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PregnancyNCT02334397

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

A study of Pregnancy, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteUnited States
Study dates
Feb 2016to 25 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern Medical Group's Integrated Pelvic Health Program

    Chicago, Illinois, 60611

Other trials in United States

About this study

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.

Read the 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
Being tested
Total Control Program
Keywords
Prenatal Exercise, Prenatal Education, Pregnancy, Exercise and Birth Outcomes, Education and Birth Outcomes, Maternal Quality of Life, Birth Satisfaction
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Control ProgramBehavioural

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

Study groups in NCT02334397
Study groupRoleWhat they receive
Total Control ProgramActive comparatorWomen 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.
Receives: Behavioral: Total Control Program
Control GroupNo interventionThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: At time of delivery (~6 months after baseline)

  2. 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).

    Measured: At time of delivery (~6 months after baseline)

Secondary outcomes (7)

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

    We will be comparing both groups' obstetrical complications, including rates of severe perineal trauma or obstetrical anal sphincter lacerations and wound complications, among intervention and control groups. We will do so using data from Northwestern's Electronic Data Warehouse (EDW).

    Measured: From time of delivery to 6 weeks Postpartum

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

    Penn State Worry Questionnaire (PSWQ) scores will be compared among the groups to determine which group will have less worry/concern about their birthing experience.

    Measured: Baseline, at time of delivery, 6 weeks postpartum

  3. 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)

    Knowledge about the birthing experience will be compared between groups utilizing the Birth Technology and Maternal Roles in Birth: Knowledge and Attitudes of Canadian Women Approaching Childbirth for the First Time Questionnaire (KA)

    Measured: Baseline, at time of delivery, 6 weeks postpartum

  4. Pelvic Floor Symptoms (Pelvic Floor Distress Inventory)

    Baseline and postpartum pelvic floor symptoms will be compared between groups using the short form of the Pelvic Floor Distress Inventory (PFDI-SF).

    Measured: Baseline, at time of delivery, 6 weeks postpartum

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

    Baseline and postpartum sexual function will be compared between groups using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)

    Measured: Baseline, at time of delivery, 6 weeks postpartum

  6. Satisfaction with birthing experience (Satisfaction with Childbirth Rating Scale (SatCh) and Mackey Satisfaction with Childbirth Rating Scale)

    Satisfaction with the birthing experience will be compared among intervention and non intervention groups utilizing the Satisfaction with Childbirth Rating Scale (SatCh) and Mackey Satisfaction with Childbirth Rating Scale

    Measured: At time of delivery and during 6 weeks postpartum

  7. Postpartum Depression Incidence and Risk Factors ( Edinburgh Postnatal Depression Scale)

    Incidence of and risk factors for postpartum depression will be compared between groups using the Edinburgh Postnatal Depression Scale.

    Measured: 6 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completion25 Jun 2019
  4. Study completion25 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02334397
Sponsor's protocol ID
STU00095770
Status last verified
Jun 2020
First submitted
5 Jan 2015
Last updated
4 Jun 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32378735

Questions about this trial

What is this clinical trial studying?

A study of Pregnancy, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Predomination of type of birth, operative vaginal delivery versus natural spontaneous vaginal delivery (time frame: At time of delivery (~6 months after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02334397, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.

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