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Obstetric Labor, Premature clinical trials

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NCT ID: NCT06350565 Not yet recruiting - Clinical trials for Respiratory Distress Syndrome of Newborn

A Clinical Pharmacological Study of Dose Halving of Dexamethasone in Pregnant Women With Preterm Labour With Preterm Birth at Greater Than or Equal to 34 Gestational Weeks (34GW+)

Start date: April 30, 2024
Phase: N/A
Study type: Interventional

This study plans to conduct a DEX dose halving study and a normal dose study in 34+0-35+6 GW women with preterm preterm labour. In addition, this study plans to conduct a DEX dose halving study and a normal dose study in 34-38+6 GW preterm pregnant women with GDM or diabetic co-pregnancy to explore the feasibility of dose halving in pregnant women with diabetes mellitus.

NCT ID: NCT06302023 Not yet recruiting - Clinical trials for Pregnant Women Diagnosed With Threatened Preterm Labor

Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor

Start date: March 1, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to learn about the effects of Docosahexaenoic acid (DHA) in reducing the incidence of premature birth in threatened preterm labor The main questions it aims to answer are: - Can DHA supplementation reduce the incidence of premature birth in threatened preterm labor? - How does DHA supplementation affect pregnancy outcomes? Participants were organized into two groups - Group 1 (Intervention) Participants will be asked to take a DHA 1000mg per day - Group 2 (control) Participant will not need to take a DHA

NCT ID: NCT06190496 Not yet recruiting - Preterm Labor Clinical Trials

Cervical Volume and Prediction of Preterm Labor

Start date: January 20, 2024
Phase:
Study type: Observational

The primary aim of this research is to assess the predictive value of 3D cervical volume and 3D power Doppler indices in predicting pregnancies at risk of preterm labor. Secondary aim: to compare 2D cervical length and 3D cervical length in coronal view for predicting preterm labour.

NCT ID: NCT05971654 Not yet recruiting - Preterm Labor Clinical Trials

Effect Of Azithromycin in Women at Risk of Preterm Labour

Start date: July 30, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to evaluate the benefit of the addition of azithromycin to standard treatments to prolong pregnancy in women having intact membranes and is at risk of or in preterm labour.

NCT ID: NCT05864066 Not yet recruiting - Preterm Labor Clinical Trials

Cyclin-dependent Kinase Inhibitor 2A (Placental Senescence Marker) on Labor-related Signals

Start date: September 2023
Phase:
Study type: Observational

Onset of labor in human is initiated by progesterone withdrawal. Over many decades researchers had proposed hypotheses to explain the functional withdrawal of progesterone. These hypotheses were through the sequestration of active progesterone by corticosteroid-binding globulin, a decrease in active progesterone metabolite levels and changes in the ratio of progesterone receptor (PR) isoforms (nuclear progesterone receptors A (nPRA) and nuclear progesterone receptors B (nPRB)). Progesterone performs its action non-genomically through binding to membrane receptors and genomically via binding to nPRs. PRA is the less active or inactive form of progesterone receptors and shorter in amino acid sequence than PRB, the active form of the receptors.

NCT ID: NCT05469984 Not yet recruiting - Clinical trials for Preterm Labor With Preterm Delivery

Comparing Two Prophylactic Antibiotic Protocols in Women With Term Prolonged Pre-labor Rupture of Membrane and Preterm Labor

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

This randomized prospective trial aimed to compare 2 prophylactic antibiotic regiment (ampicillin alone versus ampicillin plus gentamycin) in term prolonged pre-labor rupture of membrane and in preterm deliveries and examine related obstetrical outcome and infectious morbidity

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: NCT05044143 Not yet recruiting - Clinical trials for Preterm Labor With Preterm Delivery

Prediction of Preterm Delivery With Serial Cervical Length Measurements After Threatened Preterm Labor

Start date: September 20, 2021
Phase:
Study type: Observational

Prospective cohort study on pregnant women discharged from the hospital after the first episode of threatened preterm labor. Cervical length (CL) will be measured with transvaginal US upon initial presentation (i.e at the time of hospital admission), at the time of hospital discharge, and respectively 2, 4, 8 and 12 weeks later. Pregnant women undelivered after the 1st episode of threatened preterm labor will be invited to participate in the study if CL upon discharge is < 25 mm. The study will investigate the potential association between cervical shortening over time and time of delivery, to assess if spontaneous preterm delivery can be predicted by CL.

NCT ID: NCT04878978 Not yet recruiting - Clinical trials for Threatened Preterm Labor

Premature Rupture Membranes and tPTL: a Personalised Approach (PROMPT)

PROMPT
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Preterm birth (less than 37 weeks) affect approximately 8% of babies in the UK and is the worldwide leading cause of death in children under the age of 5. Subclinical infection affects approximately 50% of women giving birth before 32 weeks. Infection contributes to significant neonatal morbidity and mortality. Antibiotics such as erythromycin is currently used to treat women who present with preterm rupture of membranes. While this has shown short-term improvement in neonatal morbidity, it has not had any impact in reducing the perinatal mortality and also little effect on the health of the children at age seven. Some antibiotics such as co-amoxiclav has not shown to be effective in delaying delivery and some studies have shown that antibiotics increases rather than reduces the risk of cerebral palsy. Many women do not display signs of infection and the underlying bacteria is multifactorial (bacterial vaginosis, trichomoniasis, gonorrhoea, Chlamydia, ureaplasma, Group B streptococcal and E. Coli) and remains a diagnostic challenge. The only available clinical approach is to test the sample of amniotic fluid for bacteria and small case series have shown prolongation of pregnancy when accurately targeted antibiotic treatment is used. This research aims to prove that targeted antibiotic therapy results in a greater prolongation of pregnancy than standard management for women with preterm prelabour rupture of membranes (PPROM) and/or threatened preterm labour (tPTL). Women will be randomised to standard care versus BioFire directed antibiotic treatment in addition to standard care. Investigators will use the BioFire point of care testing to identify the presence of infection and identify with anti-microbial resistance genes the bacteria possess to guide the antibiotic treatment. To be certain that the presence of infection is detected the investigators will use PCR to test the amniotic fluid for IL-6 and white cell count.

NCT ID: NCT04644354 Not yet recruiting - Preterm Birth Clinical Trials

The Efficacy of Nifedipine in the Management of Preterm Labor

BOG/TH/PTL
Start date: December 15, 2020
Phase:
Study type: Observational

Preterm labor is one of the problems of obstetrics, and is one of the leading cause of neonatal morbidity and mortality. The incidence of preterm birth is around 7 to 9 %. The preterm baby is prone to respiratory, renal, neurologic and gastrointestinal problems. The correct diagnosis should be followed by the early administration of the most effective tocolytic agent with least side effects for both mother and fetus. Nifedipine, a calcium channel blocker, has gained a world-wide popularity recently since it has the least side-effects on both mother and fetus. In the present study, we aimed to evaluate the success rate of tocolytic agent 'nifedipine' on the spontaneous preterm labor of singeton pregnant women with intact amnionic membrane.