Conservative Surgery for Placenta Accreta

Long-term Follow-up of the Cases Who Underwent Conservative Surgery for Placenta Previa Accreta

A stepwise surgical approach for conservative management of placenta previa accreta.

Study Overview

• Status: Completed
• Conditions: Placenta Accreta
• Intervention / Treatment: Procedure: conservative surgery for uterus in placenta 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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbaseya
    • Cairo, Abbaseya, Egypt
      • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Any age and parity with placenta accreta spectrum; 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

Procedure: conservative surgery for uterus in placenta accreta; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence rate of conserving woman's uterus	success rate of conservative surgery for placenta accreta	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of units of packed red blood cells , Fresh Frozen Plasma transfused ,postoperative haemoglobin	to assess blood loss	till 48 hours postpartum
incidence rate of cesarean hysterectomy needed	failure of conservation , increase in blood loss	intraoperative and 48 hours postpartum
incidence of puerperal sepsis	temperature chart every 6 hours in 1st 48 hours postpartum then follow up visits 2 weeks and 6 weeks postpartum	till 6 weeks postpartum

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: mahmoud ghaleb, lecturer, Ainshams university faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Accreta
• Other Study ID Numbers: 11784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No