Adhesions, niche, isthmocele, cesarean scar disorder, chronic pelvic pain
Conditions
Interventions
Closure of peritoneum during cesarean section
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients undergoing their first CS (planned or unplanned) Age =18 years
Exclusion criteria
Exclusion criteria: Women with previous abdominal or uterine surgery History of menstrual disorders including severe dysmenorrhea (e.g. cervical dysplasia, communicating hydrosalpinx, uterine anomaly, endocrine disorders or disturbing ovulation) History of chronic pelvic pain Inadequate opportunities for counselling due to labour (emergency CS without prior study information, severe pain without adequate management, being in heavy labour) Placenta accreta spectrum during current pregnancy = three fetuses during the current pregnancy Participants who do not speak Dutch or English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life 12 months after cesarean section | — |
Secondary
| Measure | Time frame |
|---|---|
| TVUS outcomes at 3 and 12 months after CS: Presence of vesicouterine adhesions diagnosed with the sliding bladder sign by transvaginal ultrasound examination Presence of a uterine niche (>2mm) on transvaginal ultrasound, including the size of the niche and residual myometrium. Menstrual health outcomes: Dysmenorrhea, measured by NRS on a scale from 0-10. Post menstrual spotting defined as intermenstrual (bleeding after at least 1 day without bleeding) or postmenstrual spotting (little amounts of red or brown blood loss immediately following normal menstruation). Dysuria Usage of hormonal contraception Breastfeeding Surgical outcomes: Reason for CS Bladder flap created Operative time Peri-operative blood loss Postoperative pain measured by NRS on a scale from 0-10 and need for analgesics Postoperative complications such as wound infection, fever, bleeding, readmission Other: Chronic pelvic pain (intermittent or constant pain in the lower abdomen or pelvis for at least six months (35)), measured by NRS on a scale from 0-10. FSFI for sexual function and dyspareunia SF-36 Mental Component Score (MCS) EQ-5D-5L PROMIS Medical consultation and medical interventions because of postmenstrual spotting, dysmenorrhea and abdominal pain (included in questionnaire about menstrual cycle and related symptoms). | — |
Countries
Netherlands
Contacts
Public ContactR.A. Leeuw
Amsterdam UMC
Outcome results
None listed