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Pregnancy clinical trials

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NCT ID: NCT03916874 Active, not recruiting - Pregnancy Clinical Trials

The Pregnancy & Early Life Study

PEARL
Start date: May 1, 2019
Phase:
Study type: Observational

The gut is home to a diverse and dynamic microbial community, termed the microbiota. The microbiota is essential for health and wellbeing and is involved in acquisition of nutrients and energy from the diet, optimisation of the immune system, and resistance against invading pathogens. Critically, in both new mothers and their babies, any disturbance of the microbiota (caused, for example, by antibiotics, delivery mode [vaginal/Caesarean section], or dietary change), has the potential to increase the risk that the baby might subsequently develop allergic-type disorders, infections, and chronic intestinal diseases. Early life is a key period of development, but the investigators need a clearer understanding of how maternal factors and transmission of beneficial microbes from mother to baby influence the development of a healthy infant microbiota. This is only possible through longitudinal studies, where the profiles of microbiota from cohorts of mothers and their babies are correlated with routine and more specific clinical data (i.e. antibiotics and diet) throughout pregnancy and into early life. In order to achieve the aims of the study, the Quadram Institute Bioscience (QIB) will work in collaboration with the Norfolk & Norwich University Hospital (NNUH) to recruit 250 pregnant female participants. Study duration will be approximately 31 months and during this time, the investigators will ask the participants to collect urine and stool samples and low vaginal and skin swabs. Blood samples and breast milk are optional. From her newborn, investigators will ask the participant to collect a meconium and stool samples and skin swabs. The participant will complete three different types of questionnaires for herself and her newborn over 31 months. This study is fully funded by the Biotechnology and Biological Sciences Research Council (BBSRC).

NCT ID: NCT03916354 Recruiting - Pregnancy Clinical Trials

Maternal Gestational Weight Gain and Microbiota of Maternal and Infant

Start date: May 7, 2019
Phase:
Study type: Observational [Patient Registry]

A prospective, multicenter, observational cohort study including about 550 mother-infant pairs in Beijing will be conducted to evaluate the association between mothers' gestational weight gain and the gut microbiota of them and their infants.

NCT ID: NCT03900312 Completed - Pregnancy Clinical Trials

Intergenerational Strengths-Based Program for American Indian Girls as They Transition to Adulthood

Start date: November 19, 2018
Phase: N/A
Study type: Interventional

The investigators will conduct a pilot study to assess the acceptability, feasibility, satisfaction, and participant-level outcomes among girls and their mother/female caregiver participating in a preconception health program. The program was developed through an extensive formative phase and is delivered weekly over ~3 months. The investigators will enroll a total of 60 female caregivers and their 8-11 year old daughters/female children to participate in the program and evaluation. Implementation data including acceptability, feasibility and satisfaction will be collected through REDCap and paper assessments completed after each program session and at the completion of the program. Preliminary impact data will be collected through REDCap up to 3 months post-intervention completion. The aims are as follows: 1. To understand if the preconception health program is feasible and acceptable among young girls and their mothers or female caregivers 2. To explore optimal implementation of the program to inform future research and scale up. 3. To assess preliminary impact of the preconception health program on girls' and caregiver's knowledge, cultural connectedness, caregiver-child relationship, community and school connectedness, coping skills, parenting self-efficacy, depression, quality of life as well as substance use behaviors and intentions and intention about sexual activity.

NCT ID: NCT03894228 Recruiting - Pregnancy Clinical Trials

Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)

Start date: May 21, 2019
Phase:
Study type: Observational [Patient Registry]

This is a prospective, observational, multicenter registry, which will enrol pregnant women with IBD (CD, UC, or unclassified IBD) over 5 years in Spain. In addition, each incident gestation will be followed-up during pregnancy, and children born to those mothers will be followed-up over 4 years to determine the incidence of serious adverse events (such as alteration of developmental status, infections, neoplasia or any other serious adverse events) during the study period. In order to harmonize the inclusion of adverse events and complications, only serious adverse events will be registered . The main variable will be the development of serious infection in children as this is the outcome that had controversial results in previous studies.

NCT ID: NCT03893084 Completed - Pregnancy Clinical Trials

Women's Health Behaviors Stages of Change (Transtheoretical Model) in Preconception Period: A Randomized Control Study

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

H0: Preconceptional preparatory training period between pregnancies with and without women is no difference in terms of changes in health behavior. H1: Preconceptional preparatory training period between pregnancies with and without women there is a difference in terms of changes in health behavior.

NCT ID: NCT03888170 Not yet recruiting - Pregnancy Clinical Trials

The Impact of Pregnancy and Pregnancy-associated Hypertension on Human Uterine Myometrial Artery Reactivity

Start date: April 2019
Phase:
Study type: Observational

The investigators seek to describe the composition, architecture, and electrical conduction properties of the human uterine myometrial artery and their impact on vascular reactivity upon exposure to hypertensive stress. Non-pregnant women and pregnant women with and without hypertensive complications will be studied to evaluate the influence of these states on the myometrial arteries. Vascular over-reactivity and disruption of the normal pregnancy-associated physiologic changes of relaxed vascular tone possess the potential for non-compensated blood flow to the uterus and placenta that is insufficient to meet the metabolic demands of a growing placenta. With an understanding of these changes, the research team will be able to propose basic mechanistic changes of pathologic myogenic tone that may ultimately be investigated as potentially modifiable processes to reduce the development and/or severity of these pregnancy complications (gestational hypertension, preeclampsia, eclampsia, small for gestational age, intrauterine growth restriction and intrauterine fetal demise. ).

NCT ID: NCT03879200 Terminated - Pregnancy Clinical Trials

Group Antenatal Care for Somali Born Women

Start date: May 25, 2018
Phase: N/A
Study type: Interventional

Somali-born women comprise one of the largest groups of immigrant women of childbearing age in Sweden, with increased risks for perinatal morbidity and mortality and poor experiences of care. Midwives in antenatal care have expressed a need for development of care tailored for this group of women. The overall aim is to develop and test the acceptability and immediate impacts of group antenatal care for Somali women residing in Sweden, in an effort to improve their experiences of antenatal care, their knowledge about childbearing and the Swedish health care system, their emotional wellbeing and ultimately, their pregnancy outcomes. The study includes four steps: Step I is the preparation phase including needs assessment. Step II is the intervention development and evaluation tool development phase. Step III is the intervention phase, which includes the implementation and evaluation of the intervention using historical controls. Step IV is the process evaluation and "lessons learned". Historical controls (n=80) have received standard individual care according to the national Swedish program for antenatal care, i.e. 8-9 appointments with a midwife during a normal pregnancy. Women in the intervention group (n=80) receive Group Antenatal Care provided in group sessions in a dialogue sensitive to language and cultural issues. The sessions are led by a midwife, assisted by a trained female Somali interpreter. 15 minutes for individual checkups in privacy are provided at end of the session. Primary outcomes: Women's overall ratings of antenatal care and views about specific aspects of care are captured by core questions in the Migrant Friendly Maternity Care Questionnaire (MFMCQ); and emotional wellbeing by the Edinburgh Postnatal Depression Scale (EPDS). Data are collected at recruitment, in gestational week 36 and at 2 months postpartum by means of face-to face interviews or interviews by telephone by a trained bilingual research assistant.

NCT ID: NCT03850600 Active, not recruiting - Pregnancy Clinical Trials

Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease

Start date: January 30, 2019
Phase: N/A
Study type: Interventional

The MELODY Trial: Modulating Early Life Microbiome through Dietary Intervention in Crohn's Disease, will test whether a non-invasive dietary intervention during pregnancy can improve the gut microbiota composition in both pregnant Crohn's disease patients and their babies during the sensitive time window of infant immune system development, and whether this can lead to decreased risk of maternal disease relapse postpartum and decreased functional gastrointestinal disorders and gut inflammation in their babies. Through this trial, the study team hopes to better understand the origin of the initial gut bacterial colonization in babies, providing potential intervention targets to prevent Crohn's disease development in high risk individuals.

NCT ID: NCT03839004 Recruiting - Pregnancy Clinical Trials

MYND&CO: Studio Pilota Dell'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza

MYND&CO
Start date: January 8, 2019
Phase: N/A
Study type: Interventional

To evaluate an integral approach to the maternal-fetal diad. A randomized non farmacological monocentric trial. 400 women with single spontaneous pregnancies are randomized. 200 recieve standardized traditional obstetrical care 200 recieve nutritional advice, osteopathic treatment, yoga classes, mindfulness classes and coaching as well as regular obstetrical care. We evaluate the psychological status at recruitment, at the end of pregnancy and 40 days after birth.

NCT ID: NCT03834909 Withdrawn - Pregnancy Clinical Trials

Pre-Exposure Prophylaxis Dosing in Pregnancy to Optimize HIV Prevention (PREP-P)

Start date: April 2022
Phase: Phase 1
Study type: Interventional

This trial is a prospective, multi-center, randomized comparison study of 2 Pre-Exposure Prophylaxis (PrEP) pharmacokinetic (PK) dosing regimens from 1st trimester through 12 weeks following delivery (postpartum) to achieve study objectives which include PK, safety monitoring for maternal and fetal/infant safety signals, and adherence.