrals to off-site obstetricians) or to a collaborative model of maternity care with co-located healthcare professionals, including obstetricians. It is hypothesized that by creating a seamless interface between obstetrical consultation and ongoing longitudinal maternity care, patient outcomes (birth outcome data), patient satisfaction and healthcare utilization, including number of outpatient visits, ultrasounds, laboratory tests, consultations, etc, will be improved in the intervention group compared with the group receiving usual care. The results could potentially lead to other sites adopting this innovative model of maternity healthcare delivery.

NCT ID: NCT00909376 Not yet recruiting - Pregnancy Clinical Trials

Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?

Start date: July 2009
Phase: N/A
Study type: Observational

Many pregnant women have an ultrasound done of their fetus in the beginning of the second trimester of pregnancy. Some have a transvaginal sonography while others have a transabdominal one, depending on clinical parameters such as weight, scars etc. In the transvaginal ultrasound there is some amount of version of the fetus done by the examiner to maintain a better aspect of the fetus, while this is not done in a transabdominal sonography. The objective of this trail is to determine whether having a transvaginal ultrasound as opposed to a transabdominal one has an association to adverse perinatal outcomes.

NCT ID: NCT00725660 Not yet recruiting - Pregnancy Clinical Trials

Pre-Eclampsia Prediction By Doppler Screening Of Uterine Arteries And Angiogenic Factors In Second Trimester Of Pregnancy

Start date: September 2008
Phase: N/A
Study type: Observational

BACKGROUND: Pre-eclampsia complicates about 2% of pregnancies. It accounts for at least 50 000 maternal deaths per year worldwide and is the second most common cause of maternal death in the developing world. Also, Pre-eclampsia is the commonest cause of iatrogenic prematurity, It frequently coexists with intrauterine growth restriction (IUGR) and placental abruption, other important causes of adverse prenatal outcome. There have been many studies investigating whether the disease can be prevented. In order to achieve this, one needs to be able to identify firstly those women that are at highest risk of the disease. Early studies showed that impedance to flow in the uterine arteries decreases with gestation in normal pregnancies, while in pregnancies with established pre-eclampsia or IUGR the impedance is increased. These observations led to a number of screening studies in the second trimester, which assessed if it is possible to predict those pregnancies destined to have complications of impaired placentation. These studies showed that women with increased impedance to uterine artery blood flow have an increased risk of developing pre-eclampsia, and detection can be further increased by using angiogenic factors (That are involved in the pathogenesis of Pre- eclampsia and could be useful for early prediction of the disease: VEGF, PIGF, PP13, sFLT1) in combination with uterine arteries Doppler study in the second trimester. METHODS: In this study we would like to add uterine arteries Doppler to the early routine detailed ultrasound examination (14-16 weeks), in 3000 women in Jerusalem. in addition we would like to check angiogenic factors from the serum blood taken for the routine triple test in these women (16-18 weeks).pregnancy outcome would be collected after labour from the medical centers participating in this research.