Paracervical Block During II-trimester Abortion

N/ACompletedNCT01617564

Kristina Gemzell Danielsson112 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

112

Conditions

Second Trimester Medical Abortion

Interventions

bipuvacainDRUG

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

NaClOTHER

PCB with 20ml sodium chloride (9mg/ml) inactive (sham) comparator

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (2)

Dept of Obstetrics and Gynecology, Karolinska University Hospital

Stockholm, Sweden

Södersjukhuset

Stockholm, Sweden

Outcomes

Primary Outcomes

Pain score

Pain indicated on VAS at specific time intervals during the induction to expulsion

Time frame: at 24 hours

Secondary Outcomes

Efficacy

Number of complete abortions within 24h without the need for surgery

Time frame: after 24h from induction

Time to abortion

Time from induction (first dose of misoprostol) to expulsion

Time frame: at 24hours

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

Time frame: at 6 to 8 weeks

Data from ClinicalTrials.gov

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