Clinical trial NCT02334397: Bump on the Ball: Impact of a Prenatal Exercise & Education Program on Birth Outcomes & Maternal Quality of Life
Official title: Bump on the Ball: Impact of a Prenatal Exercise & Education Program on Birth Outcomes & Maternal Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Prenatal Exercise
Prenatal Education
Pregnancy
Exercise and Birth Outcomes
Education and Birth Outcomes
Maternal Quality of Life
Birth Satisfaction
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Predomination of type of birth, operative vaginal delivery versus natural spontaneous vaginal delivery
timeFrame: At time of delivery (~6 months after baseline)
measure: Indication for operative vaginal delivery (if applicable)
timeFrame: At time of delivery (~6 months after baseline)
Secondary outcomes:
measure: Obstetrical Complications (using data from Northwestern's Electronic Data Warehouse)
timeFrame: From time of delivery to 6 weeks Postpartum
measure: Level of worry/concern about the birthing experience (Penn State Worry Questionnaire)
timeFrame: Baseline, at time of delivery, 6 weeks postpartum
measure: 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)
timeFrame: Baseline, at time of delivery, 6 weeks postpartum
measure: Pelvic Floor Symptoms (Pelvic Floor Distress Inventory)
timeFrame: Baseline, at time of delivery, 6 weeks postpartum
measure: Sexual Function (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
timeFrame: Baseline, at time of delivery, 6 weeks postpartum
measure: Satisfaction with birthing experience (Satisfaction with Childbirth Rating Scale (SatCh) and Mackey Satisfaction with Childbirth Rating Scale)
timeFrame: At time of delivery and during 6 weeks postpartum
measure: Postpartum Depression Incidence and Risk Factors ( Edinburgh Postnatal Depression Scale)
timeFrame: 6 weeks postpartum
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medical Group's Integrated Pelvic Health Program
state: Illinois
Study officials:
affiliation: Northwestern University
name: Christina Gaupp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.