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

NCT02334397 | Completed

• 1 other identifier: STU00095770
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Prenatal Exercise; Prenatal Education; Pregnancy; Exercise and Birth Outcomes; Education and Birth Outcomes; Maternal Quality of Life; Birth Satisfaction

Outcome Measures

Primary Outcomes (2)

• Predomination of type of birth, operative vaginal delivery versus natural spontaneous vaginal delivery

  We will be comparing the proportion of women who undergo operative vaginal delivery versus natural spontaneous vaginal delivery among pregnant women participating in an antepartum fitness and education program and women not participating in the program. We will do so using standard Delivery Information Forms and Northwestern University's Electronic Data Warehouse (EDW).

  At time of delivery (~6 months after baseline)

• Indication for operative vaginal delivery (if applicable)

  We will compare the indication for operative vaginal delivery among women who undergo operative vaginal deliveries. We will do so using standard Delivery Information Forms and Northwestern University's Electronic Data Warehouse (EDW).

  At time of delivery (~6 months after baseline)

Secondary Outcomes (7)

• Obstetrical Complications (using data from Northwestern's Electronic Data Warehouse)

  From time of delivery to 6 weeks Postpartum

• Level of worry/concern about the birthing experience (Penn State Worry Questionnaire)

  Baseline, at time of delivery, 6 weeks postpartum

• Knowledge about the birthing experience ( Birth Technology and Maternal Roles in Birth: Knowledge and Attitudes of Canadian Women Approaching Childbirth for the First Time Questionnaire)

  Baseline, at time of delivery, 6 weeks postpartum

• Pelvic Floor Symptoms (Pelvic Floor Distress Inventory)

  Baseline, at time of delivery, 6 weeks postpartum

• Sexual Function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)

  Baseline, at time of delivery, 6 weeks postpartum

Study Arms (2)

Total Control Program

ACTIVE COMPARATOR

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.

Behavioral: Total Control Program

Control Group

NO INTERVENTION

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.

Interventions

Total Control Program BEHAVIORAL

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

Total Control Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medical Group's Integrated Pelvic Health Program

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 32378735 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Christina Gaupp, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology, Associate Residency Program Director, Medical Director of PEAPOD clinic

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 8, 2015
• Study Start: February 1, 2016
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

US (1)