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Pregnancy clinical trials

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NCT ID: NCT06001450 Recruiting - Pregnancy Clinical Trials

Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation

PLANET
Start date: August 30, 2023
Phase:
Study type: Observational

The PLANET Study aims to determine the impact of microplastics on intestinal inflammation and gut microbiome in order to understand the role of this pollutant on the risk of developing inflammatory bowel disease (IBD) as well as other diseases. With this information, the researchers hope to characterize better the role of environmental pollutants on IBD and develop novel strategies towards prevention.

NCT ID: NCT05973552 Recruiting - Pregnancy Clinical Trials

Iron Absorption and Requirements in Pregnancy and Lactation

PILLAR_II
Start date: July 31, 2023
Phase:
Study type: Observational

Iron requirements increase significantly during pregnancy. Current recommendations for iron intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and extrapolated from non-PLW. High-quality quantitative data on iron requirements in PLW are lacking, particularly in Sub- Saharan Africa where anaemia and infections are common. The primary objective of this study is to use the stable iron isotope technique to determine iron requirements and assess iron absorption and losses in PLW living in Kenya. In this prospective observational study, we will enrol pregnant women in the first trimester (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now distributed and equilibrated throughout the women's body iron. Once enrolled in the present study, following Kenyan guidelines, women will receive standard prenatal care, including routine daily iron and folate supplementation. We will collect venous blood samples in each trimester and at delivery, and during the first 6 months of lactation in the mothers and infants (heel prick samples). To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered in the 2nd and 3rd trimesters.

NCT ID: NCT05946447 Completed - Pregnancy Clinical Trials

Intra- and Interrater Reliability of Quantitative Ultrasound Assessment of Gastric Content in Term Parturients Before Elective Caesarean Delivery

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

The presence of solid food or fluid residue in the stomach is always a major concern when patients require medical procedures under sedation or general anesthesia, due to the high risk of pulmonary aspiration of the stomach contents. This is especially important in emergency procedures, when a fasting period could not be observed. Pulmonary aspiration of gastric content is a serious perioperative complication of obstetric anesthesia, and it is associated with morbidity and mortality. Information from a bedside ultrasound assessment of the stomach may be a very useful resource to decide whether it's safe to proceed, cancel or delay a surgical procedure. The ultrasound assessment of the stomach content has shown to be very feasible and practical in non-pregnant patients. However, it has not been determined whether the competence reached by anesthesiologists in non-pregnant subjects can be transferred to the obstetric population, especially in term pregnant patients where it could be difficult to identify the stomach because of the presence of the gravid uterus. Although quantitative assessment of the gastric antrum cross-sectional area in terms of intra- and interrater reliability has been evaluated in non-pregnant adults, it remains to be evaluated in pregnant patients. Furthermore, it has not been determined whether the performance of novice operators is comparable to expert operators in the gastric quantitative assessment. This study aims to determine whether trained anesthesiologists can reliably assess the stomach content of pregnant patients by ultrasound, evaluating the inter- and intra-rater reliability of quantitative gastric ultrasound in term pregnant patients comparing anesthesiologists of different level of expertise. The investigators hypothesize a substantial to almost perfect agreement in the intra- and interrater reliability of the antral cross-sectional area among raters in term pregnant patients scheduled for elective cesarean delivery.

NCT ID: NCT05940688 Recruiting - Pregnancy Clinical Trials

Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study

P?OPPY
Start date: July 17, 2023
Phase: N/A
Study type: Interventional

The P3OPPY Project is one of five projects within the American Heart Association P3 EQUATE Network. The overarching goal of the P3 EQUATE American Heart Association Health Equity Research Network (HERN) is to promote equity in Maternal and Infant Health outcomes by identifying innovative and cost-effective strategies to enhance access to quality health information, care, and experiences during pregnancy, postnatal and postpartum/preconception periods, particularly for Black and under-served populations. Collectively, the investigators will collaborate with pregnant and postpartum individuals and their families, hospitals, and communities to discover ways to reduce racism and social problems that contribute to poor health outcomes.

NCT ID: NCT05934318 Not yet recruiting - Pregnancy Clinical Trials

L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)

AGREE
Start date: September 30, 2023
Phase: N/A
Study type: Interventional

There are few safe, effective, and affordable interventions to improve pregnancy outcomes in low resource settings where the highest rates of poor birth outcomes occur. L-citrulline is naturally found in many foods and is changed into another important amino acid, L-arginine, in the body. L-arginine is important for the growth of a healthy placenta and healthy baby. Adding L-citrulline to the diets of pregnant women may be an effective and affordable way to improve the health of their babies.The goal of the AGREE trial is to test whether a dietary supplement containing a common food component, an amino acid called L-citrulline, can help pregnant Kenyan women at risk of malaria have healthier pregnancies and healthier babies. 2,960 pregnant Kenyan women will be enrolled and randomly assigned to take either a twice daily dietary supplement containing L-citrulline or a placebo supplement without additional L-citrulline. Maternal participants will be seen every month until delivery and at weeks 1 and 6 after birth. Infants will also be followed up at ages 6, 12, 18, and 24 months. The primary outcome of the study is 'adverse pregnancy outcome', a composite of foetal loss (miscarriage or still birth), preterm birth, low birth weight, small for gestational age or neonatal mortality. The results of the AGREE trial could help to guide obstetric and public health policy and provide a sustainable solution that could be implemented at the community level.

NCT ID: NCT05929963 Enrolling by invitation - Pregnancy Clinical Trials

Observational Study of the Interaction Between Hepatitis C Virus Infection and Pregnancy

Start date: May 9, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about he effects of hepatitis C virus on pregnancy. The main question[s] it aims to answer are: Effect of hepatitis C virus on liver function in pregnant women Mother-to-child transmission rate in pregnant women with hepatitis C

NCT ID: NCT05929586 Not yet recruiting - Pregnancy Clinical Trials

Digital Data Linkage and Scheduling to Track Pregnancy With or Without Community Data Use to Increase Antenatal Clinic Uptake in Western Kenya.

C-it-DU-it
Start date: October 2023
Phase: N/A
Study type: Interventional

The investigators propose to increase ANC uptake through a health systems strengthening approach that links digital data platforms and trains community Work Improvement Teams (WITs) to use these data to identify problems and come up with local solutions. Our short name C-it DU-it (pronounced "see-it; do-it") is an acronym intended to convey 'seeing' linked data (C-it) and 'doing' or acting on the data (DU-it). The trial design is a 2-arm, cluster-randomised controlled superiority trial in Homa Bay County to determine the efficacy of 'C-it DU-it' intervention (data use arm) to increase ANC contacts when compared to the 'C-it' enhanced standard of care (control arm).

NCT ID: NCT05928117 Completed - Pregnancy Clinical Trials

Training Given in the Line of Coping With Fear of Birth on Fear of Birth Birth Experience

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Pregnancy and childbirth are a natural life event for women, as well as a process in which physical, biological and psychosocial changes are experienced. This process causes women to perceive childbirth as an unknown and unpredictable situation, resulting in the fear of childbirth. Due to the fear of childbirth, the daily routines, professional lives, social activities and relationships of pregnant women are significantly affected. This study was planned to evaluate the effect of mobile education given in line with the "Guide to Coping with Fear of Birth" on fear of birth, birth preference and maternal satisfaction at birth. Research; It will be carried out at the T. C. Ministry of Health Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital. Data; The first one is 28-30th of pregnancy. week, the second is 36-38. It will meet in three meetings in total, the third of which will be within 12-24 hours postpartum. Data, Personal Information Form (Annex-1), Wijma Birth Expectation/Experience Scale (W-DEQ) Version A (Annex-2), Wijma Birth Expectation/Experience Scale Version B (Annex-3) and Birth Experience Scale ( Annex-4) and Postpartum Questionnaire (Annex-5). The obtained data will be analyzed with the SPSS 22.0 program. In this study, it is thought that the training given to women with a high level of birth fear can reduce their fear of childbirth and increase maternal satisfaction at birth.

NCT ID: NCT05910580 Not yet recruiting - Pregnancy Clinical Trials

Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years

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

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: - Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? - Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? - Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person SBIRT, telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

NCT ID: NCT05904925 Not yet recruiting - Pregnancy Clinical Trials

Pilates for the Prevention of Musculoskeletal Complaints During Pregnancy

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot randomized controlled trial with economic evaluation is to evaluate the viability of Pilates in the prevention of musculoskeletal complaints, throughout the entire gestational period, in pregnant women. The main question it aims to answer is if it is feasible to perform exercises during the entire gestational period to prevent musculoskeletal disorders. Participants will be assessed primarily for acceptability, suitability, feasibility, and fidelity, and secondarily for the occurrence of musculoskeletal complaint and the number of days from randomization on which this musculoskeletal complaint occurred, type of delivery and costs. Then, participants will be randomized into two groups: the usual care group, which will receive an educational booklet with information about the usual care during pregnancy, and the Pilates group, which will receive the same educational booklet and will participate in a specific Pilates exercise program for the gestational period, twice a week, throughout the pregnancy.