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Compares treatment options for Cesarean Section; Dehiscence
Official title Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06308172
What this study is testing
- What it's testing
- The objective of this randomized monocentric study is to assess potential variations in the incidence and severity of isthmocele morbidity among women undergoing cesarean section with either single or double-layer closure of the hysterotomy. Our primary outcome aims to investigate whether there is a reduction in the median duration of intermenstrual spotting in patients belonging to the two respective closure groups
- Which group you join is decided by chance.
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
You may be able to join if
- nulliparous
- singleton
- age 18-45
- spontaneous pregnancy or autologous assisted fertilization
- gestational age 38-40 weeks
You likely can't join if
- coagulopathy
- autoimmune diseases
- gestational diabetes
- anticoagulant therapy
- immunosuppressive therapy
- endometriosis
See the full eligibility criteria
- nulliparous
- singleton
- age 18-45
- spontaneous pregnancy or autologous assisted fertilization
- gestational age 38-40 weeks
- elective C-section
- informed consent
- coagulopathy
- autoimmune diseases
- gestational diabetes
- anticoagulant therapy
- immunosuppressive therapy
- endometriosis
- uterine fibromatosis
- spontaneous labour
- connective tissue diseases
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Mi, Italy
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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Mi, Italy. 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.