NCT03241849

Brief Summary

Placenta accreta is an obstetrical complication where the placenta becomes firmly adherent to the uterine wall. Placenta accreta can lead to considerable maternal morbidity and mortality due to hemorrhage, infection, or other surgical complications such as those resulting from hysterectomy. Retained placenta accreta is usually a rare condition, but its prevalence is increasing due to the rise in the rate of deliveries by Cesarean section. Placenta accreta is a potentially life-threatening obstetric condition that requires a multidisciplinary approach to management. The incidence of placenta accreta has increased and seems to parallel the increasing cesarean delivery rate. Women at greatest risk of placenta accreta are those who have myometrial damage caused by a previous cesarean delivery with either an anterior or posterior placenta previa overlying the uterine scar. Diagnosis of placenta accreta before delivery allows multidisciplinary planning in an attempt to minimize potential maternal or neonatal morbidity and mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

2.4 years

First QC Date

August 1, 2017

Last Update Submit

June 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Amount of blood loss (mL)

    24 hours

Study Arms (1)

Modified surgical technique for placenta accreta

OTHER
Procedure: Modified surgical technique for placenta accreta

Interventions

suturing of the myometrium splitted by the placenta in cases presented by placenta accreta

Modified surgical technique for placenta accreta

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Estimated gestational age between 34 -40 weeks .
  • Presence of total or focal parts of placenta accreta "morbidly adherent placenta" .
  • Cases with mild vaginal bleeding or not having any vaginal bleeding

You may not qualify if:

  • Severe attack of bleeding require an immediate intervention.
  • Associated with placental abruption
  • Patients with known bleeding disorders or on anticoagulant therapy.
  • Preoperative decision to do peripartum hysterectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 8, 2017

Study Start

August 1, 2017

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

June 23, 2020

Record last verified: 2020-06

Locations