Paracervical Block During II-trimester Abortion

Second Trimester Medical Abortion Clinical Trial

Official title:

Paracervical Block (PCB) During II-trimester Abortion- A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617564
• Other study ID #: W2010IM
• Status: Completed
• Phase: N/A
• First received: May 31, 2012
• Last updated: May 15, 2015
• Start date: May 2012
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

Paracervical blockage can reduce severe pain during second trimester induced medical abortion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women who request second trimester medical abortion (13-22 weeks gestation according to ultrasound)

• 18 years of age or older

• able to understand and communicate in Swedish

• able to understand the study related information and willing to give her

• informed consent to participation in the study

Exclusion Criteria:

• Known allergy to bupivakain or related substances

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Second Trimester Medical Abortion

Intervention

Drug:
• bipuvacain
PCB with 20ml bupivakain or sodium cloride 9mg/ml will be administered one hour following misorpostol administration (first dose).

Other:
• NaCl
PCB with 20ml sodium chloride (9mg/ml) inactive (sham) comparator

Locations

Country	Name	City	State
Sweden	Dept of Obstetrics and Gynecology, Karolinska University Hospital	Stockholm
Sweden	Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Kristina Gemzell Danielsson

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Pain indicated on VAS at specific time intervals during the induction to expulsion	at 24 hours	No
Secondary	Efficacy	Number of complete abortions within 24h without the need for surgery	after 24h from induction	No
Secondary	Time to abortion	Time from induction (first dose of misoprostol) to expulsion	at 24hours	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	AEs reported during the time period from mifepristone (Day 1)until follow up	at 6 to 8 weeks	Yes