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Pregnancy Related clinical trials

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NCT ID: NCT04016428 Completed - Depression Clinical Trials

Online Prenatal Trial in Mindfulness Sleep Management

OPTIMISM
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to assess an online mindfulness intervention for pregnant women (6 weeks) for the treatment of insomnia and prevention of depression relapse in pregnancy. This mindfulness intervention will also be compared with an online intervention (6 weeks) consisting only of education about insomnia in pregnancy. The principal hypothesis is that the mindfulness intervention will be more effective than the education-only intervention.

NCT ID: NCT04009395 Completed - Pregnancy Related Clinical Trials

Barriers and Facilitators to the Uptake of Healthy Eating Messages

Start date: October 29, 2020
Phase:
Study type: Observational

Obesity is on the increase and black Africans in the United Kingdom (UK) make up a significant part of this population (32%). Weight retention after pregnancy is considered as one of the leading causes of obesity. African women living in high-income countries have been found to experience more weight retention after pregnancy than Caucasian women. Healthy eating guidelines have been provided in pregnancy in the UK (National Institute for Health and Care Excellence) and midwives have been placed to provide healthy eating advice in pregnancy, but some studies have identified that African migrants in the UK often eat and prepare food in a different way to the traditional British approach. It has also been observed that the recommended advice for pregnant women, for example, the Eat well plate and start4life are focused on traditional British foods and cooking patterns and do not include food that would be familiar to African migrants. This may impact on the meaningfulness of such guidance to African women. Therefore, this research aims to understand what prevents healthy eating or makes healthy eating easier for pregnant African migrant women in the UK. This would include understanding how healthy eating is interpreted, the cultural factors that are considered important in healthy eating, the current sources of nutrition information and midwives view on providing healthy eating advice to this population. Eligibility - Pregnant African migrant women (18 and above) attending ante-natal clinics in NHS hospital sites. - Midwives who provide ante-natal advice to pregnant Africans Where Study sites will be hospitals covered by the Epsom and St Helier University trust, London North West University Healthcare National Health Service (NHS) trust and the Lewisham & Greenwich NHS trusts. How: The study will involve one-on-one interviewing with pregnant women and midwives using hospital spaces provided by the hospital. Focus group discussions with midwives will be attempted depending on logistics. The interviews are expected to last about one hour to one and a half hours. Interview sessions will be audio-taped with the permission of the participants. Data collection is expected to last for 6 months.

NCT ID: NCT03969498 Completed - Cancer Clinical Trials

Evaluation of the Incidence of Cancer in the Follow-up of Women With 3 Consecutive Embryonic Demises Before 10 Weeks or 1 Fetal Death, According to Their Thrombophilia Status, With a Special Focus on Women With an Obstetric Antiphospholipid Symdrome (oAPS)

NOHA-K
Start date: January 2, 2018
Phase:
Study type: Observational

A number of case reports describe the association of antiphospholipid antibodies (aPL Abs) with hematological and solid organ malignancies. Especially in elderly patients, thrombotic events associated with aPL Abs can be the first manifestation of malignancy. Cancer-associated monoclonal gammopathy of the IgM type can be accompanied by positive lupus anticoagulant (LA) or an anticardiolipin (aCL) IgM. Cancer and antiphospholipid antibody syndrome (APS) can coexist in sporadic cases, while some cancer patients with or without thrombosis may show some transitory aPL Ab positivity, the most striking symptomatic clinical feature, catastrophic APS, being even described in cancer patients. Some reports suggest a significant incidence of malignancies in APS patients. Cancer was the 2nd cause of death (13.9%), after bacterial infection, during the 10-year follow-up of the 1,000 APS patients studied by the Euro-Phospholipid Project Group, but no control group was simultaneously evaluated. The risk of cancer in patients with APS is thus still uncertain. The Nîmes Obstetricians and Haematologists APS (NOH-APS) study was based on the recruitment of a cohort of women with no history of thrombosis, who had experienced pregnancy loss fulfilling the clinical criteria of obstetrical APS (oAPS), who were either positive for aPL Abs (APS group), or positive for the F5 rs6025 or F2 rs1799963 polymorphism (Thrombophilia group), or negative for thrombophilia screening (Control group). We now want to assess the comparative incidence of cancer in women for whom an oAPS diagnosis had been made. This evaluation will be carried out during the 2017 medical follow-up step, corresponding to a median follow-up of 17 years. An external, local population-derived control group, the registry of tumors in Montpellier area (Registre des Tumeurs de l'Hérault) will be used to compute standardized incidence ratios (SIRs).

NCT ID: NCT03954418 Completed - Diabetes Clinical Trials

Transport of Artificial Sweeteners During Pregnancy

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

With obesity on the rise worldwide more and more young women are also affected, leading to a higher prevalence of obese pregnant women and pregnant women with diabetes. Children of these women are in risk of developing obesity during childhood which again leads to overweight during adult life resulting in life-style related diseases such as diabetes and cardio-vascular disease. Overweight and diabetic women are currently advised to substitute sugar sweetened beverages with artificially sweetened beverages to lower caloric intake and avoid fluctuations in blood glucose to avoid complications during pregnancy for both mother and child. Recent studies suggest that high intake of artificial sweeteners during pregnancy increases the risk of the child developing obesity. If this is indeed true, the current guidelines have the opposite of the wanted and children already in risk of overweight are exposed to extra risk. To investigate if artificial sweeteners can affect the foetus, the investigators wish to examine whether artificial sweeteners can cross the placenta. The study is a clinical trial in which 40 women will be enrolled. 30 participants will drink a diet soft drink 2 hours before a caesarean section and 10 controls will refrain from intake. After birth the investigators will obtain a blood sample from the mother and from the umbilical cord and a placental biopsy and measure the contents of artificial sweeteners. Furthermore, the investigators will obtain a sample of amniotic fluid to examine if the sweeteners are excreted into the amniotic fluid. The results ultimately have the potential to change the current guidelines on diet for overweight and diabetic women during pregnancy.

NCT ID: NCT03951649 Completed - Pregnancy Related Clinical Trials

Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine

Start date: February 10, 2020
Phase: Phase 4
Study type: Interventional

This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.

NCT ID: NCT03950167 Completed - Pregnancy Related Clinical Trials

Gallbladder Functions & Serum Cholecystokinin Levels in Women Diagnosed With Hyperemesis Gravidarum

Start date: March 26, 2019
Phase:
Study type: Observational

This study evaluates the gallbladder functions and serum cholecystokinin levels in pregnant women diagnosed with hyperemesis gravidarum. Half of the participants are healthy pregnant women and half of the participants are pregnant women diagnosed with hyperemesis gravidarum. Two groups will be compared by means of gallbladder functions and serum cholecystokinin levels.

NCT ID: NCT03938129 Completed - Pregnancy Related Clinical Trials

Improving Women's and Children's Health Via Biobanking and Electronic Registry

iELEVATE
Start date: January 7, 2020
Phase:
Study type: Observational

Pregnancy related diseases and exposures in pregnancy are known risk factors for future disease. For example, women with a history of preeclampsia (a hypertensive disorder in pregnancy) and children born to these women are at increased risk of cardiovascular disease later in life. Yet, the mechanisms by which these long term health risks occur are unknown. Clearly, this presents a significant public health hazard as preventative and therapeutic interventions to block these pregnancy related diseases are limited. Current barriers to studying these long-term mechanisms in existing cohorts include 1) lack of paired long-term mother-child data, 2) lack of uniformly collected biosamples and 3) challenges in integrating data from multiple sources and institutions. In particular, data and biosample collection from rural and minority populations present significant challenges. The objective of the iELEVATE proposal is to expand and diversify a current biobank to accelerate long-term translational mechanistic and outcomes research in the vulnerable pregnancy population. We will accomplish this by establishing a widely available biorepository that will collect a first trimester blood and urine sample from pregnant women with a clinical data warehouse and e-registry to support long-term prospective cohort studies.

NCT ID: NCT03913104 Completed - Pregnancy Related Clinical Trials

Mail Order Mifepristone Study

Start date: January 5, 2020
Phase: Phase 4
Study type: Interventional

This study aims to evaluate the feasibility, acceptability, and effectiveness of dispensing mifepristone via a mail-order pharmacy. The investigators will recruit patients at up to 10 primary care and internal medicines sites not currently providing abortion services around the country, as well as abortion clinic sites. Patients will go through routine in clinic visits to determine eligibility and then will receive the medications in the mail at their preferred address. The investigators will survey patients 3 and 14 days after the initial clinic visit and interview providers at the end of the study.

NCT ID: NCT03855735 Completed - Pregnancy Related Clinical Trials

TeamBaby - Safe, Digitally Supported Communication in Obstetrics and Gynecology

TeamBaby
Start date: September 2, 2019
Phase: N/A
Study type: Interventional

The purpose of this project with obstetric healthcare workers, pregnant women and their relatives is to improve communication between all parties involved in order to increase sustainable patient safety. To this end, clinical staff, expectant mothers and their partners as well as relatives will be trained in personal sessions and through digital interventions. The aim is to improve their ability to communicate more confidently with each other. In addition, an app will be developed to support all participants in their communication with each other and in overcoming difficulties in everyday hospital life. The project contributes to reduce the frequency of preventable adverse events (pAEs) in gynecology and obstetrics and to increase patients' satisfaction with their treatment. Data will be collected in three study phases: 1. Implementation phase - Training for obstetric healthcare workers at two German university hospitals which will be developed and implemented based on observations, interviews, and focus groups and pre-experimental study with pre/post-test (questionnaires for participants, interviews). To evaluate patient safety, an analysis of hospital data will be conducted incl. retrospective cohort study; 2. Effectiveness study with randomized controlled study design (questionnaires and interviews). In the intervention group, pregnant women and their relatives will be trained in safe communication; 3. Implementation of an app (evaluated via questionnaires, observations, interviews, focus groups). Women who receive the training via the app will be compared to the historical control group as case-control study (questionnaires, interviews, analysis of hospital data).

NCT ID: NCT03854331 Completed - Stress Clinical Trials

OBEAT - Beating Obesity

Start date: June 18, 2019
Phase: N/A
Study type: Interventional

The primary objective of this trial is to study the feasibility of a resilience intervention to reduce stress and thus improve sleep, healthy diet and physical activity in normal weight pregnant women. Initially, an exploratory study of stressors and worrying in pregnant women will be done by use of qualitative methods (focus group interviews) followed by a randomised controlled feasibility trial with a parallel qualitative process evaluation. This project is expected to improve the understanding of the processes and feasibility of conducting a randomized intervention study to examine if improvements in chronic stress and poor sleep during pregnancy improves early weight gain and childhood risk of obesity.