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

Evaluation of the 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

Study Overview

• Status: Completed
• Conditions: Improving Quality of Life
• Intervention / Treatment: Device: Doppler

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Assiut, Cairo, Egypt, 002
      • Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All women delivered by elective/emergency cesarean section due to placenta previa/accreta during the study period will be included in the study.

Description

Inclusion Criteria:

1. Women Age 18-40 years
2. Gestational age of pregnancy 28-40 weeks
3. Diagnosed antenatally as placenta previa/accreta
4. Patients who will be managed by conservative surgical techniques for intraoperative hemorrhage
5. 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
placenta previa; all women managed by conservative surgical techniques during cesarean section after intraoperative hemorrhage due to placenta previa/accreta	Device: Doppler; 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
healthy controls; women delivered by Cesarean for any other indication with no intraoperative hemorrhage or any additional surgical techniques performed during Cesarean	Device: Doppler; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The mean difference in the uterine arteries diameters in both groups	3 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ahmed Abbas, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Previa
• Other Study ID Numbers: PP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES