Impact of a Bladder Flap on Cesarean Scar Niche Development
ConditionCesarean Scar Defect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMontefiore Medical Center
About this trial
The goal of this trial is to examine if the completion or omission of a bladder flap impacts the location and formation of cesarean scar niche in women undergoing primary cesarean section. The main question it aims to answer is if omission of a bladder flap changes the prevalence of cesarean scar niche on a 6-8 week postpartum ultrasound. Researchers will compare participants that have a bladder flap made to those that have a bladder flap omitted at time of their primary cesarean delivery. Participants will have routine postpartum care and be asked to return for a 6-8 week postpartum transvaginal ultrasound.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Primary low transverse cesarean section performed at Montefiore Weiler or Wakefield Hospitals
Able to provide informed consent in English or Spanish
Plan for postpartum care at Montefiore Medical Center
Disqualifiers
History of a prior uterine surgery
Known congenital uterine anomalies
Inability to safely access lower uterine segment at time of delivery
Hysterotomy is extended past/outside the lower uterine segment at time of surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Bladder flap formation
Procedure/SurgeryParticipants in this arm will have a bladder flap completed at the time of their cesarean delivery.
Treatment groups
338 Participants
are divided into 2 treatment groupsGroup A: Bladder flap omissionNo intervention 0 interventions
Group B: Bladder flap formationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Presence of cesarean scar niche
A dichotomous measure of the presence or absence of a cesarean scar niche, as defined by a residual myometrial thickness of \<3mm at the scar level, detected on transvaginal ultrasound. The presence of a cesarean scar niche increases risk for gynecologic complaints and abnormal placentation in subsequent pregnancies.
Time frame
From enrollment to transvaginal ultrasound, completed approximately 6-8 weeks postpartumSecondary outcomes
1
Distance of cesarean scar niche from internal os
Sonographic distance of cesarean scar niche from internal cervical os, measured in millimeters, on postpartum transvaginal ultrasound. The investigator team hypothesizes that a scar further from the internal os has increased risk for abnormal placentation in future pregnancies.
Time frame
From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum2
Size of cesarean scar niche
Sonographic dimensions of length and width of cesarean scar niche, measured in mm, on transvaginal ultrasound. The investigator team hypothesizes that larger niches are associated with increased risk of abnormal placentation in future pregnancies and increased risk of future gynecologic complaints.
Time frame
From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum3
Measurement of residual myometrium
Sonographic measurement of residual myometrium in mm by transvaginal ultrasound. Thinner residual myometrium may imply a larger defect, increased risk for abnormal placentation or formation of a uterine window in future pregnancies.
Time frame
From enrollment to time of transvaginal ultrasound, completed approximately 6-8 weeks postpartum4
Size of cesarean scar defect in subsequent pregnancy
Sonographic measurement of dimensions (length and width) of cesarean scar defect in subsequent pregnancy, measured in mm, to assess if larger postpartum niches are associated with larger defects in subsequent pregnancies as they may carry increased risk of morbidity in the pregnancy.
Time frame
From time of enrollment to time of subsequent pregnancy, up to 5 years following baseline pregnancySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov