Chicago, Illinois 60611


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02334397


Primary Contact:

Principal Investigator
Christina Gaupp, MD
Northwestern University

Christina Gaupp, MD
Phone: 312-472-3874
Email: cgaupp@nmff.org


Backup Contact:

Email: meera.tavathia@nm.org
Meera Tavathia
Phone: 312-926-7846


Location Contact:

Chicago, Illinois 60611
United States

Meera Tavathia
Phone: 312-926-7846
Email: meera.tavathia@nm.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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