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临床试验/NCT07828275
NCT07828275尚未招募2 期

Adapting and Testing Behavioral Intervention to Prevent Fetal Alcohol Spectrum Disorders and Adverse Infant Outcomes (R33)

Philadelphia College of Osteopathic Medicine1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2027年2月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
尚未招募
入组人数
184
试验地点
1
主要终点
Urinalysis results for alcohol use

研究概览

简要总结

This R33 application proposes to adapt and test an evidence-based behavioral intervention to decrease polysubstance use (i.e., alcohol and tobacco/cannabis) during pregnancy and lactation and prevent adverse clinical outcomes, including fetal alcohol spectrum disorder (FASD) in South Africa (SA). SA has a long history of social and health disparities, resulting in the world's highest rate of FASD (111.1 per 1,000), where lifelong negative cognitive and physical effects result from prenatal alcohol exposure. FASD is completely preventable if women do not drink during pregnancy. Prenatal alcohol use frequently co-occurs with other substance use, especially tobacco and cannabis. The adverse effect on birth outcomes by alcohol and tobacco use together is worse than either substance alone. Recent evidence from animal models shows that prenatal exposure to both cannabinoids and alcohol potentiate the likelihood of alcohol-induced birth defects. Data from Cape Metropole, SA, showed that all women who reported prenatal alcohol use also tested positive for tobacco use, with 25% also reporting cannabis use. Alcohol use while breastfeeding also occurs at a relatively high rate in SA. Despite tremendous health benefits from breastfeeding, maternal alcohol use while breastfeeding significantly compromises infant development. Contingency management (CM) has been efficacious in reducing prenatal cocaine, alcohol, and tobacco use in the United States (U.S.). The Women's Health CoOp (WHC) is an evidence-based brief intervention addressing women-focused syndemic issues and resulting disparities associated with substance and alcohol use. These evidence-based interventions need to be combined and adapted for addressing maternal polysubstance use and associated health and behavioral issues during pregnancy and lactation in SA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • (1) be pregnant, (2) intend to breastfeed, (3) test positive for alcohol use by urinalysis (i.e., EtG), (4) test positive for tobacco or cannabis use by urinalysis (i.e., cotinine and THC), (5) have an independent access to a mobile phone, (6) plan to remain in the area during pregnancy and 3 months postpartum.

排除标准

  • Report serious medical problems threatening their current pregnancy or current suicidal thoughts or attempts in the past month.

研究组 & 干预措施

Usual Care

Active Comparator

Participants will receive community referrals to treatment programs as needed and will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample and fill out timeline follow-back. R200 will be provided for sample provision. Research staff will make referrals to treatment programs in the community as needed.

干预措施: Usual Care (Behavioral)

Intervention

Experimental

Participants will receive text-based support on health promotion and referral content based on educational components. Participants will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample, fill out timeline follow back on self-reported alcohol and tobacco/cannabis use, and receive contingent incentives if abstinence is verified.

干预措施: Intervention (Behavioral)

结局指标

主要结局

Urinalysis results for alcohol use

时间窗: From enrollment to the end of treatment at 3 months postpartum

An alcohol metabolite (EtG) will be measured in urine samples. EtG can be detected in the urine up to 5 days after heavy drinking and up to 2 days after light drinking with ≥150 ng/mL for EtG as a cutoff value.

Urinalysis results for tobacco use

时间窗: From enrollment to the end of treatment at 3 months postpartum

Biochemical verification of recent tobacco use in urine samples. A tobacco metabolite (cotinine) will be measured in urine samples. The metabolite can be detected up to 3-4 days after use with ≥ 80ng/mL as a cutoff.

Urinalysis results for cannabis use

时间窗: From enrollment to the end of treatment at 3 months postpartum

Biochemical verification of recent cannabis use in urine samples. A cannabis metabolite (THC) will be measured in urine samples. The metabolite can be detected up to 28 days after heavy use with ≥50 ng/mL as a cutoff.

次要结局

  • Head circumference(Birth)
  • Apgar score(Birth)
  • Birth weight(Birth)
  • Gestational age at birth(Birth)
  • NICU admission(Birth to 3 months postpartum)
  • Infant weight at 3 months(3 months postpartum)
  • Infant height at 3 months(3 months postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yukiko Washio

Research Assistant Professor

Philadelphia College of Osteopathic Medicine

研究点 (1)

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