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Pregnancy Related clinical trials

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NCT ID: NCT06297005 Recruiting - Pregnancy Related Clinical Trials

The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study

ECHO
Start date: October 9, 2023
Phase:
Study type: Observational

Tobacco smoking in pregnancy is now widely accepted as having adverse health outcomes for both the mother and fetus. Tobacco smoking in pregnancy is associated with increased incidence of miscarriage, stillbirth and preterm birth as well as low birthweight, respiratory infections, wheeze and asthma in childhood. E-cigarettes are a popular method for trying to quit smoking in Ireland and there has been an explosion in the use of e-cigarettes over the past ten years. However, there is currently insufficient evidence on their long-term safety and effectiveness as a smoking cessation tool. E-cigarettes contain varying combinations of compounds and flavours which are used differently in different e-cigarette types, with unknown long-term effects. Research has shown that pregnant women perceive e-cigarettes to be a healthier option when compared with tobacco smoking. But, there is very little known about the long-term health impact of exposure of unborn babies to e-cigarettes during pregnancy. The ECHO study will determine what the long-term health outcomes are in children born to mothers who use e-cigarettes during pregnancy. Specifically, we will focus on birth, nutritional, brain development and respiratory outcomes in children. To answer this research question, the ECHO study will recruit infants born to women who use e-cigarettes during pregnancy across three maternity hospitals and follow them up over 2 years. We will invite women at their booking visit to take part in this research study. We plan to also recruit a similar number of both non-smoking and tobacco smoking pregnant women for comparison. We will record a detailed record of e-cigarette and tobacco use by women during pregnancy as well as checking smoking using special monitoring tools. After the baby is born, we will perform growth measurements, neurocognitive assessments and a respiratory questionnaire at 6 months, one year and two years of age.

NCT ID: NCT06288126 Completed - Pregnancy Related Clinical Trials

Maternal and Fetal Metabolic Changes

MoMM-FET
Start date: August 1, 2019
Phase:
Study type: Observational

The goal of this observational prospective project is to study the metabolic alterations during normal and complicated pregnancies, obtaining an early detection of metabolic changes, offering new insights into future prevention and treatment strategies for both mother and offspring. Primary objectives: - measurement of maternal blood adipokine levels, during the first trimester of pregnancy, in two groups of women (high and low risk), in order to identify early markers which, in conjunction with the medical history, can identify women at increased risk of developing GDM - ultrasound measurement of adipose tissue deposits at ectopic sites, comparing low- and high-risk women, and assessing the effect of pregnancy on these deposits. - Identification, by targeted ultrasound assessment, of fetuses at increased risk of macrosomia. Secondary objectives: - Evaluation of the prevalence of GDM and its complications in a population of low- and high-risk women. - Evaluation of neonatal complications in children born to low- and high-risk mothers (need for resuscitation, hypoglycaemia, hypocalcaemia, admission to neonatal intensive care unit). The participants will be recruited during first trimester ultrasound after signing the informed consent.

NCT ID: NCT06284278 Recruiting - Pregnancy Related Clinical Trials

Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain

Start date: October 20, 2023
Phase: N/A
Study type: Interventional

The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain.

NCT ID: NCT06273683 Recruiting - Pregnancy Related Clinical Trials

Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery

Start date: March 11, 2024
Phase:
Study type: Observational

One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide. A preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes.

NCT ID: NCT06272721 Not yet recruiting - Pregnancy Related Clinical Trials

Hypothyroidism in Pregnancy and Neuropsychological Development in Children

OHPLDO
Start date: February 19, 2024
Phase: N/A
Study type: Interventional

Thyroid dysfunction, particularly hypothyroidism and thyroid autoimmunity, impacts a significant proportion of pregnant women, affecting 3% and 17% respectively. The management of thyroid-stimulating hormone (TSH) levels is crucial, with subclinical hypothyroidism often defined by a TSH upper reference limit of 4 mU/L, and overt hypothyroidism by TSH levels above 10 mU/L and potentially low free thyroxine (FT4) levels. Levothyroxine (LT4) treatment is strongly advised for TSH levels above 10 mU/L, with the timing of intervention being critical during the first trimester for optimal fetal brain development. Research shows that untreated maternal hypothyroidism can significantly impact the neuropsychological development of the child, affecting cognitive, verbal, and motor skills. Even subclinical maternal hypothyroidism has been associated with lower IQ and motor scores in children. Early pregnancy intervention is key, as treatment after the first trimester may not improve children's neurocognitive outcomes. Regarding sensory and linguistic development, evidence is mixed, but recent studies suggest that maternal hypothyroidism can lead to expressive language delays. The Development Quotient (DQ) is used to assess cognitive and motor development in children, with the Griffiths Mental Development Scales II being a common tool. This study aims to explore the effects of treated maternal hypothyroidism during pregnancy on children's neurodevelopment, focusing on learning and language. It includes 31 women diagnosed with hypothyroidism and a control group of 21 euthyroid women, along with their children. The study emphasizes the importance of early detection and treatment of maternal hypothyroidism for preventing adverse neurodevelopmental outcomes in offspring. Statistical analysis will be conducted using SPSS, with a focus on maternal-fetal outcomes and cognitive-neuropsychological outcomes, highlighting the significance of early intervention.

NCT ID: NCT06268353 Not yet recruiting - Pregnancy Related Clinical Trials

Is the Plasma Concentration of CAPGDF15 Increased in Pregnancy? A Pilot Study

CAP
Start date: March 15, 2024
Phase: N/A
Study type: Interventional

Background and Purpose During pregnancy, the hormone GDF15 rises between 100-200 times higher than before pregnancy. The significance of this dramatic increase is not clarified, but it has been shown that pregnant women with insufficient increase in GDF15 have a higher risk of spontaneous abortion. CAPGDF15 is a small peptide consisting of 12 amino acids recently found in plasma in both mice and humans, and this peptide is part of the prohormone from which GDF15 is synthesized. Therefore, the assumption is that CAPGDF15 is secreted simultaneously with GDF15. The significance of CAPGDF15 in the organism is completely unknown, except that injection into mice reduces food intake. Therefore, the investigators are interested in investigating whether there is a similar dramatic upregulation of CAPGDF15 as with GDF15 itself. The investigators will not set up a large-scale study without having some prior knowledge of whether this is indeed the case. Therefore, the investigators will conduct a pilot study on 3 pregnant women and 3 control women to examine whether there is any reason to proceed with an actual scientific experiment. Since the increase in GDF15 itself is very large at least100 fold, a pilot study involving only 3 pregnant women and 3 non-pregnant women will be sufficient to gain an impression of whether there is also a significant increase in CAPGDF15. The data will be used to assess whether an actual research project is worth establishing. Purpose: The purpose of conducting this pilot study is to investigate whether there is an upregulation of CAPGDF15 similar to that of the hormone GDF15 during pregnancy. By conducting a pilot study on 3 pregnant women and 3 control women, the investigators will see if this is actually the case before setting up an actual scientific experiment.

NCT ID: NCT06262347 Not yet recruiting - Pregnancy Related Clinical Trials

Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD

TOME
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons.

NCT ID: NCT06259669 Recruiting - Atopic Dermatitis Clinical Trials

Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population

OPERA-1
Start date: September 13, 2023
Phase:
Study type: Observational

This observational (enrollment into the registry while the pregnancy is ongoing) study is being conducted to compare the frequency of major congenital malformation (MCM)s among infants of women exposed to ruxolitinib cream during pregnancy with infants of women not exposed to ruxolitinib cream during pregnancy.

NCT ID: NCT06258902 Recruiting - Pregnancy Related Clinical Trials

Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation

Start date: September 28, 2023
Phase:
Study type: Observational [Patient Registry]

The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first. This study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participants, the healthcare providers (HCP) involved in their care or the care of their infants, if applicable, and Albireo pharmacovigilance. Study start date is either start of data collection or first patient enrolled whatever occurs earlier. The surveillance program is strictly observational; the schedule of office visits and all treatment regimens are determined by HCPs. Only data that are routinely documented in patients' medical records as part of usual care will be collected. No additional laboratory tests or HCP assessments will be required as part of this surveillance program.

NCT ID: NCT06257186 Recruiting - Anxiety Clinical Trials

Investigating the Effect of Art Therapy on Women With Fear of Childbirth During Pregnancy: A Mixed Method Study

Start date: November 2, 2023
Phase: N/A
Study type: Interventional

Childbirth is a multifaceted experience and could involve both positive and negative feelings. Feelings of limited capability in the face of childbirth may result in a condition termed as Fear of Childbirth (FOC), which contributes to significantly higher risks of birth complications resulting in psychological trauma. This study aims to examine the effects of Art Therapy (AT) on FOC, perceived maternal parental self-efficacy, postpartum maternal infant bonding and postpartum depression. A mixed-methods sequential explanatory design will be used. Phase one will adopt a quasi-experimental study design. Women who are aged 21 and above, English literate and having a singleton pregnancy will be approached to fill in the Fear of Birth Scale (FOBS). Participants with FOBS score of 60 and above will be considered as having FOC and will be invited to participate in the AT intervention. Participants who are agreeable to receive AT will be recruited in the experimental group. Participants who declined to participate in AT will receive routine antenatal care (control group). Outcomes that will be measured in both groups include perceived maternal self-efficacy, maternal infant bonding, and maternal depression after childbirth. A qualitative descriptive design will be used in phase two. Semi-structured interviews will be conducted with the participants to explore their experiences of the AT. Descriptive analysis, independent sample t-test, paired sample t-test, and regression analysis will be used for analysis of the quantitative data in phase one. Qualitative data from phase two will be analysed using thematic analysis. Findings of this study may provide evidence on the use of AT to cope with FOC during pregnancy. If proven to be beneficial, AT may potentially be introduced and advocated as an intervention for women with FOC.