AzTrials
AzTrials

Placenta AccretaNCT04264169

Risk Factors for Occurrence of Placenta Accrete Spectrum Following Primary Cesarean Delivery

An observational study of Placenta Accreta, run by Mansoura University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will be conducted on a group of patients undergoing repeat elective caesarean delivery attending at Mansoura university hospital. This study will investigate patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one caesarean delivery in the period… Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Placenta Accreta
How many people
200 participants
Where
1 siteEgypt
Study dates
1 Jan 2020to 21 Jan 2021
How long will I take part?
1 Week
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: This study will be conducted on a group of patients undergoing repeat elective cesarean delivery attending at Mansoura university hospital. - This study will investigate patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one cesarean delivery

Who may be able to join

  • Patients with history of previous one caesarean delivery
  • Patients who refused trail of vaginal birth after caesarean section
  • Patients with permanent indication for caesarean section like contracted pelvis
  • Patient without any history of medical diseases

Who cannot join

  • Patients with history of more than one previous caesarean delivery
  • Patients with medical disorders complicating pregnancy kike preeclampsia and gestational diabetes mellitus
  • Patients with known uterine abnormalities eg (Bicornuate uterus, Adenomyosis, Submucous fibroids and Myotonic dystrophy)
  • Patients who are candidates for vaginal birth after caesarean section

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Medicine

    Al Mansurah, Dakahlia Governorate, 050

Other trials in Egypt

About this study

This study will be conducted on a group of patients undergoing repeat elective caesarean delivery attending at Mansoura university hospital.

  • This study will investigate patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one caesarean delivery in the period between (January 2020 till January 2021).
Read the detailed description

Participants in this study will be a group of patients with past history of previous one caesarean delivery and attending for elective termination of the current pregnancy.

Patients data will be collected and analysed as following:

  • Personal data: Age, residency, job, special habits, BMI
  • Past obstetric history:

Gravidity, parity, full term normal delivery, full term assisted vaginal deliveries, preterm, stillbirth, abortion, previous pregnancy complication and complication during puerperium • Previous delivery: Indication, duration, place of delivery, results of delivery, complication during labour, complication during puerperium

  • Past medical, surgical or gynaecological history
  • Pregnancy by assisted reproductive techniques
  • Current pregnancy complications
  • Trans abdominal and trans vaginal ultrasound examination Patients will be considered to have placenta praevia if the lower edge of the placenta is less than 2 cm form the internal os of the cervix

Placenta accreta will be considered as the following(7, 8) (Placental lacunae, Loss of hypoechoic space, Abnormalities of uterus-bladder interface, Color Doppler abnormalities)

2D grey-scale Loss of the "clear zone" Loss or irregularity of the hypoechoic plane in the myometrium underneath the placental bed (the "clear zone") Abnormal placental lacunae Presence of numerous lacunae including some that are large and irregular (Fin berg grade 3) often containing turbulent flow visible in grey-scale imaging Bladder wall interruption Loss or interruption of the bright bladder wall (the hyperechoic band or "line" between the uterine serosa and the bladder lumen) Myometrial thinning Thinning of the myometrium overlying the placenta to <1 mm or undetectable Placental bulge Deviation of the uterine serosa away from the expected plane, caused by an abnormal bulge of placental tissue into a neighbouring organ, typically the bladder. The uterine serosa appears intact but the outline shape is distorted Focal exophytic mass Placental tissue seen breaking through the uterine serosa and extending beyond it. Most often seen inside a filled urinary bladder Color Doppler imaging Uterovesical hypervascularity Striking amount of colour Doppler signal seen between the myometrium and the posterior wall of the bladder. This sign probably indicates numerous, closely packed, tortuous vessels in that region (demonstrating multi-directional flow and aliasing artifact) Subplacental hypervascularity Striking amount of color Doppler signal seen in the placental bed. This sign probably indicates numerous,closely packed, tortuous vessels in that region (demonstrating multidirectional flow and aliasing artifact)

Bridging vessels Vessels appearing to extend from the placenta across the myometrium and beyond the serosa into the bladder or other organs. Often running perpendicular to the myometrium

Placental lacunae feeder vessels Vessels with high velocity blood flow leading from the myometrium into the placental lacunae, causing turbulence upon entry

At laparotomy the following data will be reviewed(6):

Grade 1: Abnormally adherent placenta (placenta adherenta or accreta)

  • Macroscopically, the uterus shows no obvious distension over the placental bed (placental "bulge"), no placental tissue is seen invading through the surface of the uterus, and there is no or minimal neovascularity Grade 2: Abnormally invasive placenta (Increta)
  • Abnormal macroscopic findings over the placental bed: bluish/purple colouring, distension (placental "bulge")
  • Significant amounts of hypervascularity (dense tangled bed of vessels or multiple vessels running parallel craniocaudially in the uterine serosa)
  • No placental tissue seen to be invading through the uterine serosa.
  • Gentle cord traction results in the uterus being pulled inwards without separation of the placenta (so-called the dimple sign) Histologic criteria
  • Hysterectomy specimen or partial myometrial resection of the increta area shows placental villi within the muscular fibers and sometimes in the lumen of the deep uterine vasculature (radial or arcuate arteries) Grade 3: Abnormally invasive placenta (Percreta) Grade 3a: Limited to the uterine serosa Clinical criteria
  • At laparotomy
  • Abnormal macroscopic findings on uterine serosal surface (as above) and placental tissue seen to be invading through the surface of the uterus
  • No invasion into any other organ, including the posterior wall of the bladder (a clear surgical plane can be identified between the bladder and uterus)
  • Histologic criteria
  • Hysterectomy specimen showing villous tissue within or breaching the uterine serosa Grade 3b: With urinary bladder invasion Clinical criteria
  • At laparotomy
  • Placental villi are seen to be invading into the bladder but no other organs
  • Clear surgical plane cannot be identified between the bladder and uterus Histologic criteria
  • Hysterectomy specimen showing villous tissue breaching the uterine serosa and invading the bladder wall tissue or urothelium Grade 3c: With invasion of other pelvic tissue/organs Clinical criteria
  • At laparotomy
  • Placental villi are seen to be invading into the broad ligament, vaginal wall, pelvic sidewall or any other pelvic organ (with or without invasion of the bladder) Histologic criteria • Hysterectomy specimen showing villous tissue breaching the uterine serosa and invading pelvic tissues/organs (with or without invasion of the bladder) .For the purposes of this classification, "uterus" includes the uterine body and uterine cervix .
  • The data will be analysed after putting it in the following groups,
  • study group consisted of patients with placenta praevia diagnosed by TVUS, control group consisted of patients undergoing elective caesarean delivery without having placenta praevia by transvaginal ultrasound (TVUS) examination
Keywords
placenta accrete spectrum, ultrasound, Risk factors
Medical subject headings
Placenta Accreta

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04264169
Study groupRoleWhat they receive
• Study group100 patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one cesarean delivery and the current pregnancy will be complicated by placenta accreta spectrum
• Control group100 patients' attending to the antenatal care clinic for elective termination of pregnancy with history of previous one cesarean delivery and the current pregnancy will not be complicated by placenta accreta spectrum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. association between indication of primary Cesarean delivery and degree of severity of placenta accreta spectrum

    association between indication of primary Cesarean delivery and degree of severity of placenta accreta spectrum

    Measured: 1 day

Secondary outcomes (1)
  1. the association between parity, gravidity, place of the primary Cesarean delivery, assisted conception, and vaginal delivery before and after the primary Cesarean delivery,postpartum complications and degree of placenta accreta spectrum

    the association between parity, gravidity, place of the primary Cesarean delivery, assisted conception, and vaginal delivery before and after the primary Cesarean delivery ,postpartum complications and degree of placenta accreta spectrum

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start1 Jan 2020
  3. Primary completion21 Jan 2021
  4. Study completion21 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
Target duration
1 Week
IDs, dates and publications
ClinicalTrials.gov ID
NCT04264169
Sponsor's protocol ID
R.19.12.685
Status last verified
Jan 2021
First submitted
7 Feb 2020
Last updated
22 Jan 2021
Results posted
No
Individual data sharing
No

Publications

  • Jauniaux E, Chantraine F, Silver RM, Langhoff-Roos J; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Epidemiology. Int J Gynaecol Obstet. 2018 Mar;140(3):265-273. doi: 10.1002/ijgo.12407. No abstract available.

    PubMed 29405321

Questions about this trial

What is this clinical trial studying?

An observational study of Placenta Accreta, run by Mansoura University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

association between indication of primary Cesarean delivery and degree of severity of placenta accreta spectrum (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04264169, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in