Back to resultsConservative Surgery for Placenta Accreta
Primary Purpose
Placenta Accreta
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
conservative surgery for uterus in placenta accreta
Sponsored by
About this trial
This is an interventional treatment trial for Placenta Accreta
Eligibility Criteria
Inclusion Criteria:
- Any age.
- Any parity.
- Previous one or more cesarean delivery.
- Placenta previa accreta diagnosis confirmed by gray scale & color flow Doppler ultrasound in 3rd trimester. All participants had undergone abdominal ultrasound showing placenta previa anterior completely covering the internal os, with criteria suggestive of invasion by U/S
Exclusion Criteria:
- women with medical disorder
- women with bleeding tendency
Sites / Locations
- Ain SHams Maternity Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Any age and parity with placenta accreta spectrum
Arm Description
After removal of the placenta, grasping the cervix from the both lips and one from each side of the cervical canal at the level of the internal os, each uterine angle and grasped the remaining lower uterine segment and Nelaton catheter was inserted inside the cervical canal to avoid closing the cervix with sutures of the uterine incision.Closing the uterine incision;taking suture at the lateral angle of the cervix and suturing it to the lower edge of the uterine angle, then another continuous suture was attached to the upper edge of the uterine incision angle[outside in-in out then out in-in out] and the same technique was repeated on the other side (cervico-isthmic sutures). controlling bleeding from the inner surface of the remaining lower uterine segment was done by 2-3 interrupted sutures between the lower uterine segment and the anterior cervical lip. closing of the uterine incision in continuous non-locking manner
Outcomes
Primary Outcome Measures
incidence rate of conserving woman's uterus
success rate of conservative surgery for placenta accreta
Secondary Outcome Measures
number of units of packed red blood cells , Fresh Frozen Plasma transfused ,postoperative haemoglobin
to assess blood loss
incidence rate of cesarean hysterectomy needed
failure of conservation , increase in blood loss
incidence of puerperal sepsis
temperature chart every 6 hours in 1st 48 hours postpartum then follow up visits 2 weeks and 6 weeks postpartum
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04981483
Brief Title
Conservative Surgery for Placenta Accreta
Official Title
Conservative Stepwise Surgical Approach for Management of Placenta Previa Accreta: a Prospective Case Series Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A stepwise surgical approach for conservative management of placenta previa accreta.
Detailed Description
a stepwise surgical approach for conservative management of placenta previa accreta to preserve women's uterus and to evaluate the efficacy and safety of this approach in controlling postpartum hemorrhage including intrapartum hemorrhage associated with conservative management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Accreta
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Any age and parity with placenta accreta spectrum
Arm Type
Experimental
Arm Description
After removal of the placenta, grasping the cervix from the both lips and one from each side of the cervical canal at the level of the internal os, each uterine angle and grasped the remaining lower uterine segment and Nelaton catheter was inserted inside the cervical canal to avoid closing the cervix with sutures of the uterine incision.Closing the uterine incision;taking suture at the lateral angle of the cervix and suturing it to the lower edge of the uterine angle, then another continuous suture was attached to the upper edge of the uterine incision angle[outside in-in out then out in-in out] and the same technique was repeated on the other side (cervico-isthmic sutures). controlling bleeding from the inner surface of the remaining lower uterine segment was done by 2-3 interrupted sutures between the lower uterine segment and the anterior cervical lip. closing of the uterine incision in continuous non-locking manner
Intervention Type
Procedure
Intervention Name(s)
conservative surgery for uterus in placenta accreta
Intervention Description
After removal of the placenta, grasping the cervix from the both lips and one from each side of the cervical canal at the level of the internal os, each uterine angle and grasped the remaining lower uterine segment and Nelaton catheter was inserted inside the cervical canal to avoid closing the cervix with sutures of the uterine incision.Closing the uterine incision;taking suture at the lateral angle of the cervix and suturing it to the lower edge of the uterine angle, then another continuous suture was attached to the upper edge of the uterine incision angle[outside in-in out then out in-in out] and the same technique was repeated on the other side (cervico-isthmic sutures). controlling bleeding from the inner surface of the remaining lower uterine segment was done by 2-3 interrupted sutures between the lower uterine segment and the anterior cervical lip. closing of the uterine incision in continuous non-locking manner
Primary Outcome Measure Information:
Title
incidence rate of conserving woman's uterus
Description
success rate of conservative surgery for placenta accreta
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
number of units of packed red blood cells , Fresh Frozen Plasma transfused ,postoperative haemoglobin
Description
to assess blood loss
Time Frame
till 48 hours postpartum
Title
incidence rate of cesarean hysterectomy needed
Description
failure of conservation , increase in blood loss
Time Frame
intraoperative and 48 hours postpartum
Title
incidence of puerperal sepsis
Description
temperature chart every 6 hours in 1st 48 hours postpartum then follow up visits 2 weeks and 6 weeks postpartum
Time Frame
till 6 weeks postpartum
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any age.
Any parity.
Previous one or more cesarean delivery.
Placenta previa accreta diagnosis confirmed by gray scale & color flow Doppler ultrasound in 3rd trimester. All participants had undergone abdominal ultrasound showing placenta previa anterior completely covering the internal os, with criteria suggestive of invasion by U/S
Exclusion Criteria:
women with medical disorder
women with bleeding tendency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mahmoud ghaleb, lecturer
Organizational Affiliation
ainshams university faculty of medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ain SHams Maternity Hospital
City
Cairo
State/Province
Abbaseya
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Conservative Surgery for Placenta Accreta
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