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Preterm Birth clinical trials

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NCT ID: NCT04384328 Terminated - Preterm Birth Clinical Trials

Evaluation of an Early Support Programme in Orthophony

PAPEV-ortho
Start date: November 27, 2019
Phase: N/A
Study type: Interventional

Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study, to measure the impact of an early support programme in speech and language therapy for vulnerable children (PAPEV-ortho), in children born very prematurely or very hypotrophically, on the incidence of language and communication deficits at the corrected age of 2 years.

NCT ID: NCT04183452 Terminated - Preterm Birth Clinical Trials

17-OHPC in Pregnancy: IM vs SC Routes

Start date: June 16, 2020
Phase:
Study type: Observational

This study will compare the plasma concentration x time curve or Area Under the Curve (AUC) and the side effects reported with 250 mg intramuscular (IM) and 275 mg subcutaneous (SC) injections of 17-hydroxyprogesterone caproate (17-OHPC).

NCT ID: NCT03979196 Terminated - Preterm Birth Clinical Trials

Inpatient vs Outpatient Management of Short Cervix

Start date: June 6, 2019
Phase: N/A
Study type: Interventional

The presence of short cervix during pregnancy is a risk factor for preterm birth though in many cases women will eventually deliver at term or near term. While there are proven treatments such as cerclage and progesterone that can improve pregnancy outcomes, many women are advised to limit their activity, are put on bed rest, or admitted to hospital for inpatient management. Presently, there is no evidence that hospital admission of women with short cervix is beneficial and prolongs the pregnancy. The investigators propose to examine whether inpatient management results in comparable outcomes to outpatient management for women with short cervix.

NCT ID: NCT03921177 Terminated - Preterm Birth Clinical Trials

Micronutrient Supplementation Before and During 1st Pregnancy to Improve Birth Outcomes (JiVitA-5)

JiVitA-5
Start date: January 17, 2019
Phase: N/A
Study type: Interventional

The purpose of this cluster-randomized trial is to evaluate the efficacy of daily, multiple micronutrient (MM) supplement versus identical placebo use among nulligravid, recently married women, starting preconceptionally through the 1st trimester of pregnancy, in reducing low birth weight and other adverse pregnancy outcomes in rural Bangladesh.

NCT ID: NCT03863613 Terminated - Preterm Birth Clinical Trials

Pessary Versus Cerclage With or Without Progesterone in Twins

PCP-Twins
Start date: March 23, 2019
Phase: N/A
Study type: Interventional

This study compares the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone for prevention of preterm birth in women with a twin pregnancy and a cervix ≤28 mm. Participants will be randomly assigned in a 1:1:1:1 ratio to receive cerclage, pessary, cerclage plus progesterone or pessary plus progesterone.

NCT ID: NCT03715530 Terminated - Preterm Birth Clinical Trials

Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women

PAMG-1
Start date: September 2007
Phase: N/A
Study type: Interventional

The study is to evaluate the accuracy of a test device called "PAMG-1" to see if a pregnant women has ruptured membranes in comparison to standardly used testing methods.

NCT ID: NCT03543475 Terminated - Preterm Birth Clinical Trials

Cervical Pessary for Prevention of Spontaneous Preterm Birth in Singleton Pregnancies With Arrested Preterm Labor

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Different strategies have been studied for prevention of spontaneous PTB (SPTB) in randomized controlled trials (RCTs), including progesterone, cerclage, cervical pessary, as well as lifestyle modification, such as smoking cessation, diet, aerobic exercise, and nutritional supplements. Most successful effort to reduce the incidence of SPTB have focused on asympatomatic women with risk factors, such as prior SPTB or short cervix. However, most SPTB occur in symptomatic women, i.e. women with preterm labor (PTL). Women with arrested PTL are at increased risk of SPTB. The cervical pessary is a silicone device that has been used to prevent SPTB. The leading hypotheses for its mechanisms are two: that the pessary helps to keep the cervix closed, and that the pessary changes the inclination of the cervical canal so that the pregnancy weight is not directly above the internal os. The aim of the study is to assess the efficacy of pessary in reducing preterm birth in women with arrested preterm labor

NCT ID: NCT03530332 Terminated - Preterm Birth Clinical Trials

Prediction and Prevention of Preterm Birth (PREVENT-PTB Study)

Start date: May 14, 2018
Phase: N/A
Study type: Interventional

This research study is being done to find out whether a screening blood test can help identify women with an increased risk of preterm birth.

NCT ID: NCT03292731 Terminated - Preterm Birth Clinical Trials

Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth

PRO
Start date: February 12, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The study plans to determine the relationship between plasma concentrations of 17-OHPC hydroxyprogesterone caproate (17-OHPC) and the rate of preterm birth. The study is an open label study of pregnant women with one or more prior spontaneous preterm births who are receiving either 250mg of 500 mg of 17-OHPC as a weekly single injection. The safety of the 500 mg dose will also be assessed.

NCT ID: NCT02948192 Terminated - PreTerm Birth Clinical Trials

The Reproductive Microbiome & Perinatal Health Outcomes

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

Pregnant African American women between 18 and 45 years of age will be enrolled at 20 weeks of gestation or less. Biological specimens (vaginal swabs, rectal swab) will be collected at enrollment, 23-24 weeks, at 28-29 weeks, and at the onset of labor. A urine sample will be obtained at entry and at the time of delivery for metabolomic analysis. Participants will also collect a dietary survey at entry, 23-24 weeks, and 28-29 weeks. The biological specimens will then be analyzed for their microbiomial profile. This will then be correlated with the timing of their delivery as well as other comorbidities such as obesity, hypertension, and diabetes.