Hemostatic Procedure After Biopsy of the Cervix

Is a Hemostatic Procedure Required After Biopsy of the Cervix Uteri in Women Undergoing Colposcopy for Cervical Dysplasia? A Multicenter Randomized Non-inferiority Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02486471

Enrollment

166

Registered

2015-07-01

Start date

2015-07-31

Completion date

2016-02-29

Last updated

2016-02-17

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

Conditions

Uterine Cervical Dysplasia

Keywords

cervical dysplasia, colposcopy, haemostatic procedure, biopsy of the cervix uteri

Brief summary

Cytological abnormalities of the Cervix uteri need to be clarified by colposcopy biopsy. To avoid bleeding after biopsy, monsel´s paste is a common used Agent. In a randomized clinical Trial the use of monsel´s paste after biopsy will be compared to no Intervention. The Primary outcome of the study is blood loss, secondary outcomes are pain, satisfaction of the patient and influence of Independent factors such as Age and Body mass index.

Interventions

PROCEDUREMonsel´s Paste

surgical method to stop bleeding by using the hemostatic Agent monsel´s paste until no more bleeding is visible

OTHERWait and see

finishing examination without hemostatic intervention, awaiting spontaneous coagulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* abnormal pap smear * first colposcopy ever

Exclusion criteria

* pregnancy * bleeding disorder * the use of blood thinner * language barrier * unwillingness to participate

Design outcomes

Primary

Measure	Time frame	Description
Blood loss after 15 minutes (5-step visual analogue scale)	15 minutes	blood loss 15 minutes after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)

Secondary

Measure	Time frame	Description
Blood loss after 6 hours (5-step visual analogue scale)	6 hours	blood loss 6 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)
Blood loss after 24 hours (5-step visual analogue scale)	24 hours	blood loss 24 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)
Blood loss after 3 hours (5-step visual analogue scale)	3 hours	blood loss 3 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)
Overall Sensation of pain after 24 hours (10-step visual analogue scale)	24 hours	patients will score their pain Level using a 10-step visual analogue scale (VAS) 24 hours after biopsy
Overall Satisfaction of the Patient after 24 hours (10-step visual analogue scale)	24 hours	patients will score their satisfaction Level using a 10-step visual analogue scale (VAS)
Sensation of pain after 15 minutes (10-step visual analogue scale)	15 minutes	patients will score their pain Level using a 10-step visual analogue scale (VAS) 15 minutes after biopsy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026