Skip to main content
OpenTrials
Completed

NCT Number: NCT02334397

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Behavior Motor Activity

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Medical Group's Integrated Pelvic Health Program

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Control Program

Behavioral

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

Primary outcomes

  1. Predomination of type of birth, operative vaginal delivery versus natural spontaneous vaginal delivery

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

    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).

  2. Indication for operative vaginal delivery (if applicable)

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

    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).

Secondary outcomes

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

    Time frame: From time of delivery to 6 weeks Postpartum

    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).

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

    Time frame: Baseline, at time of delivery, 6 weeks postpartum

    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.

  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)

    Time frame: Baseline, at time of delivery, 6 weeks postpartum

    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)

  4. Pelvic Floor Symptoms (Pelvic Floor Distress Inventory)

    Time frame: Baseline, at time of delivery, 6 weeks postpartum

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

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

    Time frame: Baseline, at time of delivery, 6 weeks postpartum

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

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

    Time frame: At time of delivery and during 6 weeks postpartum

    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

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

    Time frame: 6 weeks postpartum

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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 8, 2015
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.