60 Participants NeededMy employer runs this trial

Doula Support for Premature Birth

AH
SS
Overseen BySarbattama Sen, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Women and Infants Hospital of Rhode Island
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a community doula (a trained support person) can help reduce stress for families with a baby in the Neonatal Intensive Care Unit (NICU). Families will either receive traditional care or be paired with a doula who provides enhanced support, including weekly visits, for six weeks. The goal is to determine if this extra support can improve stress management. Families with babies in the NICU at Women and Infants Hospital, who are expected to stay for at least two weeks and speak English or Spanish, are well-suited for this trial. As an unphased trial, this study offers families the chance to contribute to understanding how additional support can enhance stress management during a challenging time.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that enhanced doula support is safe for families with a baby in the NICU?

Research has shown that extra support from a doula is generally safe and well-received. Studies have found that involving a doula in care during pregnancy and childbirth often leads to better outcomes. For instance, mothers with doula support tend to experience fewer cesarean sections and easier deliveries.

Other research indicates that women with doula care are less likely to give birth prematurely (before 37 weeks of pregnancy) and have babies with low birth weight. This suggests that doula support can lead to healthier pregnancies and births.

Regarding safety, studies reviewed report no negative effects linked to doula support. This indicates that having a doula is not only beneficial but also safe for both mothers and their babies.12345

Why are researchers excited about this trial?

Researchers are excited about the enhanced doula support for premature births because it offers personalized, one-on-one care specifically designed for families with babies in the Neonatal Intensive Care Unit (NICU). Unlike standard care, which primarily focuses on medical treatment, this approach includes a dedicated postpartum NICU doula who provides weekly support for six weeks, reinforcing health education and addressing medical, mental health, and social needs. This holistic and intensive engagement aims to improve overall family well-being and ensure that families have access to the necessary resources and support systems.

What evidence suggests that enhanced doula support is effective for reducing stress in families with a baby in the NICU?

Research has shown that having a doula can lower stress for families with a baby in the Neonatal Intensive Care Unit. In this trial, participants in the enhanced doula support arm will receive one-on-one support from a dedicated postpartum NICU doula. Studies have found that doula support can lead to better outcomes for mothers and babies, such as fewer early births and fewer delivery complications. Those who work with doulas also report feeling less stressed and experiencing better mental health. Additionally, having a doula is linked to greater satisfaction with the birth experience. These findings suggest that a doula might help families feel less stressed during this challenging time.12678

Are You a Good Fit for This Trial?

This trial is for parents or guardians of babies admitted to the NICU at Women and Infants Hospital, who expect their baby will stay in the NICU for at least two weeks. Participants must speak English or Spanish.

Inclusion Criteria

* baby admitted to NICU at Women and Infants Hospital
* anticipated NICU stay greater than or equal to 2 weeks
I can speak English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline surveys and physical assessments, including blood pressure and blood sample collection

1 week
1 visit (in-person)

Treatment

Participants receive enhanced doula support with weekly meetings for six weeks

6 weeks
6 visits (in-person)

Follow-up

Participants are monitored for stress, anxiety, depression, and other health outcomes

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced doula support

Trial Overview

The study tests whether weekly support from a community doula helps reduce stress in families with a baby in the NICU, compared to standard care. Families are randomly assigned to either receive doula support or not over six weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced doula supportExperimental Treatment1 Intervention
Group II: Standard CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials
119
Recruited
59,200+

Citations

The Effect of Doulas on Maternal and Birth Outcomes - PMC

Doula care in perinatal care was significantly correlated with positive delivery outcomes including reduced cesarean and premature deliveries.

Doula Care and Health Outcomes: A Systematic Review

This systematic review assesses the evidence base for understanding how doula programs can equitably and sustainably improve maternal-child ...

Role of doulas across the pregnancy care continuum on ...

Five studies have shown a reduced rate of preterm birth with doula support. For several studies, approximately 5% of women gave birth before ...

Do doulas improve labor and delivery outcomes ...

Compared with standard of care, the doula support group resulted in a significantly lower odds of preterm delivery (adjusted odds ratio [aOR] 0.43; 95% CI, 0.29 ...

Doula Care Improves Health Outcomes, Reduces Racial ...

Research shows that people who work with a doula throughout the prenatal period and childbirth are less likely to have a preterm delivery or a ...

Enhanced Doula Support to Improve Pregnancy Outcomes ...

This article is a meta-analysis of studies examining the influence of doula support on birth outcomes among African American women with disabilities.

Impact of Doulas on Healthy Birth Outcomes

Doula-assisted mothers were four times less likely to have a low birth weight (LBW) baby, two times less likely to experience a birth complication involving ...

Improved Mental Health Outcomes Associated with Doula ...

Doula care is associated with improved pregnancy outcomes, reduced cesarean rates, and enhanced breastfeeding success. Women receiving doula support show ...