A Pilot-study to determine the (cost)effectiveness of the adhesion barrier 4DryField® PH in prevention of dysmenorrhea, pain and niche-related problems after Caesarean sections
- Conditions
- Caesarean sectio, scar defect, niche, abnormal uterine bleeding, dysmenorrheaSectio caesarean, litteken defect, niche, abnormaal uterien bloedverlies, dysmenorroe
- Registration Number
- NL-OMON23062
- Lead Sponsor
- Amsterdam UMC, VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 110
Patients undergoing their first CS (planned or unplanned)
-Age = 18 years
-Patients with an indication for an emergency CS (suspicion of fetal distress), or patients in heavy pain without accurate therapy, and who were not informed about this study during pregnancy
-Previous uterine major surgery (e.g. laparoscopic or fibroid resection by laparotomy, septum resection)
-Patients with known causes of menstrual disorders (known cervical dysplasia, communicating hydrosalpinx, uterine anomaly or endocrine disorders disturbing ovulation) or use of medication that can influence the frequency of blood loss (e.g. Ascal).
-Placenta percreta during the current pregnancy
-Patients with chronic abdominal pain
-Patients who do not speak Dutch or English
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -dysmenorrhea 9 months* after the CS
- Secondary Outcome Measures
Name Time Method Secondary outcomes at 3 months:<br>-dysmenorrhea<br>-niche development<br>-adhesion formation examined by ultrasound<br>-short term and intraoperative complications due to the CS<br>Secondary outcomes at 9 months:<br>-abdominal pain<br>-related Quality of Life <br>-sexuality<br>-postmenstrual spotting<br>-medical consultation and medical interventions because of postmenstrual spotting, dysmenorrhea and pain<br>-long-term complications due to the CS<br>Secondary outcomes at 3 years <br>-fertility (% ongoing pregnancies, number of life birth rate, time to conceive) in women willing to conceive<br>-medical consultation and medical interventions