Bump on the Ball: Impact of a Prenatal Exercise & Education Program on

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Pregnancy

Clinical Trial Details

NCT number	NCT02334397
Study type	Interventional
Source	Northwestern University
Contact
Status	Completed
Phase	N/A
Start date	February 2016
Completion date	June 25, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03442582` - Afluria Pregnancy Registry
Terminated	`NCT02161861` - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study	N/A
Not yet recruiting	`NCT05934318` - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)	N/A
Enrolling by invitation	`NCT05415371` - Persistent Poverty Counties Pregnant Women With Medicaid	N/A
Completed	`NCT04548102` - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman	N/A
Completed	`NCT03218956` - Protein Requirement During Lactation	N/A
Completed	`NCT02191605` - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy	N/A
Completed	`NCT02223637` - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting	`NCT06049953` - Maternal And Infant Antipsychotic Study
Completed	`NCT02577536` - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting	`NCT06336434` - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy	Phase 1/Phase 2
Not yet recruiting	`NCT04786587` - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting	`NCT05412238` - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months	N/A
Not yet recruiting	`NCT05028387` - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed	`NCT02683005` - Study of Hepatitis C Treatment During Pregnancy	Phase 1
Completed	`NCT02783170` - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women	Phase 4
Recruiting	`NCT02507180` - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting	`NCT02564250` - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women	N/A
Recruiting	`NCT02619188` - Nutritional Markers in Normal and Hyperemesis Pregnancies	N/A
Completed	`NCT02379728` - Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms