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Uterine Artery Ligation to Decrease Blood Loss With Central Placenta Previa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02002026
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmad Sameer Sanad, Minia Maternity University Hospital

Brief Summary:
This trial will address the effect of uterine artery ligation during Cesarean section in cases with placenta previa to decrease blood loss.

Condition or disease Intervention/treatment Phase
Placenta Previa Without Hemorrhage Procedure: Uterine artery ligation Not Applicable

Detailed Description:
This Study will address the effect of uterine artery ligation prior to fetal delivery during Cesarean section in cases with central placenta previa to guard against postpartum hemorrhage and to minimize blood loss.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Uterine Artery Ligation to Minimize Blood Loss in Patients With Central Placenta Previa
Study Start Date : November 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Ligation group
Uterine artery ligation will be done for patients in this group
Procedure: Uterine artery ligation
Uterine artery ligation during cesarean section before delivery of the baby

Placebo Comparator: Control group
Conventional CS
Procedure: Uterine artery ligation
Uterine artery ligation during cesarean section before delivery of the baby




Primary Outcome Measures :
  1. Changes in hemoglobin level [ Time Frame: hemoglobin level will be done baseline and will be repeated 24 hours after delivery ]
    Changes in hemoglobin level before and after CS will reflect the amount of blood loss during operation


Secondary Outcome Measures :
  1. Degree of uterine contractility. [ Time Frame: During CS and within 3 hours after CS ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasound
  • Symptomatic Placenta previa with at least one episode of bleeding
  • Estimated gestational age within 28 to 40 weeks
  • Maternal age > 18 years
  • Informed consent
  • Social affiliation

Exclusion Criteria:

  • Premature rupture of membranes
  • Severe bleeding.
  • Abnormal fetal heart rates.
  • Pre-eclampsia, chorioamnionitis, severe chronic renal disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002026


Locations
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Egypt
Minia Maternity University Hospital
Minia, Egypt, 61111
Sponsors and Collaborators
Minia Maternity University Hospital
Investigators
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Principal Investigator: Ahmad S Sameer, MD Minia Maternity University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahmad Sameer Sanad, Assistant Professor, Minia Maternity University Hospital
ClinicalTrials.gov Identifier: NCT02002026    
Other Study ID Numbers: U1111-1150-4666
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Keywords provided by Ahmad Sameer Sanad, Minia Maternity University Hospital:
placenta previa, uterine artery ligation
Additional relevant MeSH terms:
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Placenta Previa
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases