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Fetal Growth Retardation clinical trials

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NCT ID: NCT04437407 Terminated - Clinical trials for Pregnancy Complications

UniSA BackOff! Study: Adelaide PrenaBelt Trial

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

Stillbirth (SB) is a devastating complication of pregnancy and contributes to over 2 million deaths globally every year. Over 20 million infants are born every year with low birth weight (LBW), which is associated with a twenty times increased risk of death in the first year of life and high rates of short- and long-term illnesses. Sleeping on one's back during pregnancy has recently emerged as a potential risk factor for LBW and SB in the medical literature. In high-income countries, SB rates have mostly remained the same in the past two decades and targeting modifiable risk factors could help reduce the number of SB and LBW in the population. When a pregnant woman sleeps on her back, her body position compresses underlying blood vessels and reduces blood flow to the developing baby. This body position could cause unpleasant symptoms for the mother and result in LBW or SB of her baby. Lying on her side or with a slight lateral tilt helps relieve this compression. One way to keep people off their back while sleeping is by using positional therapy (PT). It is a simple, safe, inexpensive and effective intervention for preventing people who snore or people who's breathing pauses during sleep from sleeping on their back. Reducing the amount of time pregnant women sleep on their back could help reduce SB and LBW rates. The investigators developed a PT device (PrenaBelt) and tested it in three clinical trials, which demonstrated that it significantly decreases the number of time women spend sleeping on their back. Using feedback from our previous research, the investigators developed five additional devices that will be tested in this study. The purpose of this study is to evaluate the new PrenaBelt (PB2) prototypes' ability to reduce the amount of time pregnant women sleep on their backs in the third trimester of pregnancy, validate the Ajuvia Sleep Monitor, and collect feedback on the devices. Demonstrating that the sleeping position of pregnant women can be modified through the use of a simple, inexpensive PT intervention may be one of the keys to achieving significant reductions in LBW and late SB rates in Australia and worldwide.

NCT ID: NCT04084990 Terminated - Clinical trials for Obstructive Sleep Apnea

Sleep Apnea and Fetal Growth Restriction

SAFER
Start date: November 18, 2019
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the association between obstructive sleep apnea (OSA) and fetal growth restriction (FGR) and to assess the role of auto-titrated positive airway pressure (aPAP) as antenatal therapy in these patients. Pregnant patients with diagnosed FGR will be screened for OSA first by screening questionnaire and then by home sleep monitor. Of those patients diagnosed with OSA, half will be assigned to use aPAP each night when sleeping and half will not (standard care).

NCT ID: NCT04047966 Terminated - Clinical trials for Intrauterine Growth Restriction

Study of the Fetal and Maternal Microbiota in Preganant Women With Fetal Defect Growth

BIOCIR
Start date: March 2, 2018
Phase:
Study type: Observational

It is an observational and prospective study that will include consecutively 63 controls (fetuses with estimated fetal weight above the 10th centile) and 63 fetuses with defects in fetal growth (estimated fetal weight below the 10th percentile) during the third trimester (32-26 weeks) with gestational age at birth equal or over 37 weeks. Investigators will collect: (1) Obstetric and nutritional questionnaires, (2) maternal samples between 32-36 weeks (feces), (3) intrapartum samples (maternal blood, cord blood and placenta) and (4) postpartum samples (meconic and newborn feces at 6 weeks of life)

NCT ID: NCT03832634 Terminated - Clinical trials for Fetal Growth Retardation

Fetal Genome Profiling Via Trophoblast Cells

Start date: July 2, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to utilize trophoblast cells accumulating in the endocervical canal at the beginning of pregnancy for non-invasive prenatal testing. If we are able to validate that trophoblast cells obtained at an early gestational age can be reliably used for prenatal testing, there is great potential to improve early pregnancy management and counseling options for potential parents. The target population will be all women between the age of 18-45 undergoing care at the Center for Reproductive Medicine (CRM) in order to achieve a pregnancy.

NCT ID: NCT02442492 Terminated - Clinical trials for Intrauterine Growth Restriction (IUGR)

Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction

STRIDERCan
Start date: January 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Early-onset placental intrauterine growth restriction (EO IUGR) is associated with a high risk of perinatal morbidity and mortality. In association with reduced circulating placental growth factor (PlGF) EO IUGR results from abnormal placentation with inadequate remodelling of the maternal uteroplacental arteries. There is no known treatment for placental IUGR. Management involves intensive fetal surveillance with delivery with evidence of serious fetal compromise. However, remote from term, delivery is associated with significant perinatal mortality and morbidity. Sildenafil vasodilates the uteroplacental vessels of IUGR-affected pregnancies and may represent a novel therapy.

NCT ID: NCT02397291 Terminated - Pregnancy Clinical Trials

Transplacental Gradients and Transport in Intrauterine Growth Restricted (IUGR) Pregnancies Compared to Normal Pregnancies.

Start date: January 2001
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the transplacental gradients for 6 polyols and mannose are altered in intrauterine growth restricted (IUGR) pregnancies compared to normal pregnancies and b) to determine the relative contributions of transplacental transport vs production by the conceptus of both inositol (the major polyol) and mannose in IUGR and normal pregnancies using stable isotopic methodology.

NCT ID: NCT02277132 Terminated - Clinical trials for Fetal Growth Restriction

The Dutch STRIDER (Sildenafil TheRapy In Dismal Prognosis Early-onset Fetal Growth Restriction)

STRIDER
Start date: January 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Rationale: Severe, early-onset fetal growth restriction (FGR) due to placental insufficiency is associated with a high risk of perinatal morbidity with long-lasting sequelae and mortality. Placental insufficiency is the result of abnormal formation and function of the placenta (placentation) with inadequate remodelling of the maternal spiral (uteroplacental) arteries. There is currently no therapy available with demonstrated effectiveness. Evidence suggests Sildenafil citrate improves uteroplacental blood flow, growth, and meaningful outcomes. Objective: To evaluate the effectiveness of sildenafil (versus placebo) in achieving healthy perinatal survival. Study design: Multicenter nationwide randomized placebo-controlled clinical trial. Study population: Women with a singleton pregnancy between 20 and 30 weeks with severe fetal growth restriction of likely placental origin, and with estimated significant likelihood of perinatal death. Intervention: Sildenafil 25mg or placebo tablet orally three times daily. Main study parameters/endpoints: Perinatal healthy survival, i.e. survival without severe neonatal morbidity at term age. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Taking tablets three times daily. No additional ultrasounds, other than standard clinical protocol, one extra blood sample at inclusion. No risks anticipated, unexpected medication-associated risks can't be excluded on beforehand.

NCT ID: NCT01944306 Terminated - Obesity Clinical Trials

Obesity and Oral Contraceptive Failure

Start date: August 2013
Phase:
Study type: Observational

Contraceptive failure is the primary cause of unintended pregnancy in the United States. With obesity rates at epidemic proportions, any association between obesity and strategies that prevent undesired pregnancies constitutes a significant public health and economic concern. Evidence from recent epidemiological studies and our preliminary data (sub-therapeutic levels of steroid hormones due to drug clearance and half-life) suggest that obesity reduces oral contraceptive efficacy. Furthermore, preliminary analysis suggested that a sub-group of obese women, defined by their own birth weight, are at higher risk of contraceptive failure. Further studies are necessary to investigate whether birth weight, a surrogate marker of in utero growth restriction, is a useful diagnostic marker for the identification of women prone to contraceptive failure. Such an understanding is critical to finding a contraceptive strategy with better efficacy for these women. The overall goal of this project is to test pharmacokinetics of oral contraceptive agents in obese women with low birth weight and compare to obese women with normal birth weight. The main hypothesis for this proposal is that an adverse in utero environment programs the expression and function of enzymes and transporters that underlie pharmacokinetics of oral contraceptives, and leads to contraceptive failure. Reproductive-aged, ovulatory women of obese BMI >30 kg/m2 with normal birth weight (5.5-8 lbs; n=10) and low birth weight (<5.5 lbs; n=10), will be placed on oral contraceptives for 1 month. At several key time points, synthetic steroid pharmacokinetics, gonadotropins (luteinizing hormone, follicle-stimulating hormone) and ovarian hormone levels (estradiol, progesterone) will be monitored.

NCT ID: NCT00549575 Terminated - Clinical trials for Intra Uterine Growth Retardation

L-Arginine Treatment for Severe Vascular Fetal Intrauterine Growth Restriction: a Randomized Double Bind Controlled Trial (L Arginine in IUGR)

Start date: July 2000
Phase: Phase 3
Study type: Interventional

Although there is a strong rationale to supplement gravid patients suffering intrauterine growth restriction (IUGR) or preeclampsia with Arginine or other nitric oxide donors, evidence in the literature has been inconclusive. The current study was designed to determine whether oral treatment with L-Arginine, a nitric oxide (NO) donor, would enhance birth weight and/or decrease neonatal morbidity in pregnancies with severe vascular intrauterine growth restriction (IUGR).

NCT ID: NCT00260520 Terminated - Preeclampsia Clinical Trials

LMWH to Prevent Preeclampsia and Fetal Growth Restriction

Start date: January 2002
Phase: Phase 4
Study type: Observational

The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both.