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Pregnancy Preterm clinical trials

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NCT ID: NCT06110143 Recruiting - Inflammation Clinical Trials

Oral Health and Adverse Pregnancy Complications

Start date: November 13, 2021
Phase: N/A
Study type: Interventional

Pregnant women are susceptible to develop periodontitis, but these oral health changes related to pregnancy are often neglected. Periodontitis is accompanied by a low-grade systemic inflammation and can be harmful to the general health of the woman, contribute to pre-term birth and adversely influence the future health and metabolism of the offspring. Despite this, studies indicate that 40% of Danish women in childbearing age do not visit a dentist regularly. The PROBE controlled intervention study will investigate the beneficial effect of treatment of periodontal disease during pregnancy on fetal growth, preterm delivery and birth weight.

NCT ID: NCT05651347 Recruiting - Clinical trials for Fetal Growth Retardation

Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction

PROTECTMe
Start date: May 29, 2019
Phase: Phase 3
Study type: Interventional

Fetal growth restriction (FGR) is a significant health care issue, affecting 20,000 Australian pregnancies every year. Undetected FGR is one of the key risk factors for stillbirth, but FGR can also cause significant impairments in short and long-term health outcomes for the child. It is a major risk factor for preterm birth and is a recognised causal pathway to the neurodevelopmental injury underlying cognitive and behavioural impairment and cerebral palsy. Current obstetric care is focused on the detection of the growth restricted fetus and then ultrasound assessment of fetal wellbeing to guide timing of delivery. This approach seeks to maximize the gestational age of the fetus at delivery to minimise the risks of prematurity, while delivering the fetus in time to reduce the likelihood of stillbirth. Currently, no therapies exist that can maximize fetal wellbeing in the setting of growth restriction and minimise the frequency of antenatally acquired brain injury due to in-utero hypoxia. This triple-blind, randomized, parallel group, placebo-controlled trial will administer maternal melatonin or placebo supplementation antenatally in the setting of early-onset severe FGR to determine whether melatonin can PROTECT the fetal brain and lead to improved neurodevelopmental outcomes.

NCT ID: NCT05520021 Recruiting - Pregnancy Preterm Clinical Trials

The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat

MgSO4
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Comparison of the effects of Nifedipine and MgSO4 therapies on maternal and fetal blood flow.

NCT ID: NCT05430633 Completed - Appendicitis Clinical Trials

Laparoscopic Versus Open Appendectomy in Pregnancy

Start date: November 1, 2021
Phase:
Study type: Observational

The aim of this retrospective trial is to compare surgical and pregnancy outcomes of pregnant patients who underwent laparoscopic or open appendectomy for acute appendicitis.

NCT ID: NCT05412056 Not yet recruiting - Preterm Birth Clinical Trials

Metformin to Prevent Preterm Birth in Twin Pregnancy

TwinMet
Start date: June 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Preterm birth (PTB) is a major challenge to perinatal health. It accounts for 75% of perinatal deaths and more than 50% of long-term neurological disabilities. Neonates born preterm are also at risk of significant comorbidities, for example respiratory distress syndrome, chronic lung disease, retinopathy of prematurity, necrotizing enterocolitis, intraventricular haemorrhage and sepsis in the short term, as well as cerebral palsy, motor and sensory impairment, learning difficulties, and increased risk of chronic disease in long run. Twin pregnancy is associated with a higher risk of PTB when compared to singleton pregnancy. The National Vital Statistics reveals the PTB rate is 8.2% and 60.3% in singleton and twin pregnancy respectively in 2018. The mechanism of PTB in twin pregnancy is not completely understood and may be different from that of singleton pregnancy. At present, there are no good strategies to prevent PTB in twin pregnancy. In singleton pregnancy, metformin has been used for the treatment of gestational diabetes in pregnant women with obesity/ overweight or polycystic ovarian syndrome (PCOS). The rate of PTB of pregnant women with PCOS is significantly lower after using metformin. A decreasing trend of PTB is also noted after metformin use in obese pregnant women without PCOS. There is no study to investigate the effect of metformin in twin pregnancy. Premature uterine and amnion stretching in twin pregnancy can trigger preterm labour by increased prostaglandin synthesis and interleukin-1, activation of activator protein-1, expression of connexin-43 and stimulation of stretch dependent focal adhesion signaling. Inflammation is another risk factor for PTB. Metformin is an anti-inflammatory agent which can suppress inflammatory cytokines production and downregulate AMP-activated protein kinase medicated connexin-43 and nuclear factor κB activation. Anti-inflammatory actions of metformin can also reduce production of nitric oxide, prostaglandin E2 and pro-inflammatory cytokines through inhibition of NFκB activation in macrophages. Another possible mechanism to prevent PTB is the inhibition of mammalian target of rapamycin complex 1,which has a role in the timing of birth, by AMP-activated protein kinase. Therefore, metformin can be potentially used to prevent PTB in twin pregnancy. However, its effect in twin pregnancy has not been studied. The objective of the study is to determine if the use of metformin in twin pregnancy can prevent PTB.

NCT ID: NCT05345457 Recruiting - Premature Birth Clinical Trials

Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age

Start date: January 13, 2023
Phase: Phase 4
Study type: Interventional

A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.

NCT ID: NCT05264779 Recruiting - Premature Birth Clinical Trials

The Periviable GOALS Decision Support Tool

Start date: June 6, 2022
Phase: N/A
Study type: Interventional

The Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool (DST) is meant to facilitate informed shared decision-making regarding neonatal resuscitation for families facing the threat of a periviable delivery (deliveries occurring between 22 0/7 - 25 6/7 weeks gestational age). It is designed for parents to review independent of their clinician, and is intended to supplement, not replace, clinician counseling. The focus of the DST is the provision of patient-centered outcomes information and assistance with values clarification regarding neonatal outcomes. This is a multisite, randomized controlled trial to test the effect of the Periviable GOALS DST on shared decision making and decision satisfaction. The investigators hypothesize that participants who utilize the GOALS DST will have improved shared decision making and higher decision satisfaction.

NCT ID: NCT04989673 Completed - Fever Clinical Trials

Materno-fetal Consequences of Symptomatic Dengue in Pregnant Wowen in French Guiana

CMFdeng
Start date: July 11, 2012
Phase:
Study type: Observational

Symptomatic dengue virus infection in pregnant women could affect the mother, fetus and the newborn at birth. The risks of postpartum hemorrhage, prematurity and low birth weight are increased in dengue fever. Cases of vertical transmission have been described. This study therefore proposes to quantify these risks in a pregnant woman presenting a clinical picture of dengue fever through a prospective, longitudinal and comparative study.

NCT ID: NCT04433364 Active, not recruiting - Covid-19 Clinical Trials

COPE - COVID-19 in Pregnancy and Early Childhood

COPE
Start date: June 2, 2020
Phase:
Study type: Observational [Patient Registry]

Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in the human race resulting in a world-spanning pandemic came as a surprise and at a tremendous cost both for individual human lives as well as for the society and the health care sector. The knowledge on how this new infection affects both the mother and the unborn child as well as the outcomes for the mother and the child in the long run are unknown. What is known is based on case-reports and small case-series solely. Both the coronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) can cause a threat to pregnant women and their offspring, which leads to the question whether this could be the case also for SARS-CoV-2. Aims: To establish a biobank of biological material from infected as well as non-infected pregnant women and their offspring. To combine this biobank with Swedish quality and health care registers, computerized patient charts and questionnaire data, enabling both short-term follow up, such as obstetric outcomes, as well as long-term outcomes both for mother and child. To study how the pandemic situation affects both the mother and her partner in their experience of pregnancy, childbirth, and early parenthood. Design: A national Swedish multicentre study. Women are included when they have a positive test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019 (COVID-19) (COVID-19 group). Pregnant women without COVID-19 symptoms will be included at their routine visits (Screening group). Blood samples and other biological material will be collected at different time-points. Additional predictors and outcomes are collected from the Swedish Pregnancy Register as well as obligatory Swedish health registers. The biobank and its linkage to health registers through the Swedish personal identification number will enable future research. Child development will be followed during the first year of life by questionnaires to the parents. Womens' and their partners' experience of childbirth and parenthood will be studied in form of questionnaires as well as in form of interviews. Conclusion: This project will help obstetricians and neonatologists better recognize clinical manifestations of the virus, identify possible risk factors during pregnancy and tailor therapies alongside providing right level of surveillance and management during pregnancy, delivery, and child health care.

NCT ID: NCT04400149 Not yet recruiting - Clinical trials for Pregnancy Complications

Progesterone Levels and Pregnancy Results

Start date: December 1, 2021
Phase:
Study type: Observational

The aim of this study is to evaluate the amniotic fluid and serum progesterone level and pregnancy outcome