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Stillbirth clinical trials

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NCT ID: NCT01990625 Completed - Pregnancy Clinical Trials

A Cluster-Randomized Trial of Ultrasound Use to Improve Pregnancy Outcomes in Low Income Country Settings

Start date: April 2014
Phase: N/A
Study type: Interventional

In many low-income countries, the use of ultrasound by medical officers and non-physician health care staff (e.g., midwives) for antenatal identification of high risk pregnancies is a new intervention requiring authoritative investigation. The primary hypothesis to be assessed in this study is that antenatal ultrasound screenings performed by medical officers and non-physician health care staff will significantly reduce a composite outcome consisting of maternal mortality and maternal near miss, stillbirth and neonatal mortality in low-resource settings. Underpinning this hypothesis are two assumptions. The first assumption is that antenatal detection of complicated pregnancies will lead to appropriate referral at the right time for complicated pregnancies to comprehensive emergency obstetric and neonatal care (EmONC) facilities. The second assumption is that ultrasound's introduction will increase antenatal attendance leading to greater rates of institutional delivery. To assess these underlying assumptions beyond the composite end point, this study will investigate the health system impact of compact ultrasound. Secondary outcomes include antenatal attendance rates, institutional delivery rates at basic EmONC facilities, referral rates to comprehensive EmONC facilities, cesarean section rates (both planned and emergent) and an assessment of medical officers and non-physician health care provider ultrasound competence and training quality.

NCT ID: NCT01888380 Completed - Stillbirth Clinical Trials

The Paediatric Virtual Autopsy Trial

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

In light of declining autopsy rates around the world, post-mortem MR imaging is a promising alternative to conventional autopsy in the investigation of infant death. A major drawback of this non-invasive autopsy approach is the fact that histopathological and microbiological examination of the tissue is not possible. The objective of this prospective study is to compare the performance of minimally invasive, virtual autopsy, including CT-guided biopsy, with conventional autopsy procedures in a paediatric population. Foetuses, newborns, infants and children that are referred for autopsy at three different institutions associated with the University of Zurich will be eligible for recruitment. All bodies will be examined with a commercial CT and a 3 Tesla MRI scanner, and investigators will be blinded to the results of conventional autopsy. After cross-sectional imaging, CT-guided tissue sampling will be performed by a multifunctional robotic system (Virtobot) allowing for automated post-mortem biopsies. Virtual autopsy results will be classified with regards to the likely final diagnosis and major pathological findings and compared to the results of conventional autopsy, which remains the diagnostic gold standard. This interdisciplinary study will determine whether virtual autopsy will narrow the gap in information between non-invasive and traditional autopsy procedures.

NCT ID: NCT01867749 Completed - Clinical trials for Major Depressive Disorder

Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal Loss

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

The purpose of this study is to conduct a randomized pilot trial in a sample of 60 women who meet criteria for Major Depressive Disorder (MDD) 1-18 months after a perinatal loss to demonstrate the feasibility of the proposed recruitment methods and research design, of the therapist training methods, and of delivering the adapted Interpersonal Psychotherapy group treatment. The investigators would like to examine preliminary evidence for the following hypotheses: - Perinatal-loss specific IPT-G will be more acceptable to women who experience MDD following perinatal loss than will Coping with Depression (CWD). - Perinatal-loss specific IPT-G will result in reduced time to remission from MDD and reduced depressive symptoms relative to CWD. - Perinatal-loss specific IPT-G will result in increased social support and social functioning, reduced couple distress, and reduced grief relative to CWD.

NCT ID: NCT01777022 Completed - Pregnancy Clinical Trials

Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.

AFFIRM
Start date: January 1, 2014
Phase: N/A
Study type: Interventional

Rates of stillbirth in Scotland are among the highest in resource rich countries. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency being the commonest clinical finding. Maternal perception of decreased fetal movements appears to be an early biomarker both of placental insufficiency and subsequent stillbirth. The study proposed here will test the hypothesis that rates of stillbirth will be reduced by introduction of a package of care consisting of strategies for increasing pregnant women's awareness of the need for prompt reporting of decreased fetal movements, followed by a management plan for identification of placental insufficiency with timely delivery in confirmed cases. The odds of stillbirth fell by 30% after the introduction of a similar package of care in Norway but the efficacy of this intervention (and possible adverse effects and implications for service delivery) have not been tested in a randomized trial. The investigators plan a stepped wedge cluster design trial, in which hospitals in Scotland and Ireland will be randomized to the timing of introduction of the care package. Outcomes (including the primary outcome of stillbirth) will be derived from Scotland and Ireland's detailed routinely collected maternity data, allowing the investigators to robustly test the hypothesis. A nested qualitative study will examine the acceptability of the intervention to patients and health care providers and identify process issues (barriers to implementation).

NCT ID: NCT01699945 Completed - Neonatal Deaths Clinical Trials

Using Ongoing Newborn Intervention Trials to Obtain Additional Data Critical to Maternal, Fetal and Newborn Health in a Harmonized Way

AMANHI
Start date: August 2012
Phase: N/A
Study type: Observational

The goal of this study is to generate unique information to guide improvements on interventions to reduce maternal and newborn mortality as well as prevent stillbirths. The objective of this study is to determine the burden, timing, and causes of maternal deaths, stillbirths and neonatal deaths. This will be an observational study where data will be collected retrospectively in the context of the ongoing study in Haryana, India. Women of reproductive age living in the study area have already been enumerated for the parent studies. Active surveillance is being conducted for identifying pregnancies and deaths among women of reproductive age in the population through 3 monthly home visitations. Verbal autopsies will be conducted for all deaths of women in the reproductive age, including those who died in pregnancy, childbirth and up to 42-60 days after childbirth. Verbal autopsy interviews will also be conducted for all stillbirths.

NCT ID: NCT01664546 Not yet recruiting - Pregnancy Clinical Trials

Study of the Best Blastocyst Post Transfer by aCGH

Start date: September 2012
Phase: N/A
Study type: Observational

An Observational, blind and prospective study of Preimplantational Aneuploidy Screening by aCGH in Trophectoderm Biopsy

NCT ID: NCT00878098 Completed - HIV Infections Clinical Trials

Study of DDT and Loss of Clinically-Recognized Pregnancies in South Africa

Start date: June 1, 2009
Phase:
Study type: Observational

Background: - In some countries, such as South Africa, the pesticide DDT is an important chemical for control of malaria-carrying mosquitoes. However, there is little evidence about the effects that it might have on human health. - DDT has been associated with miscarriage and fetal loss in areas with high levels of exposure, but more research is needed to determine what levels of exposure are associated with loss of pregnancies. Objectives: - To examine the relationship between pre-pregnancy levels of DDT in the blood and the loss of clinically recognized pregnancies. - To conduct a pilot study to evaluate data collection procedures for future research. Eligibility: - Women between 20 and 30 years of age who are not currently pregnant and who reside in villages in the Vhembe District in the northeastern part of South Africa. Design: - Evaluation of eligibility: 1. Short physical examination, with questionnaire about medical history, current living conditions, and daily life. 2. Several blood samples will be taken for study and to test for anemia, elevated lead levels, malaria, syphilis, and human immunodeficiency virus (HIV). - Half of the women will come from villages that are currently being sprayed with DDT, and half will come from villages that are not being sprayed. - Evaluation before and during pregnancy for subjects who become pregnant: 1. Blood and urine test, including urine pregnancy test. 2. Questions about recent menstrual history and sexual activity. 3. Questions about medical history, including treatment for malaria. - Pregnancy follow-up study, including blood draws, will be conducted regardless of whether the pregnancy is carried to term. - Researchers will assess and adjust study parameters as needed.

NCT ID: NCT00270530 Completed - HIV Infections Clinical Trials

Intermittent Preventive Treatment of Malaria in HIV-Seropositive Pregnant Women in Zambia

Start date: November 2002
Phase: Phase 4
Study type: Interventional

Prevention of malaria in pregnancy is critical given the high incidence of malaria in Zambia and its serious impact on both maternal and infant survival. Intermittent presumptive treatment with sulfadoxine-pyrimethamine has been shown to be highly efficacious for reducing the risk of malaria in pregnancy. However, based on a study done in western Kenya, HIV-infected pregnant women may need more frequent dosing of SP, i.e., on a monthly basis rather than the standard 2-dose regimen given during the second and third trimesters, as HIV appears to reduce the effectiveness of the SP drug combination. The goal of this study was to evaluate the efficacy of the standard dosing regimen in comparison to an intensive monthly SP dosing schedule in HIV-positive women.

NCT ID: NCT00133744 Completed - Stillbirth Clinical Trials

Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality

Start date: May 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether a daily prenatal supplement of iron plus folic acid or a daily prenatal supplement with multiple vitamins and minerals given to women from their first prenatal visit through delivery reduces perinatal mortality compared with a daily prenatal supplement of folic acid alone.