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Pregnancy clinical trials

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NCT ID: NCT03632863 Not yet recruiting - Depression Clinical Trials

PDA for Antidepressant Use in Pregnancy

Start date: September 2018
Phase: N/A
Study type: Interventional

Depression in pregnancy is common, affecting up to 10% of women and represents serious risk to mother and infant. Unfortunately, antidepressant medication, a first-line treatment for depression in pregnancy, also comes with risks, making this a complex decision. Clinical care appears to be insufficient for ensuring that women make decisions that are consistent with their own values and with which they feel satisfied. Patient decision support tools can address such barriers. We have created and piloted with positive results an online patient decision aid (PDA) that has the potential to improve the decision-making process for women regarding antidepressant use in pregnancy in conjunction with clinical care. The overall objective of this study is to conduct a Randomized Controlled Trial (RCT) to assess the efficacy of our PDA for antidepressant use in pregnancy.

NCT ID: NCT03620110 Recruiting - Pregnancy Clinical Trials

A Study Collecting Blood Samples From Pregnant Women to Aid in the Development of a Noninvasive Prenatal Test

Start date: May 21, 2018
Phase:
Study type: Observational

The purpose of this study is to collect whole blood samples from women with viable pregnancies of at least 10 weeks gestation (at any risk for fetal chromosomal anomaly) for future testing with an investigational noninvasive prenatal test(s) (NIPTs), and to establish clinical truth compared to a clinical reference standard.

NCT ID: NCT03615261 Recruiting - Pregnancy Clinical Trials

Wellness For 2: A Feasibility and Acceptability Pilot

We2-P
Start date: July 30, 2018
Phase: N/A
Study type: Interventional

The investigators are studying strategies and tools that women can use to manage stress and wellness during pregnancy. The purpose of this project is to test a technology-enhanced version of a wellness intervention for women during their pregnancy (the Mothers and Babies course; MB). The technology that the investigators will test includes wearable heart rate sensors, smartphone text message surveys, and intervention materials delivered through text message.

NCT ID: NCT03609086 Recruiting - Pregnancy Clinical Trials

Melatonin in Pregnancy

MEL-P2
Start date: June 6, 2018
Phase:
Study type: Observational

Melatonin is well known for its role in the sleep-wake cycle and is synthesised in response to low light levels from the pineal gland. In our previous study it was found that serum melatonin levels increased dramatically during pregnancy, such that levels were up to 100 fold higher in the third trimester compared to healthy non-pregnant women. The placenta contains the enzymes which are involved in synthesising melatonin but it is unclear if this is the source of the high levels in pregnancy. Severe pre-eclampsia has been reported to be associated with low levels of melatonin. In this study its is proposed to measure serum melatonin immediately before and after delivery and in cord blood and relate the levels to those in the placenta itself. This will contribute to the potential role for melatonin as a biomarker for obstetric disease and potentially as a therapeutic agent in future. This observational pilot study aims to measure serum and placental melatonin levels (as the major metabolite 6-hydroxymelatonin sulphate) in pregnant women undergoing elective Caesarean section.

NCT ID: NCT03607929 Recruiting - Pregnancy Clinical Trials

HIDRATA Study: Efficacy of a Hydration Protocol in Nulliparous Women During Labor

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

Aim. To evaluate the efficacy of optimizing hydration during labor in nulliparous women with respect to reducing the duration of dilation and the second stage of labor, lowering the incidence of Cesarean sections and fever, and also with respect to changes in sodium and osmolarity in blood and urine, and 24 hour diuresis. Background. In the international scientific community there is a lack of consensus regarding the most suitable hydration strategies to be used in the attention of nulliparous women during low risk birth. Insufficient hydration during labor is associated with increased maternal and neonatal morbidity. Design. A randomized, controlled clinical trial with allocation concealment and masking during the evaluation of the results. Methods. A study of nulliparous women whose births and newborn are attended in the Obstetric Service of a University Hospital. The women will be randomized to two groups: the "optimal hydration" group, that will be guaranteed 300 ml/h (intravenous crystalloids and water) with a minimum diuresis of 400 ml/24h; and the "variability in hydration" group, comprised of the administration of intravenous and clear liquid volumes, without any established perfusion rate, based on criteria established by the healthcare professional attending the birth, and without established minimum diuresis. Mother outcomes: duration of labor, Cesarean section, fever, dehydration. Newborn outcomes: distress, hypoglycemia, hyponatremia, jaundice, weight loss in 48h, breastfeeding difficulties. Analysis will be per-protocol. Statistical significance will be set at p<0.05 Discussion. The findings obtained in this study will provide new evidence for considering the benefits of providing women with suitable optimized hydration during labor. Diminishing the clinical practice variability related to hydration strategies applied to nulliparous women attended during labor through the use of a decision-making algorithm to administer optimal hydration, would imply improved health and safety for mothers and their newborn together with reduced maternal and neonatal morbidity. Funding granted in 2015 by the Spanish Health Research Fund (PI 15/00897, Ministry of Health). Keywords: hydration; dehydration; adverse events; labor; Cesarean section, fever.

NCT ID: NCT03602196 Not yet recruiting - Pregnancy Clinical Trials

In Vivo Assessment of the Elastic Properties of Women's Pelvic Floor During Pregnancy

ELASTOPELV
Start date: July 2018
Phase: N/A
Study type: Interventional

The investigators hypothesize that optimize our risk prediction for pelvic floor disorders after childbirth by taking into account intrinsic women's pelvic floor characteristics and their changes during pregnancy. Shear Wave Elastography (SWE) is a new technology that allowed an in vivo assessment of elastic properties of tissues. The main endpoint of this study is to describe biomechanical changes that occurs into women's pelvic floor during pregnancy using SWE technology.

NCT ID: NCT03593980 Recruiting - Pregnancy Clinical Trials

Gastric Emptying of 400 ml of a Carbohydrate-rich Beverage in Women Admitted for Elective Cesarean Delivery

Start date: August 8, 2018
Phase: N/A
Study type: Interventional

Because of the risk of pulmonary aspiration, patients are asked to comply with the fasting guidelines when they are scheduled for an elective cesarean section. This fasting can result in increased insulin resistance, and that this can delay patient recovery from surgery. Giving a patient a carbohydrate-rich beverage before surgery has been shown to reduce the post-operative insulin resistance and reduce the length of stay in the hospital. In order to safely provide pregnant women with a carbohydrate-rich drink when admitted to the hospital in preparation for an elective cesarean delivery, the investigators must ensure that their stomach has emptied by the time they go to the operating room. The objective is to investigate whether women admitted to the hospital, having complied with the fasting guidelines, will have an empty stomach 2 hours after being offered 400 ml of a beverage containing 50g of carbohydrate. This can easily be done with the use of an ultrasound exam of the stomach. The hypothesis is that patients will have an empty stomach 2 hours after drinking 400 ml of a carbohydrate-rich beverage.

NCT ID: NCT03585361 Completed - Pregnancy Clinical Trials

Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) in Ethiopia

Start date: February 20, 2017
Phase: N/A
Study type: Interventional

This study is investigating whether use of postpartum family planning (PPFP) increases if messages on PPFP and, if desired, PPFP services are integrated into as many contacts as possible between women/couples and the health system during pregnancy and the first year after birth. Health system contacts may be at health facilities (including antenatal, labor and delivery, postnatal, and child immunization visits) or, with Ethiopia's Health Extension Program, at households or health posts in the community.

NCT ID: NCT03574506 Active, not recruiting - Pregnancy Clinical Trials

Eculizumab Use in the Postpartum Period for the Treatment of Pregnancy Associated aHUS: A Case Series

Start date: April 15, 2018
Phase:
Study type: Observational

Eculizumab is a humanized monoclonal IgG antibody against protein C5 that works to inhibit the activation of the terminal complement cascade. The Eculizumab is currently FDA approved for the treatment of Paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome (aHUS) and has been shown to improve the quality of life and overall survival in these patients. aHUS is a life-threatening disease of complement mediated thrombotic microangiopathy often triggered by an inciting event, such as an infection or immunocompromised state. Pregnancy has also been identified as an inciting event, with patients most often experiencing aHUS in the postpartum period. Due to its rare nature, pregnancy-associated aHUS is often mistaken for preeclampsia or hemolysis, elevated liver enzyme, low platelet (HELLP) syndrome. As standard treatment for preeclampsia and HELLP syndrome is completion of the pregnancy by expediting delivery of the baby. A missed diagnosis of aHUS can result in delays in treatment, including use of Eculizumab when appropriate; such delay can increase the risk of maternal morbidity and mortality. When aHUS is suspected in the postpartum period, Eculizumab could be initiated early; however, there is limited data on use of Eculizumab in this setting.

NCT ID: NCT03567070 Completed - Pregnancy Clinical Trials

Pregnancy and Use of Psychoactive Substances: The Influence of Representations of Care on Care.

ADDGEST
Start date: March 17, 2017
Phase: N/A
Study type: Interventional

It is observed that pregnant women using psychoactive substance (s) have a more random and more accidental pregnancy follow-up than women with no addictive problems. The consumption approach can be either omitted during the pregnancy monitoring, or entrusted to the course or more often in late pregnancy or occurs more brutally during delivery at the time of complications (neonatal or obstetric). In this context, health professionals are looking for levers that allow women to take appropriate care quickly. This difficulty of access to care questions us and all the more because the time of the pregnancy is a moment of important psychic reorganization conducive to modify its habits, to change its glance on its consumptions and thus to start a care concerning addiction. Invesigators hypothesize that this population has less access to medical care during pregnancy for fear of stigmatization by the health care provider. Invesigators propose a multicenter qualitative study based on individual clinical interviews to collect the testimony of women who used psychoactive substance (s) during their pregnancy. The purpose of this work is to identify ways to improve the multidisciplinary medical management of these women by focusing on the representations they can make care of.