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NCT07152743
Pregnancy and childbirth represent a crucial transition for couples, involving significant psychological and emotional adaptation. The World Health Organization recommends that all women have the possibility to be accompanied by a support person of their choice during labor and birth. The presence of a trusted companion can provide emotional reassurance, improve communication with health professionals, and support non-pharmacological pain management, often reducing the need for medical interventions. Fathers who attend childbirth frequently describe their participation as a meaningful and positive experience, strengthening their relationship with both the mother and the newborn. However, in the case of elective cesarean section, the father's presence in the operating room is not always allowed, especially when there is a high risk of complications (such as major hemorrhage). This variability may influence how mothers and fathers experience the birth. This qualitative, single-center, non-funded study aims to explore and describe the lived experiences of mothers and fathers regarding the presence or absence of the father during an elective cesarean section. After informed consent, couples will be invited to participate in a semi-structured interview conducted 48-72 hours after birth, during postpartum hospitalization at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. The interview, lasting approximately 20-30 minutes, will be audio-recorded and anonymized. Participants may withdraw at any time without consequences for their care. The primary objective is to describe the experience of both mothers and fathers in relation to whether the father was present or absent at the birth. Secondary objectives include: describing demographic and obstetric characteristics of participating women, exploring expectations and emotions of fathers who attended the cesarean birth and of their partners, exploring the experiences of fathers who could not be present, and of their partners, evaluating the perceived support provided by healthcare staff, identifying unexpected needs or desires expressed by participants. A purposive sample of approximately 30 couples will be recruited (15 where the father is present and 15 where he is absent). Recruitment will continue until data saturation is reached. Data will be analyzed using thematic analysis, following established qualitative research methods. This study will provide new insights into how the presence or absence of the father during elective cesarean section shapes the birth experience for both parents. The results may support policies and practices aimed at improving emotional well-being, strengthening family bonds, and enhancing the quality of maternity care.
NCT03490682
Current recommendations permit the ingestion of all clear fluids (water, apple juice, black coffee..) during labour. However, regarding food during labour, the recommendations vary. British and European guidelines permit the ingestion of low-residue food during labour whilst guidelines from the United States prohibit having any solid food during labour. The reason for this variation in recommendations is the lack of data on gastric emptying during labour with a conservative approach adopted due to the fear of delayed gastric emptying increasing the risk of regurgitation and pulmonary aspiration in the case of general anaesthesia. This study aims, therefore, to evaluate if the gastric emptying of a light meal is slowed down during labour, using a validated, non-invasive ultrasound method, in four groups of women : Women in labour with epidural analgesia (Analgesia group), women in labor without any epidural analgesia (Parturient group), women in the third trimester of pregnancy (Pregnant group) and women who are not currently pregnant (Non-pregnant control group). The investigator propose the hypothesis that the gastric emptying of a light, solid meal is slowed by 30% during labour under epidural analgesia.
NCT06587373
While a significant percentage of women in France have difficult pregnancies and negative childbirth experiences, there is still lack of documentation on the impact of these traumatic experiences on maternal health and mother-child relationships. Few studies have focused on the mental health of mothers, despite traumatic experiences being a risk factor for post-traumatic stress, depressive disorders, and suicide. The findings also highlights the maternal withdrawals and intrusions in interaction with the child, which are associated with guilt and feelings of helplessness, a risk to the emotional regulation of the child. Additionally, avoidance symptoms resulting from traumatic experiences delay mothers' seeking help and the early management of dysfunctional interactions. Therefore, assessing the mother-child interactions is important in understanding perinatal psychopathology.
NCT02408588
Using a pulse oximeter, the investigators have developed an algorithm that assesses central volume status. Pregnant women present some unique opportunities for us to investigate the algorithm under different circumstances. The investigators want to specifically investigate an algorithm with women who undergo regional anesthesia such as epidurals, with women who undergo fetal surgery, and with women in labor and giving birth (and the recovery time following delivery). This will help the investigators understand the central volume status changes that women experience in these unique circumstances. The Investigators also want to put the pulse oximeter on the fetal hand when possible during certain maternal fetal interventions. The Investigators would like to examine the algorithm with data from the fetuses.
NCT05820958
The goal of this clinical trial is to test the influence of intensified tactile contact between mother and newborn on the direction of the emotional transformation of the mother from the physiological, undisturbed delivery to 12 weeks postpartum. The participants will deliver intensified tactile stimulation to their newborns in the form of Shantali massage at least 2 times a day. Researchers will compare the results obtained in the intervention group to the control group in which participants voluntarily did not agree to introduce more intensive tactile contact with the child. The main question the study aims to answer is: Is the direction of the mother's emotional transformation different after the intensification of tactile contact with the newborn in comparison to the control group?
NCT04411745
This is a prospective observational study on normal singleton pregnant women who have no sign of labor at 40 weeks of gestation or pregnant women who admitted to hospital for any sign of labor at term, aiming to identify labor-associated markers.
NCT00323401
1. To study the influence of antenatal classes for first time parents and their effect ob pregnancy, birth and parenthood. 2. Randomized into two groups (a. 3 courses in midpregnancy and b. no courses) 3. Data on pregnancy, birth and parenthood are collected from register and questionaire
NCT02870712
During childbirth, the recommendations have evolved to a restriction of episiotomy. This reduction results in an increase of superficial vaginal and perineal tears. These lesions are usually routinely sutured which often causes the onset of discomfort and pain in the immediate postpartum period. Gordon showed, in 1998, improved comfort and pain when the skin was not sutured perineal tears during the second degree. Others have compared different techniques in the same indications (separated points running suture, biological adhesive) without demonstrated impact. These studies were not interested in isolated perineal tears or first degree or the application of a simple manual compression with or without a suture according to the result of hemostasis. Our objective is to evaluate the possibility of not suture the perineum of the first degree. The use of suture only result of bleeding not yielding to manual compression. Our approach is guided by the principles of "primum non nocere" and discerning about the dogmatic systematization.
NCT04657107
During the past years, a large number of clinical trials have investigated the use of the non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist racemic ketamine as an adjunct to local anaesthetics, opioids, or other analgesic agents for the management and prevention of postoperative pain. Actually racemic ketamine not only abolishes peripheral afferent noxious stimulation, but can also prevent the central nociceptor sensitization. S-ketamine, one of two enantiomers of racemic ketamine, has twice the analgesic potency of the racemate. Moreover, S-ketamine shows smaller nervous system and less psychotropic effects than racemic ketamine , which may make the drug more suitable for clinical use. Recently, S-ketamine has been approved to treat refractory depression (TRD) and major depressive disorder (MDD) by the FDA .S-ketamine may have greater clinical significance due to the high rate of maternal depression. Therefore, we plan to explore whether clinical use of S-ketamine can optimize anesthesia protocol and improve maternal prognosis.
NCT03890276
The goal of this study is to ensure that the training materials and methods for the training module Helping Mothers Survive Essential Care for Labor \& Birth (ECL\&B) are usable and acceptable by trainers and healthcare providers in Zanzibar. Findings from this study will be used to improve the modules and validate the trainee assessments. This study also compares provider learning outcomes in the training module delivered with and without video demonstration. Focusing on the first two phases of the Kirkpatrick model, the field validation will answer the following research questions: 1. How acceptable and appropriate for adequate teaching and learning is the training module? 2. What is the gain in knowledge, clinical decision-making, communication, and psychomotor skills of the trainees from pre to post-training assessment? (immediate learner outcomes) 3. Is there a difference in immediate learner outcomes in training where video clips are used during training to supplement live trainer demonstration compared to training where video is not used as a supplement?
NCT01131260
The purpose of this research is to test a new instrument, called a fetal STAN monitor, that may be used during labor to monitor the electrical activity of the baby's heart. This new instrument is designed to help the doctor determine how well the baby is doing during labor. It will be used along with the existing electronic fetal monitor used to measure the baby's heart rate and the mother's contractions during birth. The specific purpose of this research study is to see if this new instrument (fetal STAN monitor) will have an impact on newborn health.
NCT02363036
Accumulating evidence suggest that the proliferative, invasive, and immune tolerance mechanisms that malignant tumors use to establish a nutrient supply and evade or edit the host immune response are similar to those used by the developing placenta during normal pregnancy. In addition to the shared capacity for invading through normal tissues, both cancer cells and cells of the developing placenta create a microenvironment supportive of both immunologic privilege and angiogenesis. CD11b+Gr1+ cells are a heterogeneous population of bone marrow-derived cells (BMDC) that consist of immature myeloid cells (IMCs), and were first described as myeloid-derived suppressor cells. In healthy individuals, IMCs that are generated in the bone marrow differentiate into mature granulocytes, macrophages, or dendritic cells (DCs). These cells have been shown to play an essential role in mediating immune suppression in animal models of human tumors. As a result of tumor-induced alterations in myelopoiesis, IMCs have been found in peripheral blood, lymphoid organs and the tumor tissue itself. An increased population of IMCs was identified in patients with several tumor types. Accordingly, IMCs detected in the peripheral blood of such patients bearing express the common myeloid marker CD33 but lack markers of mature myeloid cells such as the MHC class II molecule HLADR. IMCs have been shown to actively promote tumor growth and metastasis by modulating the cytokine environment, and through vascular remodeling by promoting angiogenesis. It has been demonstrated in our laboratory that IMCs infiltrate placentas of pregnant mice and actively promote angiogenesis. These cells show striking similarity to IMCs that populate malignant tumors. Accordingly, human placentas are also infiltrated by a significant population of IMCs. Immunostaining of human placentas showed that IMCs comprise around 25% ( range 10-40%) of total placental CD45+ bone marrow-derived hematopoietic cells and that this population is located close to blood capillaries. We also demonstrated that immature DCs, cells originally described to regulate the adaptive immune response, also promote angiogenesis in models of choroidal neovascularization, endometriosis and tumors. This is a retrospective study on patient's blood samples of pregnant women who came to delivery in our department during 1.1.2014-31.12.2014, to compare the abundance of monocytes and neutrophils in: 1. Term active labor. 2. Elective cesarean section. According to our previous findings, we hypothesize that monocytes in active delivery will be lower than in women without signs for labor. We also hypothesize that neutrophils will be more abundant in active delivery than in women without signs for labor. We plan to screen anonymous electronic data of women who delivered in our departement during 2014 according to the following eligible criteria, stratified into 2 categories: 1. Women who were admitted in active labor. 2. Women who were admitted for elective Cesarean Section without signs of labor. We will compare the abundance of monocytes and neutrophils in blood counts that were taken on admission day between the two populations.
NCT01051726
Aromatherapy is a form of complementary medicine that uses scented materials known as essential oils for the purpose of affecting a person's health or mood. Although aromatherapy has been used in childbirth for centuries, there are no high-quality studies examining whether the treatment works. Methodology We would like to see if aromatherapy affects a woman's experience of childbirth by lowering associated anxiety and pain. Consenting participants will be randomly allocated to one of these groups: 1. Aromatherapy oils (e.g. clary sage, peppermint, lavender, frankincense) 2. Non-essential oil (baby oil) 3. Standard maternity care We will gather primary data, e.g. if she's been in labour before and her awareness of complementary medicine. We will also conduct the Spielberger State-Trait Anxiety Inventory with her, and provide her with the oil and swab if she is in groups 1 or 2 with instructions to keep the swab with the oil on it near to her. She can also put more oil on the swab as she requires. Postnatally, data will be collected from her notes regarding pain relief used, duration of labour, augmentation of labour, and any other medical interventions of note. We will also complete the anxiety scale with her once more. Before her discharge we ask the mother for any comments regarding her experience of the labour. The results from all three cohorts will then be compared. There will also be opportunity for the midwife to make any comments regarding his/her perception of the participant's labour. Finally we will hold a focus group with midwives regarding the practicalities for implementation of aromatherapy in maternity care
NCT01164657
Background: The World Health Organization (WHO) advises against recumbent or supine position for longer periods during labour and birth and states that caregivers should encourage and support the woman to take the position she finds most comfortable. It has been suggested that upright positions may improve childbirth outcomes and reduce the risk for instrumental delivery. Objective: The primary objective was to test the hypothesis that birthing on the "BirthRite" ® seat will result in a reduction in the number of primiparous women delivered instrumentally. Method: A power calculation showed (α = 0.05 β = 0.2) a requirement of 460 participants in each of the two arms of the trial in order to test for a 40% reduction (from 15% to 9%) of instrumental deliveries in primiparous women at a maternity unit in southern Sweden. It was decided to subject the study to a feasibility test by conducting a pilot-study in which 68 women were randomised to give birth on the birthing seat or to give birth in any other position but on the "BirthRite" ® seat. Randomization to birth on the birthing seat or in any other position took place when the participant's cervix was fully dilated. The primary outcome measurement was the number of instrumental deliveries. Secondary outcome measurements included oxytocin augmentation, perineal trauma, and blood loss administration of oxytocin for augmentation of labour, length of the second stage of labour, perineal trauma, perineal oedema, maternal blood loss and haemoglobin, apgar scores, cord pH and transfers to the Neonatal Intensive Care Unit(NICU).