Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Pregnancy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: This intervention examines whether the use of a fetal Doppler monitor, texted attachment exercises, or both interventions concurrently effectively increase maternal prenatal bonding.Masking: Double (Care Provider, Outcomes Assessor)Masking Description: Due to the behavioral design of the intervention, it is impossible to mask participants (who are asked to do tasks) or investigators (who train participants and contact them about tasks). However, care providers are not involved in the study, and the lab testing saliva samples will be masked.Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

Unintended pregnancy (unwanted and/or mistimed pregnancy) heightens the risk for adverse birth outcomes, including preterm birth and very low birth weight (< 1500 grams), which have significant public health costs. Despite decades spent attempting to reduce the proportion of pregnancies that are uni...

Unintended pregnancy (unwanted and/or mistimed pregnancy) heightens the risk for adverse birth outcomes, including preterm birth and very low birth weight (< 1500 grams), which have significant public health costs. Despite decades spent attempting to reduce the proportion of pregnancies that are unintended, nearly half (45%) of all pregnancies are unintended. Among women living in poverty, rates of unintended pregnancy are considerably higher. In this study, investigators focus instead on the reduction of a risky maternal health practice associated with adverse birth outcomes that are more common when pregnancies are unintended: maternal prenatal smoking. The study focuses on rapidly increasing maternal-fetal bonding, a mediator of the relationship between unintended pregnancy and maternal health practices during pregnancy, through a recently piloted intervention, BLOOM (Babies and Moms, connected by Love, Openness, and Opportunity). Specifically, the investigators will examine change in maternal-fetal bonding across pregnancy and implications for change in maternal smoking during pregnancy. The proposed study will use a randomized clinical trial design in a longitudinal, multi-ethnic cohort study of 160 predominately low-income women (ages 18 or older) who are 12-16 weeks pregnant and planning to continue their pregnancies and be primary caregivers to their infants. Participants will be randomly assigned into one of four groups for the intervention; the control group will receive treatment as usual. Participants assigned to one of the three treatment groups will either receive fetal Doppler monitors to listen to their babies' heartbeats for one minute per day over a two-week period; receive texted attachment exercises; or will be assigned to both interventions. Participants will complete an in-depth initial assessment that includes sociodemographic measures as well as a battery to capture maternal-fetal bonding and self-reported smoking. Participants will also be asked for a saliva sample for biochemical validation of smoking via cotinine levels, a biomarker for nicotine. The 2-week intervention will be conducted within two weeks following Assessment 1. Participants will then be asked to complete a follow-up survey and saliva assessment near the beginning of their 3rd trimester to assess maternal-fetal bonding and smoking to allow for examination of change across pregnancy. Impacts of prior interventions to reduce unintended pregnancy and its associated adverse infant outcomes have been modest; reducing the negative association between unintended pregnancy and adverse outcomes through enhancing maternal prenatal attachment makes this project highly significant. This project will be the first to target maternal-fetal bonding through the use of inexpensive fetal Doppler monitors, making it highly innovative. The positive impacts of this work include information that will be used to reduce the impact of unintended pregnancy for adverse infant health outcomes.

Tracking Information

NCT #
NCT04158089
Collaborators
Oklahoma Center for the Advancement of Science and Technology
Investigators
Principal Investigator: Karina M Shreffler, PhD Oklahoma State University