Relation of Implantation Site to Placental Site in Presence or Absence of Cesarean Section Scar

Relation of Implantation Site to Placental Site in Presence or Absence of Cesarean Section Scar With Doppler Assessment of Retro Chorionic Blood Flow

After gaining verbal consent , Patients included in this study will be subjected to:

1. history taking :

   • peronal history .
   • obstetric history.
   • past history
2. general examination including vital signs
3. abominal and pelvic examination

4. the patient will be examined son graphically at 3 visits

   1. The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of---the site of the intrauterine gestational sac in relation to the endometrial cavity . For the purposes of this study and to obtain consistent findings, it was decided to have only five subgroups of gestational site implantation in relation to the endometrial cavity (Fig. 2):

      1. anterior,
      2. posterior,
      3. Fundal,
      4. low-lying anterior,\

      5. low lying posterior We adopted the definition of implantation site from previous publication (Abdallah et al., 2012). The implantation site is visualized in the sagittal plane as a hyperechoic ring that occupies one side of the implanted gestational sac and protrudes into the endometrial lumen It represents the maternal decidual reaction and the beginning of maternal-fetal circulation. This area is also believed to be responsible for future placental formation and development (Brosens and Gellersen, 2010) Distance between the implantation site and the internal cervical ostium (os). This was taken from the lower end of the hyperechoic trophoblast ring of the gestational sac to the internal cervical os in the sagittal plane.

         • doppler assessment of the retro chorionic blood flow in the area behind the maximum chorionic tissue to detect sensitivity index (RI),in cases of low gestational sac Doppler assessment of peri trophoplastic blood flow will be assessed.
   2. then the patient will be enrolled during routine ANC till delivery and data collected at32-34 weeks gestation regarding placental site will be correlated with 1st data and data at delivery

Study Overview

• Status: Unknown
• Conditions: Placenta Previa
• Intervention / Treatment: Radiation: trans vaginal ultrasound

Detailed Description

After gaining verbal consent , Patients included in this study will be subjected to:

1. history taking :

   • peronal history .
   • obstetric history.
   • past history
2. general examination including vital signs
3. abominal and pelvic examination

4. the patient will be examined son graphically at 3 visits

   1. The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of---the site of the intrauterine gestational sac in relation to the endometrial cavity . For the purposes of this study and to obtain consistent findings, it was decided to have only five subgroups of gestational site implantation in relation to the endometrial cavity (Fig. 2):

      1. anterior,
      2. posterior,
      3. Fundal,
      4. low-lying anterior,\
      5. low lying posterior

      We adopted the definition of implantation site from previous publication (Abdallah et al., 2012). The implantation site is visualized in the sagittal plane as a hyperechoic ring that occupies one side of the implanted gestational sac and protrudes into the endometrial lumen It represents the maternal decidual reaction and the beginning of maternal-fetal circulation. This area is also believed to be responsible for future placental formation and development (Brosens and Gellersen, 2010) Distance between the implantation site and the internal cervical ostium (os). This was taken from the lower end of the hyperechoic trophoblast ring of the gestational sac to the internal cervical os in the sagittal plane.

      -----doppler assessment of the retro chorionic blood flow in the area behind the maximum chorionic tissue to detect sensitivity index (RI),in cases of low gestational sac Doppler assessment of peri trophoplastic blood flow will be assessed.

   2. then the patient will be enrolled during routine ANC till delivery and data collected at32-34 weeks gestation regarding placental site will be correlated with 1st data and data at delivery

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Kasr Alainy Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

pregnant women with or without previous cesarean section scar are assessed at 10 weeks of gestational age then at 36 weeks to detect the relation between implantation site and placental site

Description

Inclusion Criteria:

• singleton intrauterine pregnancy.
• gestational age less than 10 weeks
• history of previous cesarean section(one or more)

Exclusion Criteria:

• negative fetal pole pulsation.
• any condition distorting uterine cavity i.e uterine myoma,uterine cavity anomalies
• multifetal pregnancy.
• any condition necessitate termination of early pregnancy i.e maternal medical disorder ,molar pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
women with previous cesarean scar; the patient will be examined son graphically at 3 visits; The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of---the site of the intrauterine gestational sac in relation to the endometrial cavity .-----doppler assessment of the retro chorionic blood flow in the area behind the maximum chorionic tissue to detect sensitivity index (RI),in cases of low gestational sac Doppler assessment of peri trophoplastic blood flow will be assessed.; then the patient will be enrolled during routine ANC till delivery and data collected at32-34 weeks gestation regarding placental site will be correlated with 1st data and data at delivery .	Radiation: trans vaginal ultrasound; trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of ---the site of the intrauterine gestational sac in relation to the endometrial cavity
women without previous cesarean scar; the patient will be examined son graphically at 3 visits; The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of---the site of the intrauterine gestational sac in relation to the endometrial cavity .-----doppler assessment of the retro chorionic blood flow in the area behind the maximum chorionic tissue to detect sensitivity index (RI),in cases of low gestational sac Doppler assessment of peri trophoplastic blood flow will be assessed.; then the patient will be enrolled during routine ANC till delivery and data collected at32-34 weeks gestation regarding placental site will be correlated with 1st data and data at delivery .	Radiation: trans vaginal ultrasound; trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of ---the site of the intrauterine gestational sac in relation to the endometrial cavity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placenta previa	measuring the distance between lower placental edge and internal os of the cervix by ultrasound	at 36 weeks of gestational age

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 15, 2017
• Primary Completion (ANTICIPATED): August 31, 2018
• Study Completion (ANTICIPATED): September 30, 2018

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (ACTUAL): July 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Previa
• Other Study ID Numbers: 6

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No