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195 active trials for Pregnancy Related

Realization of Sequencing of All Known Human Genes in Case of Detection of Cerebral, Renal or Ophthalmological Fetal Malformations During Pregnancy in Order to Make an Etiological Diagnosis and to Precise the Fetal Prognosis

Congenital malformations concern 3% of pregnancies; most of them can be seen during pregnancy. For some malformations, an invasive sample (trophoblast biopsy or amniocentesis) is proposed to search a chromosomal abnormality by the technique of DNA chip. However, some strongly suggestive signs of a genetic (and not chromosomal) pathology have a very low diagnostic rate with this technique. In the absence of an etiological diagnosis, the prognosis for the unborn child is very difficult to assess, as we can't know if the fetal malformation is really isolated or associted to other unseen features as part of a syndromic condition. For some malformations strongly suggestive of a genetic condition, we propose to realize an exome (i.e. all coding parts of the genome) sequencing of the trio (child and the 2 parents) with a delivery time compatible with the emergency situation of a pregnancy (6 weeks maximum). We will apply bioinformatics filters to analyse only genes known to be involved in the malformation present in the unborn child and thus avoid the identification of variants in unrelated genes. These lists of genes have been previously validated by the Rare Disease Health Sectors and the affiliated diagnostic laboratories. The selected malformations are: 1) anomalies of the central nervous system (microcephaly (<- 2DS) with anomalies of gyration, anomalies of the posterior fossa, anomalies of the midline except agenesis of the corpus callosum), 2) ophthalmological anomalies (microphthalmia, hyperplasia vitreous) and 3) renal abnormalities (large hyperechoic kidneys).

Start: August 2020

Closed-Loop Insulin in Mothers With Type 1 Diabetes and Baby Feeding Practices

This study will is a parallel two-group randomized controlled trial that will use the MiniMed 670G hybrid closed-loop system's continuous glucose monitor (GCM) insulin pump and computer algorithm to deliver insulin when in "auto mode". This study will be conducted in women with type 1 diabetes after delivery of their neonate to see if "auto-mode" improves blood sugar control, episodes of low blood sugar, burden of diabetes self-care, alters baby's weight and feeding patterns, and partner diabetes distress.

Start: July 2020

Dolutegravir in Pregnant HIV Mothers and Their Neonates

To evaluate dolutegravir (DTG) efficacy in women who present with untreated HIV in late pregnancy. An open-label, multi-centre randomised controlled trial of DTG vs efavirenz-based regimens for women commencing cART in late pregnancy. HIV positive pregnant women presenting with untreated HIV infection in late (?28 weeks gestation) pregnancy will be randomised 1:1 to receive DTG (50mg once daily) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) or EFV + 2 NRTIs (SoC)

Start: January 2018

Management of Thyroid Function in Hashimoto's Thyroiditis During Pregnancy

The management of thyroid function in pregnancy has been object of several guidelines in the last years. Normal thyroid function reduces prenatal and post-natal risks and gestational complaints. Trimester specific reference values of thyroid hormones and thyroid stimulating hormone (TSH) are available for selected geographic population but its are not yet are available in our country. Hashimoto's thyroiditis (HT) is the most frequent autoimmune thyroid disease which can induce thyroid dysfunction, mainly sub-clinical hypothyroidism. Due to the large incidence in women HT and its potential link with thyroid dysfunction this disease could be search and monitored before pregnancy. Anyway a strong recommendation is to test TSH levels in all patients seeking pregnancy at risk for thyroid dysfunction for a history or current symptoms/signs of thyroid dysfunction, known positivity od thyroid autoimmunity or goiter, a history of neck radiation, age >30 years, diabetes mellitus, previous infertility or pregnant loss, morbid obesity, living in area of moderate-severe iodine deficiency or recent administration of drugs/substance interfering with thyroid function.

Start: January 2021

Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy

The target population for our study is pregnant women in the first or second trimester with a diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily oral iron supplementation or every other day oral iron supplementation.

Start: October 2020

Global Mental Health of Urban Mothers

Mental health disorders are common during pregnancy and the postnatal period, and can have serious adverse effects on the well-being of woman and child. Every tenth woman has depressive symptoms and 5% suffer major depression during pregnancy. The consequences for global mental health due to the novel coronavirus disease, COVID-19, are likely to be significant and may have long-term impact on the global burden of disease. Pregnant women may be particularly vulnerable due to partial immune suppression. Besides physical vulnerability, the women could be at increased risk of mental health problems, such as anxiety, depression, and post-traumatic stress disorder (PTSD), due to social distancing leading to less support from the family and friends, and in some cases, partners not being allowed to be present during prenatal visits, labor and delivery. Furthermore, many pregnant women may feel insecure and worried about the effect of COVID-19 on their unborn child, if the women get infected during pregnancy. Today, young urban women are used to utilizing internet services frequently and efficiently. Therefore, providing mental health support to pregnant women via web-based support may be effective in ameliorating their anxiety/depression and reduce the risk of serious mental health disorders leading to improved maternal and perinatal outcomes.

Start: November 2020

Evaluation of the Possible Vertical Transmission of SARS-CoV-2 Through Study of Amniotic Fluid and Chorionic Villi of Affected Pregnant Women for the COVID-19

Longitudinal prospective study in pregnant women withpositive serology or PCR for SARS-CoV-2 and indicationinvasive technique (amniocentesis or chorionic biopsy) that has the objective to evaluate the possible vertical transmission of SARS-CoV-2in the amniotic fluid or chorionic villi of pregnant women affected by coronavirus in the different periods of gestation.

Start: August 2020

Elective Induction of Labour at Thirty Nine Weeks: a Prospective Observational Study

Adverse events are considered to increase in pregnancies extending beyond 39 weeks. For multiparous patients, especially those with a favourable cervix, it is perhaps easy to justify an elective induction at 39 weeks given the low risk of caesarean section. However, for nulliparous patients the current evidence, derived mainly from retrospective observational studies, does not allow a clear recommendation with the exception perhaps of the recent A Randomized Trial of Induction Versus Expectant Management (ARRIVE) trial. Given the reported increased risks of adverse events in pregnancies extending beyond 39 weeks it has been hypothesized that a policy of planned elective induction at 39 weeks could improve outcomes for the infant and the mother. There is a trend towards an increased rate of elective labour induction in pregnancies at 39 weeks, indicating that practitioners are more commonly using elective induction at this gestational age. The practice in India varies slightly from institute to institute. The investigator intend to study the maternal and perinatal outcome, after elective induction of labour, at thirty nine weeks and zero days upto thirty nine and six days, amongst nulliparous singleton pregnancies followed up for the duration of their hospital stay, in Jubilee Mission Medical College and Research Institute (JMMC and RI).

Start: July 2019

The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis

Pregnant women with a history of opioid use disorder, chronic opioid use or those who are on medication assisted treatment will be randomly assigned to receive either a sub-fascial continuous infusion of bupivacaine or lidocaine/menthol patch after Cesarean delivery. Post-operative pain scores and opioid usage in the post-operative period will be recorded.

Start: January 2020

Personalized Integrated Chronotherapy for Perinatal Depression

Perinatal depression and anxiety are common, serious, and frequently overlapping disorders that increase morbidity and mortality in new mothers (including suicide) and result in poor infant/child outcomes. Current therapies often fail to produce recovery or are poorly tolerated, and many pregnant women seek non-pharmacologic therapy or forgo treatment when non-pharmacologic options are not available. Expectant and new mothers who experience circadian rhythm dysregulation are at increased risk for perinatal depression. This Confirmatory Efficacy Clinical Trial of Non-Pharmacological Interventions for Mental Disorders R01 seeks to test whether a Personalized Integrated Chronotherapy (PIC) intervention can improve treatment outcomes for pregnant patients seeking outpatient treatment for depression, with or without anxiety. PIC is a multicomponent treatment consisting of bright light therapy, sleep phase advance, and sleep stabilization/restriction that targets the Research Domain Criteria (RDoC) constructs of circadian rhythms and sleep-wake behavior. To increase sample size and diversity and accelerate recruitment, this study will be performed at 4 sites that differ in clinical structure and that have piloted the PIC intervention. The study will enroll expectant mothers diagnosed with major depressive disorder during 3rd trimester of pregnancy. Participants will be randomized to either: (a) usual care (UC, n = 110) or (b) PIC+UC (n = 110). PIC+UC will have pregnancy and postpartum components and will be administered via a personalized approach tailored to optimize the intervention based on each patient's individual circadian and sleep timing. After a baseline assessment, PIC will be prescribed during 5 dedicated clinical visits: three during 3rd trimester of pregnancy and 2 in the postpartum period. UC will consist of medication and/or psychotherapy. UC will be quantified in both groups to evaluate differences between the PIC+UC and UC groups. Mood will be measured in both groups by blinded clinician interview and patient self-report. The safety profile of the PIC intervention will be assessed by evaluation of side effects/adverse events. Importantly, the study will also examine the target mechanisms by which PIC is hypothesized to work and test the mediation effects of the circadian targets on improvement in mood symptoms. Participants will wear wrist actigraphy/light monitors continuously during weeks 28-40 of pregnancy and postpartum weeks 2-6 to assess light exposure and to estimate sleep timing and duration. Circadian phase (measured with salivary dim light melatonin onset) will be measured at baseline during pregnancy (~30 weeks' gestation), at 36 weeks' gestation, and at postpartum week 6. Exploratory aims will examine associations between infant sleep behavior and maternal circadian rhythms and factors relevant to future dissemination of PIC. If this intervention is effective, perinatal PIC could change clinical practice and have major public health impact due to the high prevalence of perinatal depression and anxiety, the negative effects of mood disorders on mothers and their children, and the need to provide effective, novel, non-pharmacologic therapies for women with perinatal mood disorders.

Start: October 2020

Prenatal Iodine Supplementation and Early Childhood Neurodevelopment

A randomized controlled trial to determine the effect of reducing iodine from vitamin and mineral supplements for pregnant women who have adequate iodine intakes (>185 ?g/d from food alone) on cognitive development of children at 24 months of age.

Start: November 2020

Maternal and Fetal Outcomes Following Influenza Vaccination in Pregnancy

This is a nationwide cohort study to assess maternal and fetal outcomes following vaccination with a quadrivalent influenza vaccine (QIV) during pregnancy.

Start: October 2020

Cash Payment and Counseling During Pregnancy

Smoking during pregnancy has harmful effects on both mother and unborn child. Studies have shown that small rewards can help smokers to quit. In our current study, we ask how such rewards are most effective in supporting smoking cessation in pregnancy.

Start: September 2020

Medication Abortion for Pregnancy of Unknown Location

The purpose of this study is to compare time to completed abortion between two protocols for patients seeking medication abortion - same-day start versus delay-for-diagnosis - in the setting of asymptomatic, low-risk, pregnancy of unknown location.

Start: July 2019

Treatment of Pregnancy RA

It is important to control the disease of pregnant women with rheumatoid arthritis to ensure the fetal and maternal health. Frequent disease flare can increase the risk of adverse pregnancy outcomes, including abortion, premature delivery and low birth weight. However, there is no scientific and standardized treatment strategy for RA during pregnancy. About 50% of RA patients need treatment during pregnancy. Tumor necrosis inhibitor (TNFi) is an effective treatment, which can significantly improve the symptoms of RA during pregnancy. However, in order to avoid placental metastasis, TNFi is usually stopped in early pregnancy. Certolizumab pegol (CZP) is a PEGylated, Fc-free TNFi, which does not bind FcRn and is consequently not expected to undergo FcRn-mediated transfer across the placenta. Therefore, it can not transfer through placenta into FcRn and is approved to treat RA during pregnancy. This study focuses on patients with RA who consider pregnancy. We compared the efficacy, safety and economy of CZP and glucocorticoids combined with hydroxychloroquine by a randomized controlled trial.

Start: December 2020

Methionine Requirements During Healthy Human Pregnancy

The current recommendations for dietary amino acid intake in pregnant women are based on calculations from requirements of adult men. The study aims to determine methionine requirements during early (11-20 weeks) and late (31-38 weeks) stages of pregnancy. Methionine, an essential amino acid (building block of body protein), is necessary for protein synthesis and for DNA related cellular functions. A non-invasive, novel method based on different diets, stable isotopes (the safe kind) and simple breath collection will be used. This method has recently been used by our laboratory to study other amino acids during pregnancy.

Start: September 2020

Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study

Assessment of the acceptability by pregnant women on the research of the potential analgesic function of the clitoris.

Start: August 2020

Establish the uSI Values and End-user Training Material That Will be Used to Guide Oxytocin Dosing Actions

Patients receiving oxytocin for induction or augmentation of labor will be studied with uterine EMG. The results of the EMG will be converted to an oxytocin-associated uterine stimulation index (uSI), which is intended to guide decisions for changing the dose of oxytocin. An expert panel will review the results of the oxytocin dosing actions, then assigned optimized actions throughout the labor. The uSI will be correlated with the optimal dosing actions.

Start: April 2021

PED NEONAT 20-000599 Fetal Body Composition

Obesity is an ongoing public health problem that is difficult to treat. There is evidence that obesity has fetal origins. Body composition, including visceral, subcutaneous, brown, and hepatic fat have been found to be important predictors in obesity and metabolic syndrome. Magnetic resonance imaging (MRI) can quantify body composition that does not require radiation but is motion limited. The investigators have developed a motion-compensated MRI sequence, also known as "free breathing" MRI. In this study, the investigators plan to obtain free-breathing MRIs of pregnant women in the third trimester of pregnancy. MRIs will be obtained from healthy mothers, mothers with growth-restricted fetuses, and mothers with gestational diabetes. The different types of adipose tissue will be measured and compared between groups and correlated to birth growth parameters. The goal is this study is to assess if motion-compensated MRI can help predict early growth patterns in infancy.

Start: August 2020

Skin Barrier Assessment in Pregnancy and at Birth

This is a prospective birth cohort study assessing the role of maternal and environmental factors on the development of allergic diseases in children. Pregnant mothers will be enrolled and we will examine her skin barrier with skin tape strips (STS) and transepidermal water loss (TEWL), along with blood work. We will then follow her offspring and perform similar testing, along with detailed questionnaires inquiring about exposures such as use of detergents and soaps, sunlight exposure, and pollution exposure. When the infant is around 12 months old, we will contact the family via telephone to see if the child developed any allergic conditions within their first year of life, such as eczema, food allergy, or wheezing. A final questionnaire will be performed.

Start: August 2020