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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334397
• Other study ID #: STU00095770
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 25, 2019

Study information

• Verified date: June 2020
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 25, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern Medical Group's Integrated Pelvic Health Program	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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).	From time of delivery to 6 weeks Postpartum
Secondary	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.	Baseline, at time of delivery, 6 weeks postpartum
Secondary	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)	Baseline, at time of delivery, 6 weeks postpartum
Secondary	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).	Baseline, at time of delivery, 6 weeks postpartum
Secondary	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)	Baseline, at time of delivery, 6 weeks postpartum
Secondary	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	At time of delivery and during 6 weeks postpartum
Secondary	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.	6 weeks postpartum