NCT05104177

Brief Summary

To evaluate the effectiveness of conservative techniques for placenta accreta spectrum to reduce maternal mortality and morbidity

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Status
unknown

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

October 9, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

October 9, 2021

Last Update Submit

November 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of patients who undergo hysterectomy after failure of conservative techniques

    Counting patients who undergo hystrectomy after conservative techniques to evalute it's effectivness

    baseline

Secondary Outcomes (1)

  • recurrence of PAS

    baseine

Interventions

Meticulous complete dissection of the urinary bladder from the lower uterine segment. * Transverse uterine incision above the visible vascular bulge if visible in cases with anterior PAS, otherwise a transverse lower uterine segment incision is performed in the same site of previous CS scar. * Delivery of the baby, clamping of the cord and administration IV 10 IU oxytocin. * Bilateral uterine artery ligation at one or two levels below the lowermost part of the placenta. * Removal of the separable part of the placenta from above downwards, until the adherent part is encountered. * A decision is taken to either resect a wedge of the myometrium above the adherent placenta (in case the adherent area is small and anterior), or removing all the adherent placenta then inserting a rubber or plastic catheter inside the cervical canal then identifying and closing the placental pouch. Care is given to rapidly perform this step to decrease the blood loss after removing the placenta

Eligibility Criteria

Age19 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales in reproductive age
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

females in reproductive age

You may qualify if:

  • \- Gestational age starting from 28 weeks onwards.
  • \- Women with at least 1 previous hysterotomy (e.g. Caesarean deliveries, myomectomy)
  • \- Elective or emergent Caesarean deliveries

You may not qualify if:

  • A pre-existing decision of performing intrapartum hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24.

    PMID: 28599899BACKGROUND

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Central Study Contacts

mohammed heshmat

CONTACT

Alaa El-Din Ismail

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 9, 2021

First Posted

November 2, 2021

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

November 9, 2021

Record last verified: 2021-11