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| Tracking Information | |||||||||
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| First Received Date † | July 19, 2007 | ||||||||
| Last Updated Date | July 20, 2007 | ||||||||
| Start Date † | June 2006 | ||||||||
| Current Primary Outcome Measures † |
Post-operative pain [ Time Frame: Six weeks ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00505362 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † |
Post-operative adhesions [ Time Frame: Years: at time of repeat cesarean ] | ||||||||
| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title † | Pain Study of Rectus Muscle Closure at Cesarean Delivery | ||||||||
| Official Title † | Rectus Muscle Closure vs. Non-Closure at Primary Cesarean Delivery and Post-Operative Pain | ||||||||
| Brief Summary | Suture reapproximation of the rectus muscles at primary cesarean delivery is a common practice about which there are no data. Some Obstetricians believe that suture reapproximation of the rectus muscles increases post-operative pain, and it may decrease adhesions, yet there are no published data to support or refute these claims. The purpose of this study is to assess the effect of rectus muscle reapproximation at cesarean delivery and post-operative pain. We also plan to assess the impact of rectus muscle closure on adhesions as seen at repeat cesarean delivery. |
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| Detailed Description | There are more than 1 million cesarean deliveries performed annually in the United States, at a rate of 30.2% of all deliveries. Data are limited regarding optimal surgical closure techniques to minimize adhesions at cesarean. Adhesions are implicated in pelvic pain, infertility, difficult repeat surgery, and bowel obstruction. Practice techniques regarding rectus muscle reapproximation vary widely, and there are no data regarding the impact of this step on pain, and some data suggesting a reduction in significant adhesions. Given the frequency of cesarean deliveries, small changes in surgical technique may yield significant benefits. We hope to learn 1) whether suture reapproximation of the rectus muscles increases pain, and 2) the degree to which suture reapproximation of the rectus muscles alters adhesions when studied in a prospective, randomized trial. All patients undergoing primary cesarean delivery at LPCH will be offered the study. Once consented, patients will be randomized to one of two standardized closure techniques at cesarean: two-layer uterine closure, peritoneal closure, fascial and skin closure, and either reapproximation of the rectus muscles with three-interrupted sutures, or non-closure. Intra-operative and post-operative pain management will be standardized. Subjects will undergo pain assessments while in-house on post-operative days 1 and 3, and at the standard post-partum clinic visit after 6 weeks. These assessments will require less than 5 minutes of the patient's time. Patients will be shown a pain chart, and will be asked to rate their pain on a scale of 0 to 10 at rest. They will then stand up and rate their pain again. Pain medication usage will also be assessed. For patients who undergo repeat cesarean delivery, their surgeons will be asked to fill out a validated adhesion assessment form following surgery. We will not dictate the method of surgical technique at repeat cesarean, but will simply ask surgeons to describe the adhesions. At the time of consent, the patient will be asked to contact the study coordinator in the future should they undergo cesarean. In addition, the study coordinators will contact patients one-year after enrollment to inquire about plans for future pregnancies. The surgeons will know the groups to which the patients are randomized. The patients and those collecting data on pain scores will not. |
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| Study Phase | Phase II, Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Efficacy Study | ||||||||
| Condition † |
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| Intervention † | Procedure: Suture reapproximation of the rectus muscles | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 112 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00505362 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Stanford University | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Stanford University | ||||||||
| Verification Date | July 2007 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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