ClinicalTrials.gg
RecruitingNCT06493968Updated Jul 10, 2024

Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With PASD Undergoing Cesarean Hysterectomy

An interventional study of oxytocin and placebo in Placenta Accreta Spectrum, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

Objectives: To evaluate the effect of oxytocin in reducing intraoperative blood loss in patients with PAS disorders planned for cesarean hysterectomy.

02

Conditions studied

  • Placenta Accreta Spectrum

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03

In context

Placenta Accreta

150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.

This study's planned enrollment of 70 is close to the median of 70 across 67 interventional studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnancy of singleton living fetus
  • Previous one or more cesarean sections
  • Gestational age: > 32 weeks
  • The following ultrasound markers such as "loss of clear retroplacental translucency", "myometrial thinning", "abnormal lacunae", "irregular bladder wall", "utero-vesicalhypervascularity".
  • Preoperative more than 10 gm/dl
  • Cases with PAS that will undergoing CS Hysterectomy

Exclusion criteria

Exclusion Criteria:

  • Maternal medical disorders e.g.: coagulation defects, cardiac diseases etc.....
  • Any known or reported to the used medication.
  • All cases with spontaneous placental separation at laparotomy.
  • All patients undergoing conservative management of PAS.
  • All cases which necessitate emergency termination.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Group (A)

    Patients will be given uterotonics

    Drug: oxytocin

  • Placebo comparator
    Group (B)

    Patients will not be given uterotonics

    Other: placebo

Interventions

  • Uterotonics will be given in the form of an IV bolus of 10 units of oxytocin immediately with the uterine incision

  • Otherplacebo

    IV bolus of normal saline immediately with the uterine incision

06

What researchers measure

Primary outcomes

  1. Intraoperative blood loss

    amount of intraoperative blood loss in patients with PAS disorders undergoing cesarean hysterectomy

    Time frame: during operation

Secondary outcomes

  1. operative time

    Time frame: during operation

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06493968
Lead sponsor
Cairo University
Responsible party
Abdalla Mousa (Lecturer of obgyn Cairo university, Cairo University) — Principal investigator
First posted
Jul 10, 2024
Start date
Jul 1, 2024
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 10, 2024

Study contacts

Abdalla Mousa
Contact
Dr_abdallamousa@yahoo.com
+201277664430

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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