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Pregnancy clinical trials

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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: NCT03079388 Completed - Pregnancy Clinical Trials

Nutritional and Anti-infective Interventions for Malnutrition in Pregnancy (Beleuman Welbodi)

Start date: February 27, 2017
Phase: N/A
Study type: Interventional

Acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their unborn children. Undernutrition during pregnancy can result in maternal complications such as life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications such as intrauterine growth retardation, low birth weight, pre-term delivery and poor cognitive development. Poor women in the developing world are at heightened risk of malnutrition due to inadequate dietary intake and are subject to transmission of a number of infections including malaria, intestinal helminths, and genitourinary infections. Food interventions for malnutrition may be less effective under conditions with excessive inflammation and infection, and especially so during pregnancy. Without specifically addressing treatment for infections, undernourished mothers may be less responsive to nutritional interventions. The benefits of treating both malnutrition and common infections simultaneously remain largely unstudied. This study tests the hypothesis that malnourished pregnant women receiving 100 grams per day of a specially formulated ready-to-use supplementary food in addition to a combination of 5 anti-infective interventions will have greater weight gain in pregnancy and deliver larger, longer infants than women receiving the standard of care. The outcome of the pregnancy and maternal nutritional status will be followed until 6 months after delivery.

NCT ID: NCT03072277 Completed - Pregnancy Clinical Trials

Maternal DHA Supplementation and Offspring Neurodevelopment in India (DHANI-2)

DHANI-2
Start date: December 2015
Phase: Phase 3
Study type: Interventional

DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal supplementation (DHA or Placebo) from <20 weeks of gestational age through 6 months postpartum and infant follow-up through 12 months. Leveraging the Randomized Controlled Trial (RCT) design, DHANI-2 aims to assess the role of maternal DHA supplementation on infant neurodevelopment and body growth. It also intends to enhance the mechanistic understanding by the addition of repeated biochemical measures from mother-child dyads.

NCT ID: NCT03065842 Completed - Pregnancy Clinical Trials

A Pre and Post Test Intervention Design to Prevent Abortion and Contraceptive-use Stigma Among School Youths in Kenya

SAC
Start date: February 5, 2017
Phase: N/A
Study type: Interventional

In many low-income countries, unsafe abortion is recognized as a leading cause of maternal morbidity and mortality. Social stigma surrounding abortion and contraceptive use plays a critical role in the social, medical, and legal marginalization of abortion and contraceptive services. Though this stigma is pervasive and threatens women's health, it is not well understood how it can be reduced. The Stigmatizing Attitudes, Beliefs and Actions Scale (SABAS) was designed in 2013, to measure abortion stigma at individual and community level. Objective: I) to conceptualize abortion stigma among; health care providers, secondary school teachers and students, and II) to determine if a school based intervention targeting stigma specifically faced by girls when accessing abortion and contraceptive services, compared to usual standards, will decrease related stigma and increase contraceptive use among students, who are sexually active. Design, Setting, Participants: I) Focus group discussions (FGD) with service providers at YFC (n=12), secondary school teachers (n=16) and secondary school students (n=20), and II) a quasi-experimental pre- and post-intervention study, targeting 800 secondary school students (14-20 y), in Kisumu, Kenya. Two schools will be assigned; one interventions unit (n=400 students) and one control unit (n=400 students). The schools are similar according to the study site, size and academic standards. The region is chosen because of its low rate of contraceptive use, and high rate of teen pregnancy and of unsafe abortions. Standard deviation is the measure of dispersion or variability in the data. The sample size of 400 is based on a previous study and will give a power of 80% to detect differences (95% Cl) between the two groups. Intervention: An abortion- and contraceptive-use stigma reduction intervention (1-month program), capturing negative stereotypes about women that are associated with abortion and contraceptive use. Main Outcome: Abortion-stigma reduction. Secondary outcome: Contraceptive-use stigma reduction. Measured at baseline (pre-test), and post-test at 1- and 12-months, by using the validated SABA-scale. Analyses: Qualitative content analysis and repeated measures, ANOVA. Funded by: The Swedish Research Council for Health, Working Life and Welfare 2015-01194, and The Swedish Research Council 2016-05670

NCT ID: NCT03063528 Completed - Pregnancy Clinical Trials

Healthy Motivations for Moms-to-be Study

HM2B
Start date: January 5, 2017
Phase: N/A
Study type: Interventional

This proposal is part of a broader research agenda that posits healthy gestational weight gain (GWG) may be achieved through behavioral intervention and may potentially reduce adverse maternal and infant health outcomes associated with excessive weight gain during pregnancy. The purpose of this study is to examine the use of a mobile application (mobile app) and mobile website for encouraging and maintaining healthy behaviors such as healthy eating, regular exercise, and stress management and reduction during pregnancy. The study will include collaborative group-based health behavior challenges for pregnant women living in the United States. The study will test the effectiveness of the intervention on improving maternal health behaviors. The proposed research project will examine if an intervention targeting healthy eating and exercise leads to significantly less weight gained during pregnancy versus a comparison group that receives stress reduction and management content.

NCT ID: NCT03062228 Completed - Pregnancy Clinical Trials

KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section

KBTH-HBWS
Start date: April 28, 2016
Phase:
Study type: Observational

This study was designed and conducted in an effort to establish a comparison group for the Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth weight, of a belt-like device to help pregnant women to avoid sleeping on their back during sleep in the third trimester. This study will seek to establish the typical birth weight of babies born to a cohort of healthy pregnant Ghanian women who are similar in characteristics to the women in the Ghana PrenaBelt Trial but who have not been educated to avoid back sleep during pregnancy nor have received a device to prevent back sleep.

NCT ID: NCT03051867 Completed - Pregnancy Clinical Trials

Vitamin D Status and Metabolism in Human Pregnancy

Start date: January 15, 2009
Phase: N/A
Study type: Observational

The purpose of the present study is to understand the effect of pregnancy on vitamin D metabolism and requirements as well as the modulatory role of the placenta in vitamin D metabolism during pregnancy. In addition, a human placental cell culture model will be employed to examine vitamin D metabolic flux in human trophoblast cells. The impact of maternal vitamin D status on maternal and fetal bone health during gestation will also be examined.

NCT ID: NCT03030443 Completed - Clinical trials for Pregnancy Termination in First Trimester

Patient Preferences in Anesthesia for Abortion Care

PAC
Start date: April 4, 2017
Phase:
Study type: Observational

This study will use semi-structured interviews with participants in a prospective cohort study to explore women's experiences of pain and preferences in pain management during first trimester surgical abortion to create a more patient centered experience. We will analyze two study cohorts of women undergoing first trimester surgical abortion: women choosing oral anesthesia and women choosing nitrous oxide.

NCT ID: NCT03009526 Completed - Pregnancy Clinical Trials

Efficacy and Safety of IPTp-DP Versus IPTp-SP in Malawi

STOPMIP-MW
Start date: January 17, 2017
Phase: Phase 3
Study type: Interventional

This study aims to compare the efficacy of monthly IPTp-DP with monthly IPTp-SP to determine if IPTp-DP is associated with a reduction in malaria infection at delivery among HIV-negative women in an area with high levels of SP resistance in Malawi.

NCT ID: NCT03002987 Completed - Pregnancy Clinical Trials

Active Pregnancy Policy at Work. Greater Wellbeing and Lower Sickness Absence

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

In a cluster randomized design it will be investigated whether teaching local leaders how to implement active pregnancy policy results in less sickness absence among their pregnant employees. Further it will be investigated to what extent Active pregnancy policy is implemented at the departments and whether it results in higher sense of security and wellbeing among the pregnant employee. Finally the cost and benefits of the intervention will be analyzed.