NCT04981483

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

1.3 years

First QC Date

July 6, 2021

Last Update Submit

December 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • incidence rate of conserving woman's uterus

    success rate of conservative surgery for placenta accreta

    intraoperative

Secondary Outcomes (3)

  • number of units of packed red blood cells , Fresh Frozen Plasma transfused ,postoperative haemoglobin

    till 48 hours postpartum

  • incidence rate of cesarean hysterectomy needed

    intraoperative and 48 hours postpartum

  • incidence of puerperal sepsis

    till 6 weeks postpartum

Study Arms (1)

Any age and parity with placenta accreta spectrum

EXPERIMENTAL

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

Interventions

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

Any age and parity with placenta accreta spectrum

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • women with medical disorder
  • women with bleeding tendency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain SHams Maternity Hospital

Cairo, Abbaseya, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • mahmoud ghaleb, lecturer

    ainshams university faculty of medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant professor of obstetrics and gynaecology

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 29, 2021

Study Start

January 1, 2018

Primary Completion

April 15, 2019

Study Completion

June 30, 2019

Last Updated

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations