MedTrace Logo

Bump on the Ball: Impact of a Prenatal Exercise & Education Program on Birth Outcomes & Maternal Quality of Life

NCT02334397 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-06-04

No results posted yet for this study

Summary

Operative vaginal delivery (with forceps or vacuums) is frequently performed secondary to maternal exhaustion, which leads to an inability to push effectively; 40% of operative vaginal deliveries at Prentice are for maternal exhaustion. The risk of severe birth trauma is increased three to four fold with operative delivery. This randomized, controlled trial will compare rates of operative vaginal delivery and severe birth trauma in two groups of women: (1) an intervention group who will participate in the antepartum Total Control® fitness and education program modified for pregnancy; and (2) a control group. Women will be recruited and followed from the second trimester until 6 weeks postpartum; all will complete validated questionnaires regarding their (1) level of worry and knowledge about their birthing experience (2) pelvic floor symptoms and quality of life (3) sexual function (4) satisfaction with their birthing experience and (5) level of depressive symptoms at various time points during and after their pregnancy. Obstetrical data will also be collected.

Conditions

  • Pregnancy

Interventions

BEHAVIORAL

Total Control Program

Women will be enrolled in Total Control, which is a fitness and education program.

Sponsors & Collaborators

Principal Investigators

  • Christina Gaupp, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-06-25
Completion
2019-06-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02334397 on ClinicalTrials.gov