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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23062

Enrollment

110

Registered

2019-10-09

Start date

2019-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarean sectio, scar defect, niche, abnormal uterine bleeding, dysmenorrhea Sectio caesarean, litteken defect, niche, abnormaal uterien bloedverlies, dysmenorroe

Interventions

Subjects will receive treatment with the investigational product 4DryField® PH after closure of the uterus. The powder is applied directly onto the uterine scar and then transformed into a gel through

Eligibility

Inclusion criteria

Inclusion criteria: - Patients undergoing their first CS (planned or unplanned) - Age = 18 years

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
-dysmenorrhea 9 months* after the CS	—

Secondary

Measure	Time frame
Secondary outcomes at 3 months: - dysmenorrhea - niche development - adhesion formation examined by ultrasound - short term and intraoperative complications due to the CS Secondary outcomes at 9 months: - abdominal pain - related Quality of Life - sexuality - postmenstrual spotting - medical consultation and medical interventions because of postmenstrual spotting, dysmenorrhea and pain - long-term complications due to the CS Secondary outcomes at 3 years - fertility (% ongoing pregnancies, number of life birth rate, time to conceive) in women willing to conceive - medical consultation and medical interventions	—

Measure

Time frame

Secondary outcomes at 3 months: - dysmenorrhea - niche development - adhesion formation examined by ultrasound - short term and intraoperative complications due to the CS Secondary outcomes at 9 months: - abdominal pain - related Quality of Life - sexuality - postmenstrual spotting - medical consultation and medical interventions because of postmenstrual spotting, dysmenorrhea and pain - long-term complications due to the CS Secondary outcomes at 3 years - fertility (% ongoing pregnancies, number of life birth rate, time to conceive) in women willing to conceive - medical consultation and medical interventions

—

Contacts

Public ContactMD. PhD. R.A. de Leeuw

VUmc

r.a.deleew@amsterdamumc.nl+31 (0)20 4440090

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)