CLINICAL TRIAL

CenteringPregnancy for Premature Birth

Low Risk
Waitlist Available · < 65 · Female · Clemson, SC

This study is evaluating whether CenteringPregnancy group prenatal care can improve preterm birth rate and other birth outcomes, maternal psychosocial and behavioral outcomes, and decrease the racial difference in selected birth outcomes among African American and White women, compared to individual

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About the trial for Premature Birth

Eligible Conditions
Premature Births · Pregnant State · Premature Birth

Treatment Groups

This trial involves 2 different treatments. CenteringPregnancy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
CenteringPregnancy
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CenteringPregnancy
2011
Completed Phase 3
~1100

Eligibility

This trial is for female patients aged 65 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must attend the intake screening visit before 20 6/7 weeks gestation in order to be randomized by 23 6/7 weeks gestation. show original
Pregnant women aged between 14-45 years
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Measured at delivery
Screening: ~3 weeks
Treatment: Varies
Reporting: Measured at delivery
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Measured at delivery.
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether CenteringPregnancy will improve 1 primary outcome and 6 secondary outcomes in patients with Premature Birth. Measurement will happen over the course of Measured at delivery.

Gestational weight gain
MEASURED AT DELIVERY
Weight gained during pregnancy as compared to medical recommendation
MEASURED AT DELIVERY
Gestational hypertension
MEASURED DURING PREGNANCY
Hypertension (SBP/DBP: above 140/90 mm Hg) occurred during pregnancy according to medical chart
MEASURED DURING PREGNANCY
Birth weight
MEASURED AT DELIVERY
Infant weight (in grams) a birth
MEASURED AT DELIVERY
APGAR score
MEASURED AT DELIVERY
Five criteria used to summarize the health of newborn children: Appearance, Pulse, Grimace, Activity, Respiration
MEASURED AT DELIVERY
Gestational diabetes incidence
MEASURED DURING PREGNANCY
Diabetes (occurred during pregnancy (two steps: 50-g GLT (nonfasting) with PG measurement at 1 h (Step 1), at 24-28 wks in women not previously diagnosed with overt diabetes If PG at 1 h after load is ≥140 mg/dL (7.8 mmol/L), proceed to 100-g OGTT (Step 2), performed while patient is fasting GDM diagnosis made when two or more PG levels meet or exceed: Fasting: 95 mg/dL or 105 mg/dL (5.3/5.8) hr: 180 mg/dL or 190 mg/dL (10.0/10.6) hr: 155 mg/dL or 165 mg/dL (8.6/9.2) hr: 140 mg/dL or 145 mg/dL (7.8/8.0)
MEASURED DURING PREGNANCY
Preterm birth
MEASURED AT DELIVERY
Delivery before 37 weeks gestation
MEASURED AT DELIVERY
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Who is running the study

Principal Investigator
M. H.
Moonseong Heo, Contact Principal Investigator
Clemson University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get premature birth a year in the United States?

Between 3.5 and 11 million Americans are born prematurely each year in the United States. Approximately one-tenth of them die in infancy or in early childhood.

Anonymous Patient Answer

What is premature birth?

Premature birth is a significant and growing public health issue encompassing both short-term as well as long-term complications, especially in the developing world. It is not only important to understand the mechanisms and epidemiologic associations of preterm birth, but also the effect of this public health problem on the human condition and the economic burden of prematurity.

Anonymous Patient Answer

What are common treatments for premature birth?

Multiple potential preventive strategies are available for premature birth. Although most of the available evidence on therapies for premature birth suggests little benefit, clinicians may need to be cautious in implementing these interventions. Future research needs to elucidate the optimal timing and duration of treatment and identify the potential effects of treatment on long-term deficits and functional outcomes.

Anonymous Patient Answer

What causes premature birth?

A complex interplay between genetics, infections, and environmental factors in pregnancy underlie premature birth. The premature birth risk is a dynamic and adaptable response to life's many demands and changes that are normally encountered in human pregnancy. This model provides a unifying link between the many and diverse, and seemingly unique, mechanisms underlying premature birth.

Anonymous Patient Answer

Can premature birth be cured?

Preterm delivery must not be construed as a disease entity, with possible adverse consequences for the infant. Preterm infants can remain in health if given appropriate management, avoiding potentially harmful maternal treatments to cure a "disease of the womb" in an advanced stage of development.

Anonymous Patient Answer

What are the signs of premature birth?

The signs of a premature birth can be ascertained by listening carefully to the mother's heartbeat, a hard or soft fetal sounds and the action and reaction of the infant.\n\nIt may be necessary to have a number of tests to establish the diagnosis of premature birth and the cause. This is mainly to see if there are any conditions that may relate to the timing of births during pregnancy.\n\nMost premature births are associated with premature rupture of membranes, or PROM. PROM is usually evident when the membranes between the amniotic sac and the cervix begin to break, releasing a small amount of amniotic fluid into the surrounding vagina.

Anonymous Patient Answer

What is the average age someone gets premature birth?

The mean maternal age at delivery is 34.2 years in Canada. The mean maternal age at birth for the Canadian population as a whole was estimated at 30.2 years. Since most women in Canada give birth later than 26 to 30 years of age, the prevalence of preterm birth rises in the age group over the age of 26–30 years. The prevalence of preterm births is increasing in women of Canadian Indian ancestry. Preterm birth is increasingly being diagnosed at much earlier ages in men (i.e., at the age of 20–25 years) compared with previous decades. Overall, Canadian birth rate is higher than the United States birth rate.

Anonymous Patient Answer

How does centeringpregnancy work?

Centeringpregnancy has been described as the most widely adopted intervention for decreasing the rate of LBW. Although its efficacy in decreasing the rate of LBW has been supported by multiple studies, its effects on maternal morbidity and mortality, fetal and childhood morbidity, and financial cost remain unknown. However, based on our analysis, we believe that centeringpregnancy has the ability to improve LBW and maternal and infant mortality, fetal and childhood morbidity, and financial costs. Given that centeringpregnancy may be more feasible in resource-developing settings, there is a need to conduct more research on centeringpregnancy's impacts.

Anonymous Patient Answer

Is centeringpregnancy typically used in combination with any other treatments?

The use of centeringpregnancy may be beneficial for high-risk patients if they are being informed about the potential risks and are willing to take part in the intervention.

Anonymous Patient Answer

Is centeringpregnancy safe for people?

The evidence from the published research indicates that centered pregnancies are not at increased risk of complications such as preterm birth, a low birthweight or intrauterine death. However, there are risks associated with centered pregnancy and every pregnancy. Therefore, each pregnancy must be evaluated individually.

Anonymous Patient Answer

What are the latest developments in centeringpregnancy for therapeutic use?

The current scientific literature supports the concept of centeringpregnancy. Results from a recent paper of a recently published study demonstrated the increased use of centeringpregnancy in the last decade (n=15,000; p<0.0001). The authors suggest that the improved treatment with centeringpregnancy does not result from an increased knowledge, experience, perception, or willingness to use this treatment; rather, it was an indirect result of a new scientific evidence.

Anonymous Patient Answer
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