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Paracervical blockage can reduce severe pain during second trimester induced medical abortion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacain | Active Comparator |
| |
| Sodium Chloride | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bipuvacain | Drug | PCB with 20ml bupivakain or sodium cloride 9mg/ml will be administered one hour following misorpostol administration (first dose). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Pain indicated on VAS at specific time intervals during the induction to expulsion | at 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Number of complete abortions within 24h without the need for surgery | after 24h from induction |
| Time to abortion | Time from induction (first dose of misoprostol) to expulsion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Gemzell Danielsson, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Obstetrics and Gynecology, Karolinska University Hospital | Stockholm | SE17176 | Sweden | |||
| Södersjukhuset |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26573530 | Derived | Andersson IM, Benson L, Christensson K, Gemzell-Danielsson K. Paracervical block as pain treatment during second-trimester medical termination of pregnancy: an RCT with bupivacaine versus sodium chloride. Hum Reprod. 2016 Jan;31(1):67-74. doi: 10.1093/humrep/dev286. Epub 2015 Nov 15. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| NaCl | Other | PCB with 20ml sodium chloride (9mg/ml) inactive (sham) comparator |
|
| 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 | at 6 to 8 weeks |
| Stockholm |
| Sweden |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |