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

NCT ID: NCT02334397

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2019-06-25

Brief 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.

Detailed Description

This will be a randomized controlled trial of primiparous women with singleton pregnancies who plan on delivering at Prentice Women's Hospital. Women will be recruited during their first trimester by their obstetrician as well as through standardized Northwestern Memorial Hospital flyers and ads. Demographic and delivery information will be obtained from the Northwestern Enterprise Data Warehouse (EDW), as well as by the attending midwife or physician at the time of delivery using a standardized Delivery Information Form. Women will also be asked about their other physical activities (including other forms of daily/weekly exercise) as well as whether or not they are participating in other birthing classes at the time of their first Total Control class (intervention group) or 2nd trimester visit with their providers (controls). All women will wear pedometers to track daily general activity.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Total Control Program

Women will be enrolled in Total Control, which is a fitness and education program. Specifically, Total Control is a comprehensive pelvic fitness and wellness program designed by board-certified female pelvic medicine and reconstructive surgery (FPMRS) practitioners as well as physical therapists that combines pelvic floor and core muscle strengthening. Subjects will participate in 1 standardized class per week during their second trimester for a total of 6 weeks. Women will also participate in a weekly educational session which will include keynote speakers who are experts in various aspects of the labor and delivery process. Women in this group will complete questionnaires and consent to use of their delivery outcomes. Women will also wear pedometers to track daily general activity.

Group Type: ACTIVE_COMPARATOR

Total Control Program

Intervention Type: BEHAVIORAL

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

Control Group

This group will consist of eligible women who were not randomized to the fitness and education program. Participants will complete questionnaires and consent to use of their delivery outcomes. Women will also wear pedometers to track daily general activity.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Total Control Program

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Singleton, primiparous pregnancy
• Delivering at Prentice Women's Hospital
• Able to participate based on PARmedX for pregnancy criteria

Exclusion Criteria

• Non-english or Spanish speaking
• Age less than 18 years
• Known condition requiring cesarean section
• Currently enrolled in any kind of physical therapy
• Unable to complete the program secondary to medical limitations

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Christina Lewicky-Gaupp

Assistant Professor of Obstetrics and Gynecology, Associate Residency Program Director, Medical Director of PEAPOD clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina Gaupp, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Medical Group's Integrated Pelvic Health Program

Chicago, Illinois, United States

Countries

United States

References

Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.

Reference Type: DERIVED

PMID: 32378735 (View on PubMed)

Other Identifiers

STU00095770

Identifier Type: -

Identifier Source: org_study_id