Clinical Research Directory

THROmbinography in Pregnant Woman and in Vitro Action of Low Molecular Weight HEparin

Pregnancy is associated with major changes affecting all satges of hemostasis. Certain procoagulant factors are increased, such as factors VII, VIII, IX, X, XII, fibrinogen and Von Willebrand factor. Anticoagulant molecules are also affected by pregnancy, notably the protein C - protein S (PC - PS) system. overall, PC activity is little affected by pregnancy, increasing in the 2nd trimester and decreasing in the 3rd, but remaining within normal values. PS decreases from the first trimester of pregnancy, then progressively with gestational age. Antithrombin is stable during pregnancy. The increased in most coagulation factors, combined with the decrease in concentrations of anticoagulant molecules, creates a state of relative hypercoagulability that protects women from bleeding during homostatic challenge of childbirth, but predisposes them to venous thromboembolic events. The risk of venous thromboembolism (VTE) during pregnancy is increased compared to non-pregnant women of the same age. The post-partum period is also considered a thrombotic risk state for up to 12 weeks after delivery. Data on the incidence of VTE as a function of gestational age are contradictory: depending on the study, incidence may be stable or increase with advancing pregnancy. Low-molecular-weight heparin (LMWH) is the anticoagulant treatment of choice for prophylactic or curative treatment of VTE during pregnancy. Physiological changes during pregnancy may alter the pharmacokinetic properties of LMWH. The increased volume of distribution and higher glomerular filtration rate may result in a reduced anticoagulant effect. On the other hand, the state of hypercoagulability probably counteracts the anticoagulant effect of LMWH. Nevertheless, the need to adjust doses during pregnancy remains controversial, and monitoring of anti-Xa activity is not clearly recommended. The optimal dose of LMWH in pregnant women, for both preventive and curative treatment, remains poorly understood. Initiation of treatment with LMWH therefore requires discussion of the dosage to be administered. Assessment of anticoagulation using more precise tools than those currently available on a routine basis could be useful in this context. Thrombinography enables the amount of thrombin generated in the presence of coagulation activators to be assessed over time. This tool can be used to assess the impact of in vitro addition of different doses of LMWH in pregnant versus non-pregnant women and in the postpartum period. In this pilot study, the investigators propose to evaluate thrombin generation, before and after in vitro addition of LMWH, in pregnant women longitudinally, during the 3 trimesters of pregnancy, postpartum and post-pregnancy.

Testing Effects of Melatonin on Uterine Contractions in Women

The study will extend recent discoveries that have been made in basic human physiology related to responses melatonin and uterine contractions in late- or full-term pregnant women. The basic physiology work has been conducted in in vitro models of the human myometrium characterizing its responses to melatonin, and in pilot in vivo studies correlating the number of uterine contractions with melatonin concentrations that were manipulated by different types of light exposure. The planned experiments will test a causal link between circulating melatonin levels and uterine contractions in full-term pregnant women by manipulating melatonin levels using exogenous melatonin (i) during the day when endogenous levels of melatonin are very low (Experiment 1), and (ii) during the evening under conditions with lighting that would be expected to suppress the higher evening and nighttime levels of endogenous melatonin (Experiment 2).

A Research Comparing Efficacy of PIEB Plus PCEA vs CEI Plus PCEA for Labour Analgesia

During labour process, one of the most effective ways to manage pain is via epidural analgesia. It is commonly and widely use for all pregnant women underwent labour process. It provides good pain relief during labour process especially for contraction pain and pain during descending of baby during delivery. During epidural insertion, a small catheter (which is flexible and thin) will be inserted via epidural needle at the back. Using this epidural catheter, pain medication will be given to ease and help controlling the pain. This procedure is usually done after you have been admitted to labour room. In this research, investigator will compare among two different method of epidural administration which are: \- Programmed Intermittent Epidural Bolus with Patient-Controlled Epidural Analgesia (PIEB + PCEA): * This method will enable the medication to be served automatically within the set time through the epidural catheter and allows for participants to manage additional boluses of medication according to the participants pain level. \- Continuous Epidural Infusion with Patient-Controlled Epidural Analgesia (CEI + PCEA): * This method will deliver continuous infusion of medication and allows for participants to manage additional boluses of medication according to the participants pain level. Investigator want to determine the best method between this two in order to have better pain control, less usage of medication and improving the satisfaction of patient. In participating this research, the participants will help us in understanding the best method to be use for the labour process in which eventually help other future patient who is in need.

Prenatal Yoga Intervention in Pregnant Women

The aim of this study is to determine the effects of a prenatal yoga intervention on traumatic childbirth perception, self-perception, and delivery preferences in pregnant women.

Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB

The aim goal of this study is to compare the duration of induction and labor between outpatient and inpatient care in low-risk pregnant women. The secondary objectives are to compare between the two groups the maternal satisfaction from induction to delivery, the maternal and neonatal morbidity and mortality, impact on service organization and a medico-economic evaluation (cost-consequence analysis) from a collective perspective and with a time horizon of one month For women who do not agree to take part in the randomized study, an observational study will be proposed to them in order to collect the reason for their refusal and their maternal satisfaction. Researchers will compare the return home with conventional hospitalization Patients presenting with a singleton pregnancy and with an indication for induction of labor will be proposed to participate in the study. If the pregnant woman refuses to participate in the randomized study, she will be invited to take part in the observational study. For women who accept, a fetal heart rate recording (FHRR) is made prior to balloon insertion. If there is no fetal heart rhythm abnormality (FHR), the double balloon catheter is inserted by a midwife. A further ERCF is performed to ensure that the procedure is well tolerated. In the absence of metrorrhagia, fetal heart rate abnormalities, rupture of the water sac or uterine hypertonia/hyperkinesia, the patient will then be randomized to either the in-patient or out-patient arm. The patient will either be placed in a room or go home. In both cases, the balloon will be removed after 24 hours in hospital in the absence of spontaneous labor, and the patient will be referred to the delivery room for water breakage and/or oxytocin infusion for induction.

Quality of Life in Breast Cancer Survivors Who Were Pregnant During Their Cancer Treatment

To assess the quality of life for women who were pregnant during their breast cancer treatment.

Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Versus Valaciclovir

The investigators' hypothesis is that maternal treatment with Letermovir will inhibit fetal CMV replication better than Valaciclovir in infected fetuses and lead to a higher proportion of negative CMV PCR at birth in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP). The main objective is to demonstrate that Letermovir administered to women carrying a CMV infected fetus following a maternal infection of the first trimester increases the proportion of neonates with a negative CMV PCR in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP) compared to Valaciclovir. In each group , the proportion of asymptomatic neonates and the number and type of long-term sequelae at 2 years will also be assessed and compared.

THE EFFECT OF HAPTONOMY PRACTICE ON PREGNANT WOMEN WITH A HISTORY OF ABORTION.

Pregnancy is a period of comprehensive adaptation for a woman in physiological, psychological, and social terms. During this process, physical and mental transformations occur due to hormonal changes; multifaceted changes emerge, such as adopting the role of motherhood, developing a new sense of identity, and adapting to increased responsibilities. These changes during pregnancy affect not only the mother but also the fetus. Especially from the 26th week of pregnancy onwards, with the development of the fetus's auditory and sensory perception capacity, a process of reciprocal interaction begins between mother and fetus. This early interaction forms the basis of prenatal bonding.Prenatal bonding is a dynamic process involving behaviors such as the mother developing emotional closeness towards the fetus, talking to it, making contact, and preparing for care. This bonding directly affects the post-natal mother-baby relationship. However, prenatal bonding is influenced by many factors such as anxiety, stress, history of psychiatric illness, pregnancy complications, socioeconomic status, social support, and previous pregnancy experiences. Women who have experienced prenatal loss (abortion, stillbirth, neonatal death) frequently experience increased anxiety, stress, and difficulty bonding in subsequent pregnancies. High levels of uncertainty, fear, and anxiety in these individuals can negatively impact both the pregnancy and postpartum periods. The literature indicates that women who have experienced prenatal loss have lower levels of prenatal bonding and increased risks of anxiety and depression compared to those who have had healthy pregnancies. Increased stress and anxiety during the prenatal period have also been shown to be associated with negative outcomes such as low birth weight, premature birth, and neurodevelopmental problems. Therefore, supporting psychological well-being during pregnancy is critically important.In this context, interventions aimed at strengthening the bond between mother and fetus are gaining importance. Haptonomy, as a touch-based approach, is a holistic method that supports the establishment of emotional bonds between mother, father, and fetus. This method aims to develop trust-based communication by prioritizing the physical and emotional acceptance of the individual's presence. In haptonomy practices, the goal is for expectant mothers to first increase their own bodily and emotional awareness, and then to establish a conscious interaction with the fetus. Studies show that haptonomy reduces stress, anxiety, and fear of childbirth in pregnant women, while increasing prenatal bonding levels. It is also reported to have positive effects on newborns, improving their adaptation to environmental stimuli. However, the number of studies on haptonomy is limited, and research is needed, particularly focusing on its effects in pregnant women who have experienced prenatal loss. The aim of this research is to examine the effect of haptonomy on prenatal bonding and anxiety levels in pregnant women who have experienced abortion. It is hypothesized that haptonomy may strengthen mother-fetus bonding by reducing negative emotions experienced during pregnancy after a loss. The findings are expected to contribute to evidence-based care approaches applicable to high-risk pregnancy groups.

Effect of Helfer Skin Tap and Cold Application on Pain and Hemodynamics During Vaccination

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.

Ultra-early Identification of Fetal Chromosomal Characteristics From Extravillous-trophoblast Cells

Demonstrate the efficacy of an ultra-early, non-invasive prenatal diagnostic method adaptable to various genetic indications to detect fetal chromosomal abnormalities.

Prevention of Stretch Marks in Expectant Mothers

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.

Evaluation of the Absence of Intraoperative Bladder Catheterization in Case of Planned Cesarean Section

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.

Oral Health Education for Pregnant Women

The goal of this research is to investigate oral health knowledge in pregnant women receiving care at Hospital La Fe and to see whether a one-time informational intervention improves this knowledge. The main questions this research aims to answer are: What is the level of oral health knowledge among pregnant women attending Hospital La Fe? Does a one-time informational intervention, delivered through a printed leaflet, improve oral health knowledge during pregnancy? What factors are related to differences in oral health knowledge among pregnant women? Participants are pregnant women receiving care at Hospital La Fe. They will: Complete a questionnaire about their oral health knowledge. Receive a printed informational leaflet about oral health during pregnancy. Complete the same questionnaire again after a period of time to see if their knowledge has changed. Researchers will compare answers before and after the leaflet is provided to see whether oral health knowledge improves. They will also explore which personal or social factors are linked to different levels of oral health knowledge.

Physical Acvitiy in Pregnancy

The goal of this observational study is to learn how a physically active lifestyle during pregnancy affects placental development and function. The main question it aims to answer is: Does regular physical activity during pregnancy improve placental function and support healthy fetal growth? Pregnant participants will provide biological samples and health information during pregnancy and at delivery. The study will use these samples to examine how activity levels relate to placental energy production and overall health.

Gastric Ultrasound Before Elective Cesarean Section

Due to the physiologically delayed gastric emptying in pregnant women, the potential risk of aspiration before cesarean delivery constitutes an important source of perioperative complications, and when it occurs, it is associated with increased maternal morbidity and/or mortality. Systematic reviews and meta-analyses have demonstrated that, compared with non-pregnant women, gastric emptying is delayed particularly during the first trimester of pregnancy, and that gastric emptying does not occur in cases who have consumed solid food within the last 8 hours and in whom labor has begun. This study aims to evaluate preoperative gastric volumes by ultrasonography in ASA II pregnant women (according to the American Society of Anesthesiologists classification, healthy parturients without complications) scheduled to undergo elective cesarean delivery under general or spinal anesthesia, based on different fasting durations for solid and liquid intake, with the type of liquid. Although previous research in pregnant populations has predominantly focused on the importance of gastric ultrasonography in the presence of gestational diabetes mellitus, this thesis study aims to generate data from the general population. The findings are expected to enable individualized preventive measures to reduce aspiration-related complications during cesarean deliveries performed under general or spinal anesthesia, thereby contributing to patient safety.

Impact of mHealth Education on Hemoglobin Level Among Pregnant Women With Anemia in Rural Bangladesh.

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.

Association of Gestational Cardiovascular Health With Pregnancy Outcomes

Pregnancy is a critical period for cardiovascular health risk assessment and interventions to reduce the incidence of cardiovascular disease in both mother and child generations. Recently, the American Heart Association proposed the latest cardiovascular health assessment indicator "Life's Essential 8". However, there is still a lack of application data for pregnant women. This project intends to explore the application potential of Life's Essential 8 in cardiovascular health assessment of pregnant women and establish appropriate gestaional cardiovascular health standards.

Screening for Intrapartum Fetal Compromise Using Placental Biomarkers

This study aims to investigate the association between placental markers (sFlt-1, PlGF, and the sFlt-1/PlGF ratio) and intrapartum fetal compromise, assessed on the basis of the cardiotocographic tracing.

Impact of UFPs and MNPs on Fetal Health

This project aims at unravelling mechanisms by which exposure to air pollution (in particular Ultrafine Particulate (UFP, PM0.1), and micro nano plastic's) interferes with the normal foetus development, with a short-term causal effect in higher likeliness of preterm delivery which, in consequence, precondition a higher likeliness to suffer non-communicable diseases (NCD) later in the life.

The Effect of Self-Compassion Based Birth Preparation Program

The pregnancy period, during which physiological, psychological and social changes occur, can negatively affect women mentally. It is stated that women's concerns about their own and their baby's health, anxiety and fear regarding birth, the uncertainty of the postpartum process and ambivalent feelings experienced cause negative mood changes. During pregnancy, body image dissatisfaction may develop due to weight gain, posture and skin changes, and this may cause women to experience depressive symptoms. Psychological changes such as depression, anxiety and stress experienced during pregnancy cause women to experience fear and anxiety regarding birth. Fear of birth, which is affected by many factors, also affects women's birth preferences and method. Fear of birth also affects women's psychological well-being in the postpartum period. Interventions are needed to ensure and maintain the psychological resilience of pregnant women. The aim of this study is to determine the effect of a self-compassion-based birth preparation program on self-compassion, body image, fear of birth, depression, anxiety and stress.

National Pregnancy Registry for Psychiatric Medications

The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.

The Effect of Haptonomy Practice on Body Functionality Appreciation and Childbirth Self-Efficacy in Pregnant Women

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

Effectiveness of a Psychosocial Support Intervention for Women Diagnosed With Fetal Anomaly

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.

Development of Post-Disaster Care Protocol for Pregnant Women and Evaluation of Its Effectiveness

It was designed as a randomized controlled experimental study to determine whether the care protocol planned for pregnant women in the disaster area positively affects their physical and psychological health.