Second Trimester Medical Abortion
Conditions
Keywords
medical abortion, second trimester, para cervical blockage, pain management
Brief summary
Paracervical blockage can reduce severe pain during second trimester induced medical abortion.
Interventions
DRUGbipuvacain
PCB with 20ml bupivakain or sodium cloride 9mg/ml will be administered one hour following misorpostol administration (first dose).
OTHERNaCl
PCB with 20ml sodium chloride (9mg/ml) inactive (sham) comparator
Sponsors
Kristina Gemzell Danielsson
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | at 24 hours | Pain indicated on VAS at specific time intervals during the induction to expulsion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | after 24h from induction | Number of complete abortions within 24h without the need for surgery |
| Time to abortion | at 24hours | Time from induction (first dose of misoprostol) to expulsion |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | at 6 to 8 weeks | AEs reported during the time period from mifepristone (Day 1)until follow up |
Countries
Sweden
Outcome results
None listed