A Pilot-study to determine the (cost) effectiveness of the adhesion barrier 4DryField® PH in prevention of dysmenorrhea, abdominaal pain and niche-related problems after caesarean sections

Recruiting

• Conditions: Adhesions; dysmenorrhea; 10046828

• Registration Number: NL-OMON49995
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 114

Inclusion Criteria

- Patients who underwent their first CS (primary or secondary)
- Sufficient command of the Dutch or English language
- >= 18 years old

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Dysmenorrhea 9 months after the CS</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome: menstrual pattern (score card) and dysmenorhoe (VAS),<br /><br>Quality of life (SF36 & EQ-5D-5L), societal<br /><br>reintegration (PROMIS), sexual function (FSFI), Niche (characteristics),<br /><br>complications, surgery time and costs, % of ongoing<br /><br>pregnancies, life birth rate and time to conceive in women willing to conceive.</p><br>