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NCT06976632
The purpose of this study is to investigate the effect of local cold application using the Helfer Skin Tap Technique on pain levels during the intramuscular injection of the tetanus vaccine in pregnant women. The study will also record vital signs, which are among the physiological effects of pain.
NCT06523543
Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.
NCT07467837
PRIME Mothers is a national observational trial designed to evaluate patient outcomes with Stratamark® for the prevention of stretch marks during pregnancy and the postpartum period. The study is designed to fit seamlessly into routine clinical practice, with digital follow-up and home resupply, minimising clinic involvement.
NCT06357546
The hypothesis of this trial is that the absence of systematic bladder catheterization in patients performing spontaneous urination in the hour preceding the planned cesarean section under spinal anesthesia would not lead to more bladder heterocatheterization for postpartum urinary retention (RUPP) in the 24 hours post-cesarean section than systematic intraoperative bladder catheterization up to 2 hours post-surgery.
NCT07448025
In France in 2021, 90% of pregnant women chose to undergo screening for Trisomy 21, and 128,958 women benefited from a fetal aneuploidy screening test based on the analysis of cell-free DNA (cfDNA) in maternal blood. At the beginning of its use, this analysis was limited to screening for Trisomy 21, but it now allows the study of all chromosomes (expanded screening). More than half of fetal chromosomal abnormality screenings are expanded tests, and this practice continues to grow. In oncology, circulating tumor DNA (ctDNA) is studied for the detection, prognostic evaluation, and monitoring of the effectiveness of certain treatments. The high-throughput sequencing tools used for aneuploidy screening during pregnancy are likely to detect malignant diseases. Cancer is associated with pregnancy in 1 in 1,000 to 1 in 1,500 pregnant women, and the spread of expanded aneuploidy screening during pregnancy makes it possible to detect maternal cancers, including at infraclinical stages. This study will therefore help manage situations involving difficult-to-interpret results, such as suspected maternal cancer. It will make it possible to identify specific chromosomal abnormalities to be tested, which could potentially be included in future recommendations. In a second stage, it could contribute to harmonizing the practices of laboratory specialists performing fetal chromosomal abnormality screening using cfDNA.
NCT07372313
Anesthesia for cesarean delivery can be provided through general or neuraxial anesthesia (spinal or epidural). Hypotension is a common complication of both methods. Hypotension associated with spinal anesthesia can cause dizziness, nausea, vomiting, restlessness, and confusion in the mother, while also decreasing blood flow to the baby, leading to hypoxia and fetal acidosis. Untreated persistent hypotension poses a life-threatening risk to both mother and baby. In recent years, ultrasonography has become widely used to assess volume status. Carotid artery corrected flow time (FTc) is primarily affected by left ventricular preload and is related to myocardial contractility and afterload. Therefore, it can predict intraoperative hypotension. Postdural puncture headache (PDPH) is a relatively common complication after neuraxial blocks. PDPH is generally defined as an orthostatic headache caused by low cerebrospinal fluid pressure accompanied by neck pain, tinnitus, hearing changes, photophobia, and/or nausea. Risk factors include female gender, young age, pregnancy, a previous history of PDPH, low CSF pressure, and low BMI. This study will be conducted on pregnant women undergoing elective cesarean sections under spinal anesthesia in the cesarean operating room at Erciyes University Faculty of Medicine Hospital. The correlation between preoperative carotid artery FTc levels in pregnant women and the incidence of intraoperative hypotension and postoperative PDPH will be investigated, as will whether FTc levels are a significant predictor of the likelihood of developing intraoperative hypotension and postoperative PDPH. Carotid artery FTc will be measured 1 hour before surgery, and baseline systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), peripheral oxygen saturation (SPO2), and heart rate will be recorded in the operating room. Values will be recorded at 1, 2, 3, 5, 10, 12, 15, and 30 minutes after spinal anesthesia. Patients will be assessed postoperatively for postdural puncture headache using a numerical rating scale (NRS) on days 2, 3, and 7. This study is expected to demonstrate the ability of preoperative FTc to predict hypotension and PDPH, to determine the threshold value for predicting hypotension and PDPH, and to improve or modify the anesthesia method in patients with predicted hypotension and PDPH.
NCT07310680
Anemia in pregnancy can result in negative pregnancy outcomes, which are higher among pregnant women of rural Bangladesh. A cost-effective health education program is urgently needed to introduce, which will help to improve their hemoglobin level by changing their lifestyle. In many rural settings, mobile-based health (mHealth) education programs have been shown to improve hemoglobin levels effectively during the antenatal period. So, we aim to assess the impact of a mHealth education program on improving hemoglobin levels among anemic pregnant women of rural Bangladesh. The study will be carried out in the rural settings of a district of Bangladesh named Chandpur. This study timeline is from December 2025 to May 2026. After this survey, a randomized controlled trial study will be conducted where 160 pregnant women who are diagnosed with mild and moderate anemia will be offered to participate. Pregnant women who will give informed consent will be randomly assigned to two arms: intervention and control. Every arm will have an equal number of anemic pregnant women. Pregnant women in the intervention arm will receive anemia management-related health education through mobile messages and calls. This intervention program will educate pregnant women about the causes, risks, and symptoms of anemia, with the prevention strategies like dietary improvement, supplementation, parasitic disease control, safe motherhood, family planning, and iron-rich food production. Additionally, they will get regular care, a booklet and reminders of ANC visits during the study period. In contrast, the pregnant women of the control arm will receive regular care during this period, but after the end-line assessment, they will also get the booklet. After 4 months of the intervention program, the end-line assessment will be done, where the hemoglobin, nutritional status, and literacy about anemia will be assessed. Multiple comparisons will be performed by two-way analysis of variance tests for the evaluation of the outcome variables. Additionally, a Generalized Estimating Equations (GEE) model will be used to analyze the effect of the mHealth education program on related factors. A p-value less than 0.5 will be considered significant in this study. If this mHealth-based education program shows improvement in hemoglobin level, this can be utilized in low-resource settings widely to ensure safe pregnancy outcomes in the future.
NCT07307196
Infertility treatment is a long and challenging process. Women who become pregnant after this process may experience stress, anxiety and intense concerns about the baby's health alongside their happiness. These feelings can negatively affect the mother's adjustment to pregnancy and her psychological well-being. This study was designed to examine the effects of the Mindfulness-Based Stress Reduction (MBSR) programme, administered to women who became pregnant after infertility treatment, on: stress levels during pregnancy, adaptation to pregnancy, and foetal (baby's health-related) anxiety. Pregnant women participating in the study will be divided into two groups: an experimental group and a control group. Women in the experimental group will receive mindfulness-based stress reduction training lasting approximately 4 weeks. This programme includes breathing exercises, meditation, body awareness, self-compassion exercises, and practices aimed at strengthening the mother-baby bond. The control group will not receive any training during this period. Translated with DeepL.com (free version)
NCT07199140
Study Type and Aim: This clinical study aims to examine the effects of haptonomy practices on appreciation of bodily functionality and childbirth self-efficacy among healthy pregnant women. The study seeks to determine whether haptonomy can enhance these two outcomes. Key Research Questions: Do haptonomy practices increase appreciation of bodily functionality in pregnant women? Do haptonomy practices increase childbirth self-efficacy in pregnant women? Comparison: Researchers will compare an intervention group receiving haptonomy sessions with a control group receiving only routine prenatal care to evaluate the effects of the intervention. Participants will: Participants will provide written informed consent to take part in the study. Pregnant women in the intervention group will attend four haptonomy sessions, each lasting approximately 45 minutes and held at 7-day intervals. Sessions will include practices to enhance body awareness, relaxation techniques, connecting with the baby, and affirmations supporting bodily functionality and childbirth self-efficacy. Pregnant women in the control group will receive routine prenatal care and follow-up only. All participants will complete pretest and posttest measures assessing appreciation of bodily functionality and childbirth self-efficacy. Keywords: Haptonomy, Vaginal birth, Pregnancy, Prenatal care, Body functionality appreciation, Birth self-efficacy
NCT02229630
The purpose of this study is to compare the apparent diffusion coefficient in the frontal lobe of foetuses with intra-uterine growth restriction and poor neonatal outcome compared with foetuses with intra-uterine growth restriction and a good neonatal outcome.
NCT07084103
This study aims to evaluate the effectiveness of a psychosocial support intervention for women diagnosed with fetal anomaly. A randomized controlled trial design will be used, and women diagnosed with fetal anomaly will be included as participants. The intervention group will receive a structured psychosocial support program, while the control group will receive routine care.
NCT07003971
The aim of this study is to examine the effectiveness of a programme to improve healthy lifestyle behaviours based on the Health Belief Model to be offered through Instagram, a social media platform. For this purpose, it is aimed to produce content containing accurate and evidence-based information for pregnant women on social media, to ensure that pregnant women can access the right information quickly and easily, to adopt healthy lifestyle behaviours, to test the effectiveness of the social media platform for the adoption of healthy lifestyle behaviours and to contribute to the formation of a healthier family and society in the long term. In addition, this study is aimed to create a model for the midwifery profession to benefit from the new opportunities created by internet technology outside the clinical field in service delivery. The population of the study will consist of women with primiparous pregnancies in the first and second trimester. Women who agree to participate in the study will be randomly assigned to the experimental and control groups. In addition to routine care and counselling, pregnant women in the experimental group will receive support for developing healthy lifestyle behaviours through Instagram, while the control group will receive only standard pregnancy care and counselling services approved by the Ministry of Health. General Hypothesis of the Study: H1: The Healthy Lifestyle Behaviours development programme offered through the social media platform Instagram is effective in providing a positive development on healthy lifestyle behaviours in pregnant women.
NCT06930469
A randomized controlled trial was conducted with 100 critically ill pregnant women admitted to our hospital's obstetrics ICU between January 2023 and December 2024. Participants were allocated via random number table to either the control group receiving conventional multidisciplinary resuscitation care (n=50) or the observation group receiving the structured team model with shared decision-making (n=50). Comparative outcomes included resuscitation efficiency indicators (pre-hospital response time, intrahospital transport duration, emergency supply preparation time), complication rates, family psychological status measured by Hospital Anxiety and Depression Scale (HADS), and family satisfaction assessments
NCT06921954
The themes of city-hospital coordination, patient pathways and the decompartmentalization of the city-hospital-medical-social and social sectors are becoming a major preoccupation for the healthcare sector, and a key factor in its dynamic transformation. A number of initiatives taken in this direction, either by the regulatory authorities (development of tools to promote coordination between healthcare professionals), by hospital establishments or by city professionals (notably CPTS), attest to a growing interest in the subject. The École des Mines de Paris, whose highly collaborative research methods (research-intervention) are anchored in concrete support for transformation projects, and the University of Lille (LUMEN) are thus increasingly called upon to support players in these areas. In this context, collaborative work with a Quebec research team (Ecole Nationale d'Administration Publique and Université de Sherbrooke) was launched in 2023 to compare forms of healthcare pathway management between two different healthcare systems, and their effects on vulnerable people (elderly, disabled, migrants, homeless, etc.). In France, the quantitative component is based on the use of PMSI databases, and aims to analyze the characteristics of "abnormally long" patient stays, in order to identify variables (relating either to patients or to care) likely to explain longer lengths of stay. The qualitative component is based on interviews with professionals and the reconstruction of patient pathways marked by breaks in care. The aim is to understand the very notion of breakdowns, the mechanisms by which they occur and the strategies put in place to avoid or deal with them. Collaboration with the PRECAPP research team As part of the qualitative component of the research program, the French team met several times between February and summer 2024 with members of the PRECAPP program. The PRECAPP system's function (to support vulnerable pregnant women in the perinatal period) and its mission (to identify the risks of disruption to care as early as possible in pregnancy, and to coordinate care during pregnancy and in the postnatal period) are at the heart of the Franco-Quebec research. An initial working meeting between the PRECAPP team and the researchers provided an opportunity to describe the system and to demonstrate that its operation and the specific support it provides make it possible to anticipate certain difficulties in the care of women (before, during and after birth) and to help avoid disruptions in care. The PRECAPP system is therefore fully in line with a comprehensive approach to the perinatal care of precarious and vulnerable women. This care concerns intra-hospital care, but it also contributes to the decompartmentalization of city-hospital care. It is with the aim of highlighting the contributions of the PRECAPP system to the quality of care provided, the limits to its action, and to assess the way in which it helps to avoid breakdowns, that a collaboration between researchers and practitioners has been set up and will enable this study to be carried out.
NCT06844929
Women who meet the sampling selection criteria will be introduced and informed about the study. Considering the patients who meet the research criteria and accept the study, patients will be divided into groups according to whether their barcode numbers are odd or even (1:1 ratio), provided that the number of individuals in the intervention and control groups is equal. It is planned to work with a total of 80 pregnant women, considering the losses. The intervention and control groups will be selected by drawing lots. The Introductory Information Form and Prenatal Breastfeeding Self-Efficacy Scale will be filled out by the women who meet the sampling selection criteria and accept to participate in the study before the application. The content of the podcast-based education to be given to the pregnant women in the intervention group will be created by the researcher and the consultant, and expert opinion will be obtained regarding the content. For the pregnant women in the control group; a brochure will be prepared for breastfeeding education and expert opinion will be obtained. The brochure prepared by the researcher and the consultant will be given to the pregnant women in the control group at the planned time. The pregnant women in the intervention group will be given a period of two weeks to complete the prepared podcast education. At the end of the two-week period, pregnant women in the intervention and control groups will be asked to fill out the Prenatal Breastfeeding Self-Efficacy Scale again.
NCT06746662
This study aimed to investigate the effects of counseling based on hypno-breastfeeding philosophy on breastfeeding self-efficacy and breastfeeding success in pregnant adolescents. Research Hypotheses H1a: The intervention group\'s breastfeeding self-efficacy after hypno-breastfeeding counseling is different from the control group. H1b: The intervention group\'s breastfeeding success after hypno-breastfeeding counseling is different from the control group. This thesis is a randomized controlled experimental study. The study is planned to be conducted with two parallel groups, namely the intervention and control groups. Hypno-breastfeeding training will be applied to the intervention group, and standard breastfeeding training will be applied to the control group. The study will be conducted with pregnant adolescents who applied to the pregnancy clinic of Adıyaman University Training and Research Hospital between December 2024 and April 2025.
NCT06799689
Pregnancy is a normal and natural process in a woman's life. During this process, anatomical, physiological, biochemical and emotional changes are observed. The changes are a period in which social, biophysical and psychological changes are experienced, which also means a journey into the unknown for the woman and her family. Although the scope of prenatal care is high today, the main focus is on the physical aspects of care and medical precautions. Midwives who provide holistic care should also address spiritual care. Therefore, the ESMADEM training model will be conducted to examine the effect of the spiritual coping, prenatal attachment and fear of birth of pregnant women.
NCT04212234
Ultrasound (US) image construction uses equations that contain the value of the propagation velocity of sound waves; this velocity is assumed conventionally to be constant and equal to 1540 m/s in the human body. Since 1977, all manufacturers of US scanners have used this value, which was first established in 1950. In fatty tissue, however, the actual propagation velocity is only in the order of 1450 m/s. US velocity in fat tissue is slower than in other soft tissues (ie:1450 m/s vs 1540 m/s) therefore the intrinsic image quality in terms of sharpness and precision is improved when considering this parameter for image construction The main objective of this study is to evaluate the impact of ultrasound propagation velocity setting on completeness of ultrasound exams and images quality during the second and third trimester fetal ultrasound examination in obese patients.
NCT06750523
All factors that influence the peak bone mass achieved at skeletal maturity are important in determining an individual's risk of developing osteoporosis later in life. Bone health begins with maternal health and nutrition, which influence skeletal mass and bone density in utero. The mechanisms underlying the effect of the intrauterine environment on bone health are currently unknown, but certainly include 'fetal programming' of oxidative stress and endocrine systems, as these influence skeletal growth and development later in life. For the prevention of bone health, the challenges rely 1) in the need for new technology and software specific and applicable to the fetus and newborn; 2) in establishing the effect of environmental contaminants, in particular endocrine disruptors, oxidative stress and subsequent epigenetic changes in mothers and subsequently on the fetus, newborn and infant.
NCT06641479
With the implementation of China's universal two-child policy and a notable rise in adverse pregnancy outcomes, leveraging electronic health records (EHR) has become crucial for enhancing maternal health. Given the mature construction of the information platform and the well-established maternal and child health service system in Jiangsu Province, this study used the Jiangsu Health Information Platform to carry out the research on the JiAngSu Maternal and INfant hEalth database (JASMINE), which involved over 1.5 million mother-child pairs in Jiangsu Province. JASMINE enables longitudinal follow-up of pregnant women and their offspring, facilitating the exploration of early-life exposures and their long-term outcomes through comprehensive data linkage. This longitudinal approach helps to clarify the relationship and etiological significance of risk factors associated with adverse pregnancy outcomes.It also permits the exploration of the health trajectory of women and children throughout their lives. From January 2020 to December 2023, JASMINE has recorded extensive maternal and child health data, including socio-demographics, healthcare services, medications, and clinical outcomes.Additionally, it contains longitudinal measurements on risk factors for adverse pregnancy outcomes, which provides a robust foundation for future real-world studies of dynamic predictive models. This study has been approved approved by the Institutional Review Board of Nanjing Medical University. Ultimately, this research aims to identify key predictors of adverse pregnancy outcomes and inform public health policies to improve maternal and child health in Jiangsu Province. Future directions will include developing targeted interventions based on study findings to enhance health outcomes for mothers and infants.