Clinical Research Directory

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.

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.

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.

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.

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.

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

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.

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.

PregFit Adventure: Strengthening Mothers-to-Be (PregFit)

1. Design. This will be a randomized clinical trial (RCT) with two groups, an experimental or intervention group and a control group. 2. Population, criteria, sample, calculation. The study population will be low-risk pregnant women. Inclusion criteria: * Pregnant women at low obstetric risk and with no musculoskeletal or health problems affecting their physical condition, ability to exercise or participate in the exergame activities. * Read the information sheet and sign the informed consent form to agree to take part in the study. * \>18 years of age * Spanish comprehension and communication skills * Able to perform physical activity related to the use of the device for at least 30 minutes, 2-3 times a week, for at least 8 weeks Exclusion criteria: * Failure to meet any of the inclusion criteria * Giving birth during the procedure and at least 8 weeks of device use have not elapsed. Assignment: All women receiving maternal education from all participating health centers will be randomized to ensure that there is no sample contamination and their relevance to the intervention or control group will be established according to randomization. Sample size calculation: It was estimated that the number of participants should be at least 15% for this pilot study of what would be a future intervention project. Using self-perceived physical fitness as the dependent variable, and in validation studies having had samples of around 160 women (Romero-Gallardo et al., 2020), at least 24 women will be needed in the single intervention group for this pilot study. Similarly, at least 24 women in the control group are needed for comparison. It is estimated that 20% of women may drop out of the intervention before the minimum 8 weeks, thus establishing a sample size of at least 30 women to recruit. Using similar studies (Tuan et al., 2024) as a reference, we will try to reach the ideal sample size of 42 healthy pregnant women who complete the intervention and at least 42 for the control group who receive routine pregnancy follow-up EpS and antenatal classes. 3. Description of the intervention. * Intervention Group: The program consists of using the device, a minimum of 30 minutes per session two to three times per week and not exceeding ≥3 hours, for at least 8 weeks up to a maximum of 3 months or until the onset of discomfort disabling physical activity, with the minimum time for intervention being at least 8 weeks. Exercise based on exergames will be performed including at least 10 minutes of warm-up and 10 minutes of cool-down, and under the supervision of a licensed health professional. The training program will focus on strength and functional movements. It requires a Nintendo Switch console, a Ring-Con (a Pilates ring that the user holds or ring holder), wireless Joy-Con controllers (the right Joy-Con, connected to the Ring-Con; and the left Joy-Con, attached to the strap around the player's thigh) and a screen. In adventure mode, women will move through the game by performing physical activities such as jogging or doing squats. To minimize risk, knee-assist mode will be used, which makes the game more accessible. Activating knee assist mode provides support when women perform exercises that require walking, kneeling or squatting, making these activities easier for pregnant women, increasing the fitness benefits of the game. In battle mode women will perform aerobic activities, strength training and yoga exercises that involve the whole body to advance in the game. Women will receive in-game coin rewards, character customization and level progression based on exercise volume, which encourages improvement of their skills. As an example, with the assisted knee mode, women will have to squeeze and stretch the titular ring working muscles such as the trapezius, triceps, pectoralis major and minor and abdominal muscles. In addition, to go about defeating the monsters they will have to do shoulder abduction and adduction exercises, internal and external rotation of the shoulders and flexion of the elbow as shown in the images of the orientation trailer, provided to women and available in this memory. @Control Group: Low-risk pregnant women who have normal pregnancy follow-up with Health Education received in childbirth preparation classes and maternal education received in routine pregnancy care by primary and specialized care midwives. Masking: Unique (Results Evaluator). Description of masking: Due to the design of the study and the nature of the interventions, it is impossible to mask staff and participants at the care centers. The evaluators, who measure the outcomes, and the interpreter, who analyzes the data, will be masked in this study. Place: It will take place in a health center, which is part of the ecosystem of the Andalusian Health Service.

Ningbo Maternity-Child Linked Database Study

With the implementation of China's two-child policy and a marked increase in adverse pregnancy outcomes, leveraging electronic health records (EHR) to enhance maternal and child healthcare and outcomes in China has emerged as a novel strategy to tackle this pivotal demographic and health challenge. Given the mature construction of the information platform and the well-established maternal and child health service system in Ningbo, this study utilized the Ningbo Maternal and Child Health Electronic Monitoring Information Management System and the Ningbo Regional Health Information Platform to conduct the Ningbo maternity-child linked database study (MATCHLESS), which involved over 300,000 mother-child pairs in China. MATCHLESS not only allows for longitudinal follow-up of pregnant women and their offspring but also expands its scope from prenatal exposure to long-term outcomes through data linkage. The longitudinal scope of MATCHLESS facilitates the elucidation of the relationship and etiological significance of early-life exposures and adverse pregnancy outcomes. It also permits the exploration of the health trajectory of women and children over their life-course. During the past 5 years (October 2016 to December 2021), a substantial amount of maternal and child health data has been recorded in MATCHLESS, including socio-demographics, health care services and medications, as well as clinical outcome events. 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 was approved by the Ethics Review Committee of the Ningbo University Health Science Center. Considering the safety, privacy, and confidentiality concerns surrounding the storage and processing of personal EHR data, the responsibility for data storage and management is undertaken by the Health Commission of Ningbo. Researchers are required to submit applications to the local health department, and all studies undergo ethical review and research registration procedures to access EHR data for health research purposes.

Comparison in Cervical Length and Prolongation of Gestation Age on Vaginal Progesterone Administration to Pregnant Women After the Acute Phase of Threatened Preterm Birth

This randomised clinical trial aims to investigate the effect of daily vaginal progesterone supplementation on pregnancy prolongation and cervical length changes following arrested preterm labor in singleton pregnancies. The study will recruit pregnant women between 28 and 33 weeks of gestational age who had experienced threatened preterm labor at Dr. Soetomo Hospital in Indonesia. Participants will be randomly divided into two groups: a Treatment Group receiving vaginal progesterone therapy and a Control Group receiving standard care without progesterone intervention. The primary outcomes are the prolongation of gestational age until delivery and the changes in cervical length over time. The secondary outcomes are recurrence of threatened preterm labor, mode of delivery, neonatal outcomes, and survival analysis. This study will provide valuable evidence supporting the use of vaginal progesterone as an effective intervention for women at risk of preterm labor and potentially improving maternal and neonatal outcomes in Indonesia and globally. All participants will be provided with detailed information about the study, and their participation will be voluntary. Ethical considerations, including informed consent and data confidentiality, will be strictly adhered to throughout the study.

Effects of Acupressure Applied Before Cesarean Delivery on Anxiety, Physiological Parameters and Fetal Heart Rate

Cesarean section is the most commonly preferred surgical method in cases where vaginal birth is not possible or complications that may endanger the health of the mother and baby occur. Cesarean section rates are increasing worldwide. According to the latest data (2010-2018) from 154 countries covering 94.5% of live births in the world, 21.1% of women have cesarean section births and it is estimated that this rate will increase to 28.5% by 2030. According to the Centers for Disease Control and Prevention (CDC), the cesarean section rate in the USA, which was 32.1% in 2022, increased to 32.4% in 2023. When the cesarean section rates of the Turkey Demographic Health Survey (TDHS) are examined, the rate, which was 7% in 1993, increased to 52% in 2018, an increase of 45% is observed. In the TRNC, this rate was 11.1% in 1981, but in 2017 this rate increased by an average of 7 times, reaching 72.5%. Pregnant women tend to have cesarean sections because they are affected by the risks that will occur during birth, negative birth stories told among the public, and painful birth scenes seen on social media. Studies have shown that despite the high rates of cesarean sections in pregnant women's birth methods, a significant increase in women's anxiety levels is observed. While waiting for the surgery, pre-operative anxiety, fear of the procedure, etc. are more common than other feelings and symptoms.Studies have also shown that anxiety increases in patient rooms, the night before surgery, and when moving to the operating table. In a study conducted by Lopez, the most important causes of preoperative anxiety were listed as fear of the hospital environment (35%), fear of surgery (33%), fear of anesthesia (45%), and unawareness of the surgery (45%). Concerns about the success of the operation (29.3%), fear of postoperative prognosis (19.5%), and surgical complications (11.4%) are the most common causes of preoperative anxiety. High levels of anxiety experienced before surgery cause increased heart rate, blood pressure, and oxygen consumption during surgery. Controlling and managing preoperative anxiety is one of the most important goals of nursing care worldwide, as in cesarean cases. Mothers need to relax mentally and physically after cesarean sections so that they can care for their babies after birth. A common way to control preoperative anxiety is to use sedatives, but these medications can cause side effects. Therefore, acupressure, which is a non-invasive, low-cost, uncomplicated and non-pharmacological method due to fewer complications, can be used to reduce preoperative anxiety. Acupressure is the application of pressure to stimulate acupoints and meridian lines using an object or fingers, without the use of needles. Acupressure is a simple treatment approach and can be applied by nurses or patients who have received the necessary training, because it is simple and does not require any equipment.