What is the mechanism of action of this treatment?

Common treatments for pregnancy complications include structured antepartum exercise programs and continuous fetal monitoring. Structured exercise programs help reduce the duration of labor stages and the need for medical interventions by improving physical fitness and reducing stress. Continuous fetal monitoring ensures the well-being of the fetus during labor, allowing for timely medical interventions if necessary. These treatments are crucial as they promote a healthier, more natural labor process and reduce the risk of complications, thereby improving outcomes for both the mother and the baby.

What side effects are associated with this type of intervention?

Common treatments for pregnancy complications that promote physical activity and stress reduction, such as structured exercise programs, generally show no adverse effects on fetal well-being. These programs can lead to shorter labor stages and reduced need for labor augmentation. However, treatments like low-dose aspirin, used for preventing pregnancy loss, may increase the risk of vaginal bleeding. Non-pharmacological interventions for labor pain management, such as aromatherapy and acupressure, are considered safe and effective. Overall, while promoting physical activity and stress reduction in pregnancy is beneficial, it is essential to monitor for specific side effects like increased bleeding risk with certain medications.

What prior FDA approvals exist?

The FDA has approved various treatments for pregnancy complications, though specific approvals for wrist-based activity trackers to reduce stress are not documented. Generally, treatments for pregnancy complications include medications like magnesium sulfate for preterm labor and neuroprotection, and interventions for conditions such as gestational diabetes and preeclampsia. These treatments aim to manage symptoms and improve maternal and fetal outcomes. The use of physical activity and stress reduction interventions, such as the wrist-based activity tracker, represents a novel approach that aligns with broader efforts to enhance prenatal care through lifestyle modifications.

What other types of research exist?

Promising, novel alternatives to wrist-based activity trackers for promoting physical activity and monitoring to reduce stress in pregnant women at high risk for complications include: 1) Smartphone applications with personalized activity and stress management programs, 2) Smart clothing with integrated sensors for continuous monitoring of physical activity and physiological parameters, 3) Virtual reality (VR) programs designed for stress reduction and guided physical activity, and 4) Telehealth platforms offering real-time feedback and support from healthcare providers.

← Back to Search

Behavioral Intervention

Activity Intervention for Pregnancy Stress (STEP Trial)

N/A

Waitlist Available

Led By Tracy A Manuck, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Maternal age 18 to 51 years of age

Ability to communicate in and provide consent in English

Must not have

Women pregnant with multifetal gestations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a smartphone-based activity intervention using a wrist-based activity tracker can help high risk pregnant women reduce their stress during pregnancy.

Who is the study for?

This trial is for pregnant women at high risk of complications due to obesity or past issues like preeclampsia, with a stress score ≥14. They must be 8-19.9 weeks along in a single pregnancy without abnormalities, aged 18-51, speak English, and own a compatible smartphone.

What is being tested?

The study tests if using a wrist-based activity tracker and receiving enhanced counseling can reduce stress and improve outcomes during pregnancy compared to standard care. Participants will fill out questionnaires and provide blood samples for analysis.

What are the potential side effects?

There are no direct side effects from the intervention as it involves non-invasive tracking of activity levels. However, participants should consult their doctor if they have conditions that limit physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman aged between 18 and 51.

Select...

I can communicate and consent in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am pregnant with more than one baby.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of women with adverse perinatal outcomes

Reduction in Perceived Maternal Stress

Secondary study objectives

Gestational weight gain

Gestational weight gain, per week after study enrollment

Mean 'Moderate' or greater physical activity

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Activity InterventionExperimental Treatment1 Intervention

Women randomized to this group will receive detailed information and reminders about physical activity and sleep in pregnancy. .

Group II: Usual careActive Control1 Intervention

Women randomized to this group will receive no guidance regarding exercise / activity / sleep during pregnancy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Activity Intervention

2014

Completed Phase 2

~90

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pregnancy complications include structured antepartum exercise programs and continuous fetal monitoring. Structured exercise programs help reduce the duration of labor stages and the need for medical interventions by improving physical fitness and reducing stress. Continuous fetal monitoring ensures the well-being of the fetus during labor, allowing for timely medical interventions if necessary. These treatments are crucial as they promote a healthier, more natural labor process and reduce the risk of complications, thereby improving outcomes for both the mother and the baby.

Continuous fetal monitoring in the ambulant patient in labour.Effect of a structured antepartum exercise program on pregnancy and labor outcome in primiparas.Reanalysis of a multireported trial on home uterine activity monitoring.