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Pregnancy Early clinical trials

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NCT ID: NCT05870878 Recruiting - Clinical trials for Pregnancy Complications

Generation R Next - Optimaal Opgroeien

Start date: January 19, 2023
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial is to improve birth outcomes and long-term outcomes in mother and child by optimizing lifestyle,nutrition and stress experience in the preconception period and early pregnancy in women and men The main research question that will be addressed is: Does an intervention focused on optimizing preconception and early pregnancy lifestyle, nutrition and stress improve the birth outcomes and long-term outcomes in mother and child? Participants will receive an individual lifestyle consultation at the start of the study. Depending on their study arm, participants will receive an additional lifestyle program focused on health during preconception and early pregnancy, coping with stress and adherence to a healthy(er) lifestyle. The given advices are based on national guidelines. Researchers will compare the intervention group and control group to see if (adherence to) this lifestyle program improve birth outcomes and long-term outcomes in mother and child.

NCT ID: NCT05492981 Active, not recruiting - Down Syndrome Clinical Trials

Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women?

EVA
Start date: July 5, 2021
Phase: N/A
Study type: Interventional

Informed decision-making regarding aneuploidy screening has been reported to be low. Poor knowledge and the lack of deliberation have been cited as reasons for uninformed choices, highlighting the need for adequate pre-test counselling. We conducted a study to assess if an educational video improves informed choice in a clinical setting where both the combined first trimester screen and non-invasive prenatal screening are offered routinely to pregnant women.

NCT ID: NCT05305027 Completed - Pregnancy Early Clinical Trials

Predictive Value of Sequential βHCG in IVF Pregnancy

Start date: January 1, 2011
Phase:
Study type: Observational

Early diagnosis of pregnancy with its localization and evolution has always been one of the major objectives of gynecology and obstetrics, even more so in Artificial Reproductive Technology (ART) centers. The pivotal test is the βHCG assay. Various protocols have been proposed over the years, including single assessment and serial assays. Several studies in the past years have tried to define a cut-off predictive of a successful pregnancy. Abnormal levels of βHCG are associated with biochemical pregnancies, non-viable pregnancies and ectopic pregnancies (EP). The efficacy of a single serum βHCG test to predict EP is low and a significant amount of time and resources are spent diagnosing it. In recent studies, better sensitivity was obtained from the ratio of two successive time points of βHCG concentration, with better specificity instead from regression models. These proposed models however lack validation and require further improvement.

NCT ID: NCT04797338 Recruiting - Miscarriage Clinical Trials

Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders

Start date: December 29, 2017
Phase: Phase 4
Study type: Interventional

Gonadotropin Releasing Hormone agonist (GnRHa) triggering is used as an alternative to human chorionic gonadotropin (hCG) in GnRH antagonist protocol to eliminate the risk of ovarian hyperstimulation syndrome (OHSS). However, its main disadvantage is a significantly lower pregnancy rate, hypothesized to result from a process called "luteolysis" (demise of the corpora lutea). In order to preserve a high pregnancy rates, several luteal support regimens were investigated, including an intensive estrogen and progesterone supplementation and a daily GnRHa treatment. However, no study, so far, compared the efficacy of these two regimens. Our aim is to compare the efficacy of GnRHa versus estrogen and progesterone supplementation for luteal phase support in high responders following GnRHa triggering.

NCT ID: NCT04714905 Completed - Pregnancy Related Clinical Trials

Better Understanding the Metamorphosis of Pregnancy (BUMP)

BUMP
Start date: February 23, 2021
Phase:
Study type: Observational [Patient Registry]

Pregnancy is a commonly occurring medical event. Women who are pregnant may experience pregnancy-related symptoms and complications. However, there is a relative lack of multi-dimensional data on large populations of pregnant patients. The Study Investigators aim to derive novel insights and deeper understanding of maternal physiology and pathology through the analysis of an unprecedented breadth and depth of data collected from connected devices (i.e., wearables, smart home scale, mobile apps, etc.), additional virtual study assessments and support calls, and information derived from standard of care clinical visits. They will share these insights to empower patients to better care for themselves. The Investigators hope to know how leveraging the data collected from connected devices in addition to information obtained from routine clinical care helps researchers and clinicians better understand pregnancy related symptoms, conditions, and complications.

NCT ID: NCT04565873 Completed - Pregnancy Related Clinical Trials

Thyroid Stimulating Hormone (TSH) Level Variations in Early Pregnancy

Start date: January 1, 2014
Phase:
Study type: Observational

Retrospective comparative study comparing group 1 (TSH level 0.1-1.99 mIU/L) and group 2 (TSH level 2.0-4 mIU/L). Each group was further subdivided into primigravidae and multipara. 1527 pregnant women were included.

NCT ID: NCT04454749 Terminated - Infertility, Female Clinical Trials

Endometrial Compaction and Its Influence on Pregnancy Rate in Frozen Embryo Cycle Regimes

Start date: November 9, 2020
Phase:
Study type: Observational

For a pregnancy to occur, an euploid embryo at blastocyst developmental stage, a receptive endometrium and the synchrony of both is crucial. Many studies lately investigated the influence of the endometrial thickness and pattern on the artificial reproductive technology (ART) outcome, however, with conflicting results.

NCT ID: NCT04321564 Completed - Depression Clinical Trials

Comparison of Beck Depression Score in Multipar and Nulliparous Women Who Have Gone Under Dilatation and Curettage

Start date: January 20, 2019
Phase:
Study type: Observational

It is aimed to compare the beck depression and anxiety values of the nulliparous and multipar pregnant women who undergo optional abortion below 12 weeks and to evaluate the effect of the parity on depression and anxiety.

NCT ID: NCT04182750 Completed - Clinical trials for Medication Adherence

Promoting Safe Medication Use in Pregnancy in the Era of Real-World Data - The SafeStart Study

SafeStart
Start date: February 6, 2018
Phase: N/A
Study type: Interventional

The background for this project is the growing concern about women's use of medications during pregnancy. Several studies have shown that up to 80% of all pregnant women use at least one medication during pregnancy, most commonly prescription-free medications for pregnancy-related ailments. Despite the frequent use of medications during pregnancy pregnant women tend to overestimate the teratogenic risk of medications - often resulting in unfound anxiety, non-adherence to needed medication, use of herbal "natural" medications, and in the worst case, termination of otherwise wanted pregnancies. Specifically, the investigators have found that ailments such as nausea and vomiting in pregnancy (NVP), often are mismanaged, resulting in profound impacts on the women´s quality of life, but are often being neglected by healthcare personnel. The objective of this project is to investigate whether a pharmacist consultation provided in early pregnancy can result in optimized management of pregnancy-related ailment, a higher quality of life and reduce sick leave among pregnant women. The investigators will capitalize on the existence of a unique personal identification number allocated to every citizen in Norway and link the self-reported data generated in the intervention study to five national health registries. As even mild NVP has been shown to have a huge impact on pregnant women's quality of life, the investigators will specifically focus on preventative measures for NVP. The investigators main hypothesis is: "A pharmacist intervention focusing on safe medication use and in early pregnancy can reduce sick leave days and rates, enhance adherence, promote better management of common pregnancy-related ailments (especially NVP), and improve pregnant women's quality of life" The investigators will include all pregnant women in pregnancy weeks <12. Pregnant women under the age of 18, women who do not understand Norwegian and women for some other reason are unable to sign the consent form will be excluded. Women eligible for inclusion will be allocated to either the intervention group or the control group. Participants in the intervention group will be directed to the nearest study pharmacy for the intervention. The proposed study intervention is to be applied and carried out in the community pharmacy. Approximately 10-15 community pharmacists across the country will be involved. If the distance to a study pharmacy is too far for a physical meeting, the intervention will be performed over the telephone; otherwise, the private information room in the pharmacies will be utilized. All pharmacists involved in the study will be specifically trained to perform the consultation. They will complete several e-learning modules on pharmacotherapy in pregnancy and attend a full-day training work-shop focusing on communication skills led by experienced clinical pharmacists. Data will be collected by four online questionnaires, one at baseline in the first trimester, one during the second trimester, one during the third trimester, and the last one in the post-partum period. Participants in the intervention group will, in addition, complete a satisfaction questionnaire right after the completion of the consultation. All questionnaires will be distributed to the participants by email. Data about the participants will, in addition, be collected from five national registries; National Sick Leave Database (Forløpsdatabasen Trygd), The Norwegian Patient Registry, The Norwegian Prescription Database, The Medical Birth Registry of Norway, and the Municipality Patient and User Registry (Kommunalt Bruker- og Pasientregister). These data will be linked to the self-reported data (by the unique identification number of every citizen in Norway) collected during the intervention study. An economic evaluation will be done to assess the cost-effectiveness of the intervention. All study pharmacists involved in the study will be invited to participate in a qualitative interview to share their experience and opinions regarding the pharmacist intervention. Participants enrolled in the intervention study will be invited to a qualitative interview to share their inputs and opinions on what a mobile application for self-management and an online patient-centered decision support tool for NVP should include.

NCT ID: NCT03957200 Completed - Pregnancy Early Clinical Trials

Assessing Gestational Age in First Trimester Pregnancies Using Ultrasound

Start date: June 18, 2019
Phase:
Study type: Observational

The objective of this study is to assess equivalency of the transabdominal Clarius handheld wifi C3 ultrasound (which uses Bluetooth to locate the ipad Mini 5 and then uses wifi direct to show the images) to the current standard of care in Women's Hospital outpatient department the portable Zonare ZS3 in patients presenting in the first trimester of pregnancy.