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Pregnancy clinical trials

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NCT ID: NCT03149965 Completed - Obesity Clinical Trials

Maternal Body Mass Index and Anovaginal Distance

AVD
Start date: October 2, 2014
Phase: N/A
Study type: Interventional

The hypothesis was that the anovaginal distance (AVD), defined as the distance between the anal mucosa and the vaginal wall at the middle level of the anal canal, is higher in obese women compared with normal weight women. Measuring the AVD with transperineal ultrasound has been shown to have a high interobserver agreement. This study aimed to establish if there was a difference in AVD measured by transperineal ultrasound between obese and normal weight women in active phase of labor at term pregnancy. The second aim was to present normal values for the AVD in active phase of labor at term pregnancy.

NCT ID: NCT03141320 Completed - Pregnancy Clinical Trials

Confident Birthing: What Influences Women's Confidence for Birth?

Start date: February 1, 2016
Phase:
Study type: Observational

This is a grounded theory study aiming to understand women's perception of what influences their confidence for birth during labour and birth. Data is being collected using interviews and social media sources.

NCT ID: NCT03140709 Completed - Pregnancy Clinical Trials

Non-Invasive, Highly Specific Detection of Oxytocin in Biological Fluids

Start date: May 2016
Phase: N/A
Study type: Observational

This study will aid in the development of a research instrument for rapid and highly sensitive detection of perinatal salivary oxytocin, by non-invasive means. There will be two study cohorts: Induction of labor cohort (20) and Cesarean delivery cohort (5) for a total of 25 participants.The standard clinical protocols for administering oxytocin to human subjects at Lucile Packard Children's Hospital will be followed. Oxytocin will be prescribed and dosed as per standard of care with no change due to study enrollment. The study will only involve sampling of saliva and blood. The general hypothesis to be tested is that 1) the sensor will accurately report the levels of oxytocin in saliva samples as compared with standard reference methods and 2) the sensor yields rapid (<20 minutes) oxytocin results with minimal discomfort to subjects. Overall, this will allow to optimize the administration of oxytocin, and for a better understanding of the blood concentration and effects of oxytocin on mother and child.

NCT ID: NCT03137251 Completed - Pregnancy Clinical Trials

Evaluation of the Effectiveness of Transcutaneous Electrical Nerve Stimulation During Labor.

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of the Transcutaneus Electric Nerve Stimulation (TENS) during the labour. TENS is a low frequency electrotherapy technique, analgesic type, generally used in musculoskeletal pathology. The investigators will have three groups of participants to be administered the TENS, a different dose in two groups, while the third will correspond to placebo. The hypothesis of the study is to verify if the TENS is effective as a non-pharmacological method in the relief of pain during childbirth

NCT ID: NCT03134274 Recruiting - Pregnancy Clinical Trials

Study Assessing the Usability and Patient Satisfaction With Digital Urinalysis in the Context of Routine Pre-natal Care.

Start date: May 7, 2017
Phase: N/A
Study type: Interventional

The study is a home-based, usability study assessing the use of the Dip Home-Based Dipstick Analyzer (HBDA) in the context of prenatal care.

NCT ID: NCT03132207 Completed - Pregnancy Clinical Trials

The 4th Month Oral Consultation at Pregnant Women

C4M
Start date: June 1, 2017
Phase:
Study type: Observational

Epidemiological studies have suggested that maternal periodontitis affects the fetal-placental unit, with an increased risk of adverse pregnancy outcome. Indeed, it has been suggested that the direct or indirect action of parodontopathogenic bacteria induces an inflammatory cascade that leads to spontaneous premature labor. Also, non-treatment of caries and periodontal disease can lead to acute pain and stress. This may promote self-medication and the inappropriate use of analgesic medications, potentially harmful to the health of the fetus. As part of the prevention of complications of pregnancy associated with oral diseases, the National Agency for Accreditation and Evaluation in Health (ANAES) has set up a system that allows any pregnant woman to consult between the 4th and 7th month of pregnancy, an oral health professional to carry out a complete assessment and free care. This study aims at evaluating this device among pregnant women and healthcare professionals 4 years after its implementation. On the other hand, it will make it possible to look for a possible link between the realization of an oral prenatal follow-up and the outcome of the pregnancy.

NCT ID: NCT03098407 Completed - Pregnancy Clinical Trials

Opioid Dependence Treatment Therapies in Pregnancy

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

The incidence of opioid dependence in pregnancy increased over the last decade from 1.2 to 5.8 per 1,000 hospital births per year.1 While methadone is the current, standard treatment for opioid dependent (OD) pregnant women, buprenorphine recently emerged as an alternative. In a recent clinical trial (MOTHER), buprenorphine was associated with superior neonatal outcomes such as shorter duration of treatment for neonatal abstinence syndrome (NAS) compared to methadone. However, buprenorphine was also associated with greater study discontinuation (33% vs. 18%) and illicit opioid use (33% vs. 23%) compared to methadone. Treatment dropout often leads to relapse and resumption of high-risk behaviors, overshadowing any short-term improvement in neonatal outcomes. Therefore, The goal of this K23 proposal is to conduct a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone programs for the treatment of OD pregnant women. A pilot study is critical to develop the outcome measures, assessment tools and participant tracking techniques necessary for a future, large-scale comparative effectiveness clinical trial. An examination of feasibility and acceptability will also allow use to characterize the subpopulations of OD pregnant women willing to participate in treatment randomization, identify patient and provider characteristics associated with established treatment preferences and inform the development of strategies to improve participation and enhance the generalizability of the future large-scale clinical trial.

NCT ID: NCT03095053 Completed - Pregnancy Clinical Trials

PGT-A Versus Blastocyst Morphology Selection

Start date: March 23, 2017
Phase: N/A
Study type: Interventional

Introduction Embryo aneuploidy is likely the leading cause of implantation failure in IVF cycles. Since the inception of IVF, non-invasive morphology based scoring has been the most widely used embryo selection method, resulting in relatively low embryo implantation rates. Our understanding of the optimal conditions required for in vitro embryo culture in IVF has advanced significantly over the past two decades. The implementation of improved in vitro embryo culture technologies (i.e., culture media and incubators) has resulted in an increase in the number of good quality embryos and consequently in increased numbers of blastocysts. While blastocyst transfers have seemingly improved the reproductive outcomes of IVF, they still remain suboptimal. The main objective of this randomized controlled trial (RCT) will be to investigate whether preimplantation genetic testing (i.e., PGT with comprehensive chromosome screening (CCS)) for aneuploidy is a superior embryo selection method, with the live birth outcomes of euploid blastocyst frozen embryo transfers (FET) compared with the LB outcomes of unknown-ploidy blastocyst FET, with blastocysts selected on (standard) morphological score. Methods This RCT will be conducted at a single private IVF centre performing routine segmented-IVF, with intracytoplasmic sperm injection (ICSI), blastocyst freeze-all, and artificial frozen embryo transfer (art-FET). Normo-ovulatory infertile patients, with maternal age ≤35 years and at least two blastocysts with a morphology score of 2BB cryopreserved, will be randomized by computer-generated randomized allocation to either the PGT or morphology arm of the trial. All transfers will be single embryo transfers (SET), with only the first FET cycles following freeze-all to be analyzed. Consent and Ethics Akdeniz University Medical Faculty Clinical Research Ethics Committee has approved the trial (reference number: 2015/399), with anonymized results to be released in ClinicalTrials.gov. All patients will provide informed consent, which included an agreement for the use of anonymised data for research and SET.

NCT ID: NCT03084627 Active, not recruiting - Pregnancy Clinical Trials

Evaluation of the Efficiency of Tailored Dietary Advice in Improving the Nutrient Adequacy of the Diet of French Pregnant Women

MONCAP
Start date: September 20, 2016
Phase: N/A
Study type: Interventional

Pregnancy is associated with an increase in nutrient requirements. During this period, women would be keener on adopting healthier behaviors. Thus, pregnancy represents an opportunity to improve the nutrient adequacy of the diet of mothers-to-be. This study is a randomized controlled trial, which aims at evaluating the efficiency of a tailored dietary advice tool in improving the nutrient adequacy of the diet of pregnant women, as measured by the PANDiet. Eighty pregnant women will be included in the study and randomized either in the "control" group, or in the "intervention" group. The control group will receive generic dietary advice based on a booklet edited by the French Institute for Health Promotion and Health Education (INPES). The intervention group will receive the same generic dietary advice plus tailored dietary advice to improve the nutrient adequacy of their observed diets. Dietary intakes will be evaluated online using a 3 days food record, at baseline and 6 weeks after patients received the booklet and/or the first tailored dietary advice. Thus, the nutrient adequacy of the diet could be evaluated before and after the intervention in both groups. The dietary follow-up for one patient will last 12 weeks only, but data will be collected at delivery. "Moreover, after, the 12-week dietary follow-up and before their deliveries, 10 participants (5 by group) will be contacted to participate in a qualitative interview. This interview will aim at understanding barriers and motivators to implement dietary advice (generic and/or tailored) in the diet of pregnant women in the study.

NCT ID: NCT03080337 Terminated - Diabetes Clinical Trials

Group vs. Traditional Diabetes Prenatal Care

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

This study aims to use an innovative and integrated educational curriculum to deliver prenatal care and diabetes care for pre-gestational diabetic women from approximately the first trimester of pregnancy through delivery and the early postpartum period in a group care model. The group care model will be compared to a control group, a traditional, individual care model.