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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

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 - 4DryField Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49995
Enrollment
114
Registered
2020-11-18
Start date
2020-12-05
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Adhesions dysmenorrhea

Interventions

Aplication of adhesion prevention barriers (4DryField® PH ) in intervention group during a caesarean section.

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Dysmenorrhea 9 months after the CS

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)