Balloon Catheters in Cases of Abnormal Placentation (Accreta)
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Purpose
Placenta accreta is a relatively rare event, in which the placenta is abnormally implanted into the uterine myometrium. The most significant complication is intense bleeding, mainly during labor. The most important risk factors are previous cesarean delivery, placenta previa, and advanced maternal age. Cesarean hysterectomy is the recommended management. During the recent years, inserting intravascular balloon catheter for occlusion and/or arterial embolization, was introduced as an adjuvant therapy in order to minimize blood loss during cesarean hysterectomy or in conduct with conservative management with the intent of avoiding hysterectomy in selective cases. Contradicting reports exist regarding the effectiveness and safety of the catheters in cases of placenta accreta. The objective of this study is to estimate the efficacy of the balloon catheters among women diagnosed with a placenta accreta.
| Condition | Intervention |
|---|---|
|
Post Partum Bleeding |
Procedure: internal iliac catheterization |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Balloon Catheter for Occlusion of the Pelvic Vasculature as an Adjuvant Therapy in Cases of Placenta Accreta |
- Number of blood products transfused [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Need for hysterectomy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- catheter`s side effects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Length of hospitalization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 16 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: internal iliac catheterization
Women in this arm will undergo internal iliac artery catheterization prior to the cesarean delivery
|
Procedure: internal iliac catheterization
Women in this arm will undergo internal iliac artery catheterization prior to the cesarean delivery
Other Name: internal iliac artery catheterization
|
|
No Intervention: No intervention
no intervention prior to cesarean
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- pregnant women age 18-45
- antepartum diagnosis of placenta accreta
Exclusion Criteria:
- women who refuse to participate
Contacts and Locations| Israel | |
| Haemek Medical Center | Recruiting |
| Afula, Israel | |
| Contact: Raed Salim, MD 97246494355 salim_ra@clalit.org.il | |
| Contact: Gali Garmi, MD 97246494355 galit_ga@clalit.org.il | |
| Principal Investigator: Raed Salim, MD | |
| Principal Investigator: | Raed Salim | Dep. OB/GYN, HaEmek Medical Center, Afula, Israel |
More Information
No publications provided
| Responsible Party: | Raed Salim, MD, HaEmek Medical Center, Israel |
| ClinicalTrials.gov Identifier: | NCT01373255 History of Changes |
| Other Study ID Numbers: | 0043-08-EMC, Acreta02 |
| Study First Received: | June 10, 2011 |
| Last Updated: | March 19, 2013 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by HaEmek Medical Center, Israel:
|
Placenta accreta Internal iliac artery catheterization Post partum bleeding |
Additional relevant MeSH terms:
|
Hemorrhage Placenta Accreta Postpartum Hemorrhage Pathologic Processes Obstetric Labor Complications |
Pregnancy Complications Placenta Diseases Puerperal Disorders Uterine Hemorrhage |
ClinicalTrials.gov processed this record on June 17, 2013