NCT07519993

Brief Summary

This study evaluates whether adding Hayman sutures in the conservative Management of Placenta Accreta Spectrum Using Kasr Al-Ainy Technique reduces intraoperative blood loss and improves outcomes

Trial Health

65
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Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Apr 2026

Shorter than P25 for not_applicable

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 Progress27%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

April 2, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

April 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 2, 2026

Last Update Submit

April 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intra-operative estimated blood loss

    During operation

Study Arms (2)

Kasr Al-Ainy Technique Alone

ACTIVE COMPARATOR
Procedure: Kasr Al-Ainy Technique Alone

Kasr Al-Ainy Technique + Hayman Sutures

EXPERIMENTAL
Procedure: Kasr Al-Ainy Technique + Hayman Sutures

Interventions

1. Vascular Ligation: Bilateral uterine artery tying at high and low levels. 2. Compression Sutures: Anterior and posterior cervicovaginal stitches for hemostasis. 3. Segmental Resection: Excision of invaded myometrium and placental tissue. 4. Dual-Layer Repair: Myometrial approximation followed by reinforcing imbricating sutures. 5. Final Hemostasis: Confirmation of bleeding control prior to abdominal closure.

Kasr Al-Ainy Technique Alone

1. Vascular Ligation: Bilateral uterine artery tying at high and low levels. 2. Compression Sutures: Anterior and posterior cervicovaginal stitches for hemostasis. 3. Segmental Resection: Excision of invaded myometrium and placental tissue. 4. Dual-Layer Repair: Myometrial approximation followed by reinforcing imbricating sutures. 5. Final Hemostasis: Confirmation of bleeding control prior to abdominal closure. 6. Application of Hayman vertical compression sutures

Kasr Al-Ainy Technique + Hayman Sutures

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40 years
  • Antenatal PAS diagnosis confirmed by TAS/TVS/Doppler
  • Eligible for conservative Kasr Al-Ainy surgery
  • Singleton pregnancy
  • Written informed consent

You may not qualify if:

  • Multiple pregnancy
  • Uterine fibroids
  • Previous cesarean myomectomy
  • Cervical accreta
  • Extensive parametrial or bladder invasion requiring hysterectomy
  • Known coagulopathy or uncorrected bleeding disorder.
  • Severe medical comorbidities rendering the patient unfit for major surgery under general anesthesia (e.g., severe cardiac or pulmonary disease)
  • Medical disorders as HTN and DM
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • Emad Salah, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR
  • Mona Sedik, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 9, 2026

Study Start

April 5, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04