NCT07520201

Brief Summary

Comparison between modified one-step surgery vs. Segment Resection vs. placental bed suturing for management of placenta accreta spectrum

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress4%
Jun 2026Jul 2027

First Submitted

Initial submission to the registry

April 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 3, 2026

Last Update Submit

April 3, 2026

Conditions

Keywords

Segment ResectionModified one-stepPlacental bed plicationConservative uterine surgery

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Blood loss

    Increased blood loss means bad outcome

    24 hours

Study Arms (3)

Modified one-step surgery

EXPERIMENTAL
Procedure: Modified one-step surgery

Segment Resection

EXPERIMENTAL
Procedure: Segment Resection

Placental bed suturing

EXPERIMENTAL
Procedure: Placental bed suturing

Interventions

transverse uterine incision is made at the upper border of the placenta without cutting through the placenta, then fetal delivery. A tourniquet is first put into the para-cervical area (using a Foley 12-F catheter) to stop active bleeding, and bilateral uterine artery ligation (using Chromic 1/0) is performed, followed by manual placental removal . Myometrial resection is performed if the remaining lower uterine segment of the healthy myometrium measures more than 2 cm. Suture of both edges of the uterine incision and hemostatic sutures of the placental bed surface (using chromic suture 1/0) are performed. Finally, the tourniquet is released and a transverse B-Lynch compression suture is made

Modified one-step surgery

transverse uterine incision was applied just above the upper border of involved uterine wall . And the fetus was extracted from this incision and the umbilical cord was clamped. In order to decrease hemorrhage, anterior branches of hypogastric arteries were ligated bilaterally. urinary bladder dissection from anterior uterine wall is done. Then the involved segment is resected by leaving placental free tissue medially to the uterine arteries, below transverse uterine incision and above the cervix. Resection was made by scissors or cautery and bleeding from the borders was controlled by ring forceps.

Segment Resection

After the separation of the placenta, all bleeding areas are clamped with several curved ovarian forceps. After the mechanical hemostasis of the lower uterine segment has been achieved, the remaining small amounts of placental fragments are removed by instrument. The clamps are removed sequentially, and the vesicouterine interface and all spaces are sutured with superficial stitches under the guidance of the surgeon's fingers. These superficial continuous sutures are not very deep. Cho sutures are used to achieve comlete hemostasis.

Placental bed suturing

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant women with placenta accreta spectrum

You may not qualify if:

  • Patients refuse to share in the study
  • Pregnant \< 28 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health Hospital

Asyut, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer obstetric and gynecology, Specialist Urogynecology

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 9, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations