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Pregnancy clinical trials

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NCT ID: NCT02848235 Completed - HIV Clinical Trials

Kenya Enhanced Mentor Mother ProgrAm (EMMA)

Start date: January 18, 2017
Phase: N/A
Study type: Interventional

Kenya recently adopted new treatment guidelines for pregnant women with HIV, which calls for all women to initiate triple-drug antiretroviral therapy (ART) at or soon after their first visit for antenatal care. As part of this new standard of care to prevent mother to child transmission of HIV (PMTCT), Kenya also established the Kenya Mentor Mother Program (KMMP) in 2012 to provide guidance for standardizing peer education and psychosocial support services within the national PMTCT program. This new standard of care (life-long ART and the KMMP) will only yield significant improvements in preventing mother to child transmission if women accept the triple-drug treatment during pregnancy and adhere to visit schedules so that they receive uninterrupted supplies of their medications during pregnancy through at least the cessation of breastfeeding. The primary objectives of this study are: (1) to evaluate implementation of the new guidelines in Kenya under actual, real-world conditions in major maternal and child health clinics in the southern Rift Valley region of Kenya; and (2) to evaluate, also under routine program conditions, the benefits of an innovative intervention package designed to improve implementation of the new treatment guidelines. The intervention uses the existing Mentor Mothers, who already are part of the PMTCT program staff at clinics. At the end of each clinic visit, the Mentor Mother will review with patients their treatment plan and schedule their next visit. The Mentor Mother will also offer, at each encounter, to send a text message reminder to the patient for their next clinic visit and offer to set up an automatic reminder directly on the patient's cell phone. The intervention strategy was developed in close collaboration with local health facility and PMTCT program staff based on their prior and on-going experience providing PMTCT services in the region, and this strategy has the potential to dramatically improve PMTCT service delivery and support global goals to eliminate mother to child transmission. The study is taking place in 12 clinics in the south-rift valley region of Kenya. A total of 360 patients will be enrolled into the study (approximately 30 at each clinic). The investigators are enrolling patients to receive their permission to look at information recorded in their medical records. All patients eligible for the study, who provide written consent, will be included in the study until the target number of 360 is obtained. After consenting, the study will have no further contact with patients. Because the study only reviews information in medical files that clinics already collect as part of routine care, risks to patients are minimal. The only possible risk is the accidental disclosure of HIV status, but the study is designed to minimize such a risk. There are no direct benefits to study participants, as the study is designed to understand existing adherence to PMTCT care and treatment and to improve such adherence. The study is expected to start in 2016 and end in 2019.

NCT ID: NCT02845284 Completed - Pregnancy Clinical Trials

'HI-4-TU' Study: Health Improvement for Teen Ugandans Study

Start date: March 30, 2016
Phase: N/A
Study type: Interventional

This randomized clinical trial is an adolescent focused implementation science study directed at improved social support and prevention of both HIV/STI's and subsequent unplanned pregnancies. The study population is pregnant adolescents who are attending antenatal care in Kampala, Uganda The acceptability and effectiveness of two enhanced peer lead, reproductive health promotion interventions compared to routine health care will be studied. The study participants will be individually randomized to one of three arms.

NCT ID: NCT02843984 Completed - Pregnancy Clinical Trials

Influence of Vaginal Lactoferrin on Amniotic Fluid Cytokines to Avoid Pregnancy Complications

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

Objective: To evaluate the influence of vaginal Lactoferrin administration on amniotic fluid concentration of 47 cytokines, chemokines and growth factors.

NCT ID: NCT02840019 Recruiting - Pregnancy Clinical Trials

Advanced Fetal Imaging - Phase II

Start date: July 2016
Phase: N/A
Study type: Interventional

The goal of Advanced Fetal Imaging - Phase II is to advance fetal MRI imaging by designing MRI coils specifically for pregnant women and testing recently developed MRI image acquisition techniques. The investigators aim to more reliably obtain higher quality fetal MRI images when compared to current clinical fetal MRI.

NCT ID: NCT02831556 Completed - Pregnancy Clinical Trials

Point of Care 3D Ultrasound for Various Applications: A Pilot Study

Start date: July 2016
Phase:
Study type: Observational

Summary 1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen and/or pelvis. 2. Study activities and population group. The study population will be a convenience sample of patients of any age presenting to the Emergency Department with complaints necessitating a clinical abdominal and/or pelvic imaging. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. 3.Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality. This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. The investigators are not measuring the effect of the ultrasound examination on the subjects' outcomes.

NCT ID: NCT02828852 Completed - Pregnancy Clinical Trials

Study of the Platelet Function During the Last Month of Pregnancy

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

The objective is to compare women's platelet answer in the last month of pregnancy to women old enough to procreate, no pregnancy and without hormonal treatment. The hypothesis of research is that the decrease of platelet answer in pregnant women could not only limit the occurence of embolic accidents but also explain the lowest incidence of the arterial thrombosis in comparison with the venous thrombosis.

NCT ID: NCT02818842 Recruiting - Pregnancy Clinical Trials

Evaluation of Drug's Risk in Pregnant Women

EFEMERIS
Start date: January 2010
Phase:
Study type: Observational

Medication during pregnancy can lead to the occurrence of birth defects or neonatal pathologies. Thalidomide or diethylstilbestrol (Distilbene°) are prominent examples. Many drugs remain insufficiently evaluated in this area and doctors are too often deprived of relevant information when prescribing drugs in pregnant women.

NCT ID: NCT02817464 Completed - Pregnancy Clinical Trials

Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle

Start date: October 26, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this pharmacodynamic and pharmacokinetic study is to identify a dose of TV-46046 (within the range 80 to 300 mg) that is both safe and consistent with contraceptive effect when injected every 6 months.

NCT ID: NCT02815501 Withdrawn - Pregnancy Clinical Trials

Thyroid Dysfunction and Obstetric Complications

TDOC
Start date: March 1, 2012
Phase:
Study type: Observational

Obstetric complications are common and can be responsible for maternal and foetal morbidity and mortality. Thyroid dysfunction has been identified as a possible cause of obstetric complications. Many studies have been conducted to estimate the prevalence and define the nature of obstetric complications observed in patients with thyroid dysfunction. However, women with obstetric complications are not systematically screened for thyroid dysfunction and no published study has evaluated the prevalence of thyroid dysfunction in women with an obstetric complication. As no consensus has been reached concerning systematic screening for thyroid dysfunction in pregnant women, the identification of new high-risk populations could possibly result in a change of clinical practice.

NCT ID: NCT02814344 Terminated - Pregnancy Clinical Trials

Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour

PropEHG
Start date: August 9, 2011
Phase:
Study type: Observational

The original aspect of the methodology proposed for this study concerns the use of as many as 16 electrodes to study the propagation and coordination (or synchronization) of uterine contraction. Over the last two years, the Compiègne University of Technology and the University of Reykjavik (Iceland) teams have developed the tools required to obtain good quality signals during electrohysterography and have worked on filtering and mapping of uterine electrical activity derived from these signals.