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This document outlines a protocol for a randomized controlled trial aimed at reducing risky drinking in pregnant women through brief interventions in antenatal care settings.
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How to fill out Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

01
Begin by reviewing the study objectives and background information regarding risky drinking in pregnancy.
02
Gather relevant participant information, including demographics and drinking history.
03
Develop a clear and concise intervention script to guide discussions with participants.
04
Create educational materials that outline the risks associated with alcohol consumption during pregnancy.
05
Train staff on the intervention protocol to ensure consistency and adherence to the study guidelines.
06
Schedule individual sessions with participants to deliver the intervention.
07
Collect baseline data before the intervention to evaluate its effectiveness later on.
08
Implement follow-up sessions to monitor changes in drinking behaviors and provide support.
09
Document all findings and participant feedback throughout the study.

Who needs Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial?

01
Pregnant individuals who engage in risky drinking behaviors.
02
Healthcare providers looking to implement interventions to support pregnant patients.
03
Researchers interested in understanding the effects of alcohol on pregnancy outcomes.
04
Organizations focused on maternal health and addiction prevention.
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Resources. If you are pregnant or trying to get pregnant and cannot stop drinking, get help! Contact your healthcare provider, local Alcoholics Anonymous, or local alcohol treatment center. The Substance Abuse and Mental Health Services Administration (SAMHSA) has a treatment facility locator.
Research shows that binge drinking and heavy drinking during pregnancy put a developing baby at the greatest risk for severe problems. However, even lesser amounts can cause harm. In fact, there is no known safe amount of alcohol consumption during pregnancy.
Alcohol use during pregnancy is associated with an increased risk of miscarriage, preterm birth, stillbirth, and sudden infant death syndrome (SIDS). Alcohol use during pregnancy can cause a range of lifelong behavioral, intellectual, and physical disabilities known as fetal alcohol spectrum disorders (FASDs).
Overall, the SR found that, compared with usual care or no intervention, psychosocial interventions were effective in increasing abstinence rates during pregnancy, and in reducing alcohol consumption in mothers.
This study found that fetuses exposed to alcohol earlier in gestation were associated with more severe and debilitating cognitive abnormalities than those with later exposure in pregnancy. Other animal studies evaluating the effects of a single binge drinking incident prenatally have shown fetal neurotoxic effects.

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It is a research study designed to evaluate the effectiveness of a brief intervention aimed at reducing alcohol consumption among pregnant women at risk of drinking during pregnancy.
Researchers and healthcare professionals involved in the trial are required to file this protocol, ensuring compliance with ethical and regulatory standards.
Filling out the protocol involves providing detailed information about the trial design, participant recruitment, intervention methods, and measurement of outcomes.
The purpose is to determine whether brief interventions can effectively reduce risky drinking behaviors in pregnant women, thereby improving health outcomes for both mothers and babies.
The protocol must report the study objectives, design, participant criteria, methods of intervention, expected outcomes, and ethical considerations.
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