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Pregnancy clinical trials

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NCT ID: NCT02103361 Recruiting - Pregnancy Clinical Trials

Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

Start date: November 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

NCT ID: NCT02102282 Recruiting - Breast Cancer Clinical Trials

Breast Cancer During Pregnancy

BRCAPRE
Start date: October 2012
Phase: N/A
Study type: Observational

Patients are managed clinically according to ad hoc standards and scientific knowledge by a multidisciplinary team. Clinical decisions are made after a patient physician discussion. Blood and tissue samples are collected. Diagnostic, obstetric management surgical treatment, systemic treatment, perinatal results and follow up data are collected.

NCT ID: NCT02084680 Recruiting - Pregnancy Clinical Trials

Intervention Trial to Measure the Effect of Individual Prenatal Information Combined With Mobile Phones

Start date: June 2013
Phase: N/A
Study type: Interventional

Introduction There is compelling evidence for scheduled home visits to improve newborn health. There is also a growing wealth of evidence to support the use of mobile phones as a public health tool in low and middle-income countries. UNICEF and WHO have recommended implementation of home visits for newborn care improvement. In sub Saharan Africa the evidence for a combined scheduled home visit and mobile phone technology to improve neonatal health is lacking. In this study the investigators aim to determine the effect of scheduled home visits by Community Health Workers (hereafter referred to as Village Health Teams-VHTs) combined with mobile phone consultations on newborn care in Masindi, Uganda. Methods This is a community intervention trial to be conducted in Masindi and Kiryandongo in Uganda from May 2013 to June 2014. A mixed method data collection technique will be used. Our overarching hypothesis is that survival of the newborn requires a continuum of care from pregnancy to the newborn period. Eight health centres each will be randomly allocated to the intervention arm and a control arm. Five villages will be randomly selected from each of the catchment areas of the intervention health centres and one VHT purposively selected from each of the villages. Intervention arm will receive VHTs equipped with mobile phones making four scheduled home visits to women while the control arm will receive the standard care for prenatal and immediate newborn education. VHTs will discuss care for the pregnancy, danger signs in pregnancy, birth preparation, acquiring needed items for delivery and recommended newborn care practices. VHTs can also make instant telephone consultations with the midwife for a second opinion. A closed caller group for the mobile telephone consultation is already negotiated with Mobile Telephone Network (MTN) a mobile phone service provider to allow lower tariff rates. Our primary outcome variables of interest are hygienic cord care (specifically application of substances on the cord), thermal care (specifically delayed bathing of the baby soon after birth), initiation of breastfeeding within one hour and avoiding pre-lacteal feeds. Secondary outcomes like completed four antenatal visits, institutionalized delivery were also assessed.

NCT ID: NCT02017080 Recruiting - Clinical trials for Hypothyroidism in Pregnancy

Fetal Thyroid Ultrasound And Fetal Thyroid Hormones

Start date: January 2014
Phase: N/A
Study type: Observational

Non invasive methods: maternal antithyroid antibodies and ultrasound measurement of the fetal thyroid gland could be an important tool for detecting fetal thyroid dysfunction in mothers with autoimmune thyroid disease.

NCT ID: NCT02010840 Recruiting - Pregnancy Clinical Trials

The Effect of a Father Inclusive Psychoeducation Program on Postnatal Depression

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

Study hypothesis: Childbearing couples who receive the father inclusive psychoeducation program will have: (a) a lower level of depressive symptoms, (b) a higher level of marital relationship, and (c) a higher level of quality of life at 6 weeks, 6 months and one year postpartum than those who receive the usual perinatal care.

NCT ID: NCT01988168 Recruiting - Clinical trials for Postoperative Complications

Closure of Skin in ChorioAmnionitis Research Pilot Study

CSCAR
Start date: February 2014
Phase: N/A
Study type: Interventional

The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by determining the patient recruitment rate and participation rate. The objective of the full-scale trial is to determine the optimal method of skin closure after Caesarean delivery in women with chorioamnionitis, which is an acute inflammation of the membranes and chorion of the placenta, seen typically after rupture of membranes with ascending polymicrobial bacterial infection. Women in labour with chorioamnionitis will be randomized at the time of Caesarean delivery to skin closure with either staples or sutures. The women will be followed at 6 weeks and 6 months post-partum in order to establish the occurrence of surgical site infection and wound disruption, as well as evaluation of the scar and other secondary questions. The investigators hypothesis is that closure of skin with sutures will have a rate of wound infection that is no higher than the rate of wound infection when closing skin with staples. The investigators also hypothesize that closure with sutures will have a decreased rate of wound disruption, increased patient satisfaction and decreased length of hospital stay compared to skin closure with staples.

NCT ID: NCT01987141 Recruiting - Pregnancy Clinical Trials

Gestational Weight Gain and the Electronic Medical Record

WATE
Start date: October 2013
Phase: N/A
Study type: Interventional

Less than one third of pregnant women actually achieve the Institute of Medicine's (IOM) recommended weight gain. To date, there are no randomized controlled trials studying the use of the electronic medical record to alert providers to initiate the counseling of patients on the IOM gestational weight gain recommendations. In the investigator's planned study intervention, using the EPIC EMR system, an electronic alert (Best Practice Advisory) will appear for providers at each prenatal care visit. This alert will remind providers to counsel patients on the recommendations for gestational weight gain. The control group will receive standard prenatal care, without electronic alerts generated regarding BMI and gestational weight gain. The investigators hypothesize that a higher percentage of patients who receive the intervention will meet the IOM guidelines for weight gain.

NCT ID: NCT01917799 Recruiting - Pregnancy Clinical Trials

Aspirin, Heparin and Miscarriage

Start date: January 2009
Phase: Phase 4
Study type: Interventional

Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in patients with a history of recurrent miscarriages.

NCT ID: NCT01896960 Recruiting - Pregnancy Clinical Trials

ET50 With Fentanyl for Post Caesarean Section Spinal Hypotension

ET-50-Fent
Start date: July 2013
Phase: Phase 2
Study type: Interventional

Hypotension is extremely common after induction of spinal anesthesia for cesarean delivery. Anesthetic blockade of the sympathetic outflow of the spinal cord causes vasodilation, and is one cause of this hypotension. The higher the spread of the blockade will result in a higher incidence of hypotension. Injected hyperbaric medication has about 15 minutes to spread within the intrathecal space before it will be taken up by the nerve roots. The time that a patient remains in one position after medication injection will affect the spread of the resultant anesthetic block. A patient who is left sitting for a longer period of time after injection of hyperbaric medication will have a lower level of block than someone who is placed supine immediately. In this study, the investigators wish to use up down sequential analysis to determine the time period a patient should remain seated after intrathecal injection of hyperbaric bupivacaine and fentanyl that will result in a 50% rate of hypotension.

NCT ID: NCT01891240 Recruiting - Pregnancy Clinical Trials

IMproved PRegnancy Outcome by Early Detection

IMPROvED
Start date: November 2013
Phase: N/A
Study type: Observational

The overall objective of the IMPROvED project is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for preeclampsia. This will involve a multicentre, phase IIa clinical predictive study to assess and refine novel and innovative prototype tests based on emerging metabolomic and proteomic technologies developed by SMEs (small to medium size enterprise) within the consortium. The study will i) recruit 5000 first-time pregnant women; ii) establish a high calibre biobank, augmented by accurate clinical metadata; iii) determine whether prototype predictive assays and algorithms translate to the clinical environment; iv) assess potential synergy of a combined metabolomic and proteomic approach and v) progress regulatory approval and development of the selected test into the clinical arena.