Uterine Artery Ligation to Decrease Blood Loss With Central Placenta Previa
Uterine Artery Ligation to Minimize Blood Loss in Patients With Central Placenta Previa
1 other identifier
interventional
52
1 country
1
Brief Summary
This trial will address the effect of uterine artery ligation during Cesarean section in cases with placenta previa to decrease blood loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
December 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedMarch 16, 2016
March 1, 2016
1 year
November 18, 2013
March 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in hemoglobin level
Changes in hemoglobin level before and after CS will reflect the amount of blood loss during operation
hemoglobin level will be done baseline and will be repeated 24 hours after delivery
Secondary Outcomes (1)
Degree of uterine contractility.
During CS and within 3 hours after CS
Study Arms (2)
Ligation group
ACTIVE COMPARATORUterine artery ligation will be done for patients in this group
Control group
PLACEBO COMPARATORConventional CS
Interventions
Uterine artery ligation during cesarean section before delivery of the baby
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Premature rupture of membranes
- Severe bleeding.
- Abnormal fetal heart rates.
- Pre-eclampsia, chorioamnionitis, severe chronic renal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Minia Maternity University Hospital
Minya, Minya Governorate, 61111, Egypt
Related Publications (1)
Sanad AS, Mahran AE, Aboulfotouh ME, Kamel HH, Mohammed HF, Bahaa HA, Elkateeb RR, Abdelazim AG, El-Din MAZ, Shawki HE. The effect of uterine artery ligation in patients with central placenta pevia: a randomized controlled trial. BMC Pregnancy Childbirth. 2018 Aug 29;18(1):351. doi: 10.1186/s12884-018-1989-5.
PMID: 30157787DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmad S Sameer, MD
Minia Maternity University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 18, 2013
First Posted
December 5, 2013
Study Start
November 1, 2013
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
March 16, 2016
Record last verified: 2016-03