BridgeMD
New treatment option for Placenta Accreta Spectrum
Official title High vs. Low Segmental Hysterotomy: Impact on Uterine Wall Defects Post-Cesarean
ClinicalTrials.gov ID: NCT06620432
What this study is testing
- What it's testing
- The purpose of this clinical trial is to compare the incidence of defects in the uterine wall at the site of the scar (niche) and surgical complications when using high-segment versus low-segment hysterotomy, with both cross-suturing and non-cross-suturing techniques, in pregnant patients undergoing their first cesarean section. Researchers will compare four arms: Low Segment Hysterotomy + Crossed hysterorrhaphy High Segment Hysterotomy + Crossed hysterorrhaphy Low Segment Hysterotomy + Non-Crossed hysterorrhaphy High Segment Hysterotomy + Non-Crossed hysterorrhaphy Participants will: Cesarean delivery Attend a follow up appointment between 6 to 16 weeks post surgery where will be perform a transvaginal sonography.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- Pregnant women aged ≥ 18 years.
- Confirmed pregnancy through clinical history or ultrasound between 36 and 42 weeks of gestation.
- Indication by the attending gynecologist for a first cesarean section, either emergent or elective.
You likely can't join if
- History of myometrial intervention, such as myomectomy.
- History of genetic or acquired conditions that alter the anatomy of the uterus.
- History of coagulation disorders.
- History of connective tissue disorders, such as Lupus and Scleroderma, which may affect healing.
- Hemodynamically unstable patients due to a clinical condition prior to performing the cesarean section.
- Failure to sign the informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Cali, Valle del Cauca Department, Colombia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cali, Valle del Cauca Department, Colombia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.