Impact of a Bladder Flap on Cesarean Scar Niche Development
ConditionCesarean Scar Defect (Isthmocele)
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- Bladder flap formation
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov