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Effect of a prenatal program on child development among babies exposed to Covid-19 in utero

Exposure to SARS-Cov-2 and child development in the first year of life

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4bv89x8
Enrollment
Unknown
Registered
2024-09-21
Start date
2021-12-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Postpartum

Interventions

This is a two-arm, single-blind, randomized, controlled clinical study. Experimental group: 10 pregnant women followed in a high-risk prenatal center who received the virtual intervention during the t
E05.599.545

Sponsors

Instituto de Ensino e Pesquisa Alberto Santos Dumont
Lead Sponsor
Universidade Estadual de Campinas -UNICAMP
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria for both groups included singleton pregnancies followed at the Anita Garibaldi Health Center; minimum age 18 years; absence of confirmed or suspected fetal congenital infection or chromosomal anomalies; no serious illness or complications during pregnancy; and no substance use disorder

Exclusion criteria

Exclusion criteria: Failure to complete the follow-up during the first year after birth at the clinic; neonatal death; and extremely preterm (less than 28 weeks) or very preterm (less than 32 weeks) infants

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: impaired maternal-infant bonding at 4 months to be significantly lower in the intervention group.;Found outcome 1: Impairment in bonding at 4 months happened in 38.7% of the Control Group (CG), and 4.2% of the Intervention Group (IG) (p=.003).

Secondary

MeasureTime frame
Expected outcome 2: depression mean scores at 1 month and 4 months post-partum to be significantly lower in the intervention group. ;Found outcome 2: Depression mean scores at 1 month post-partum were significantly lower in the Intervention Group (7.8 vs. 13.1, p=.02). For the 4-month assessment there was no statistically significant difference.

Countries

Brazil

Contacts

Public ContactCarolina Araújo Damasio Santos

Instituto de Ensino e Pesquisa Alberto Santos Dumont

carolina.damasiosantos@gmail.com+55(84)3271-3311

Outcome results

None listed

Source: REBEC (via WHO ICTRP)