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Completed

NCT Number: NCT02878187

Uterine Cavity and Blood Flow After Conservative Management of Placenta Previa/Accreta

Bleeding is the most significant cause of maternal death worldwide with more than half of those occurring within the first day of delivery. About 10.5% (some estimate as high at 12-17%) of live births world-wide, or about 14 million births, are complicated by postpartum hemorrhage; a woman dies every 4 minutes from postpartum hemorrhage. Uterine atony and placenta accreta are the two leading causes of postpartum hysterectomies with up to 64% of Cesarean hysterectomies done for abnormally adherent placentation

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Key information

Sex eligibility

Female

Study type

Observational

Primary location

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

About this study

No previous studies performed for evaluation of the effect of those procedures on the uterine cavity or uterine blood flow. Most of the studies in the literature evaluated the menstrual and fertility outcome after conservative measures for intraoperative hemorrhage due to placenta previa/accreta were retrospective and depend on the resumption of menses and pregnancy rate

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women Age 18-40 years
  • Gestational age of pregnancy 28-40 weeks
  • Diagnosed antenatally as placenta previa/accreta
  • Patients who will be managed by conservative surgical techniques for intraoperative hemorrhage
  • Women who will accept to participate in the study and are reliable for follow-up

Exclusion criteria

  • 1- Patients who will be managed by hysterectomy 2- Patients who will be managed by conservative leaving the placenta in-situ 3- Diabetic or hypertensive women 4- Women who will refuse to participate in the study

Treatment and study plan

Doppler

Device

Color Doppler ultrasound will be used to demonstrate the main ascending branches of left and right uterine arteries as they cross over the hypogastric vessels just before they enter the uterus at the uterine-cervical junction. The high pass filter was set at 125 Hz and the uterine artery will be obtained immediately after the crossing of the hypogastric artery. The sample volume will be placed on the artery with an angle of about 0°. After detection of blood flow and visu¬alization of the waveform of the uterine artery, five blood flow indices will be automatically cal¬culated:

The pulsatility index The resistance index The peak systolic velocity ; The end-diastolic velocity The time-averaged maximum

Primary outcomes

  1. The mean difference in the uterine arteries diameters in both groups

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Evaluation of the Uterine Cavity and Blood Flow After Conservative Management of Placenta Previa/Accreta

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 25, 2016
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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