Second Trimester Medical AbortionNCT01617564
Paracervical Block During II-trimester Abortion
A study testing bipuvacain and NaCl in people with Second Trimester Medical Abortion, run by Kristina Gemzell Danielsson at 2 sites in Sweden.
Trial summary
Paracervical blockage can reduce severe pain during second trimester induced medical abortion. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Second Trimester Medical Abortion
- What is being tested?
- bipuvacain and NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 2 sitesSweden
- Study dates
- May 2012to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Known allergy to bupivakain or related substances
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Dept of Obstetrics and Gynecology, Karolinska University Hospital
Stockholm, SE17176
Södersjukhuset
Stockholm
About this study
Official title: Paracervical Block (PCB) During II-trimester Abortion- A Randomized Controlled Trial
Paracervical blockage can reduce severe pain during second trimester induced medical abortion.
- Conditions
- Second Trimester Medical Abortion
- Being tested
- bipuvacain, NaCl
- Keywords
- medical abortion, second trimester, para cervical blockage, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bipuvacainDrug
Also called (Marcain® 2,5mg/ml)
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
| Study group | Role | What they receive |
|---|---|---|
| Bupivacain | Active comparator | Not described Receives: Drug: bipuvacain |
| Sodium Chloride | Sham comparator | Not described Receives: Other: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain indicated on VAS at specific time intervals during the induction to expulsion
Measured: at 24 hours
Secondary outcomes (3)
Efficacy
Number of complete abortions within 24h without the need for surgery
Measured: after 24h from induction
Time to abortion
Time from induction (first dose of misoprostol) to expulsion
Measured: 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
Measured: at 6 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Second Trimester Medical AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristina Gemzell Danielsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristina Gemzell Danielsson, Karolinska Institutet
- Investigators
- Kristina Gemzell Danielsson, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617564
- Sponsor's protocol ID
- W2010IM
- Status last verified
- May 2015
- First submitted
- 31 May 2012
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26573530
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracervical Block (PCB) During II-trimester Abortion- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01617564
- Acronym / sponsor ID
- W2010IM
- Conditions
- Second Trimester Medical Abortion
- Keywords
- medical abortion, second trimester, para cervical blockage, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Kristina Gemzell DanielssonUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Paracervical blockage can reduce severe pain during second trimester induced medical abortion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacain | Active comparator | Drug: bipuvacain |
| Sodium Chloride | Sham comparator | Other: NaCl |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Known allergy to bupivakain or related substances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bipuvacainAlso: (Marcain® 2,5mg/ml)PCB with 20ml bupivakain or sodium cloride 9mg/ml will be administered one hour following misorpostol administration (first dose). | Drug | Bupivacain |
| NaClPCB with 20ml sodium chloride (9mg/ml) inactive (sham) comparator | Other | Sodium Chloride |
Primary outcome
Pain score
Time frame: at 24 hours
Pain indicated on VAS at specific time intervals during the induction to expulsion
3 secondary outcomes
Efficacy
Time frame: after 24h from induction
Time to abortion
Time frame: at 24hours
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: at 6 to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
- Derived from this study: PubMed 26573530Andersson 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.
Related trials for Second Trimester Medical Abortion
Not yet recruitingPhase 1/2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
Abortion Induced Complicated, Abortion
Recruiting
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Abortion, Second Trimester, Abortion, Medical
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Gemzell Danielsson, MD, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bipuvacain and NaCl in people with Second Trimester Medical Abortion, run by Kristina Gemzell Danielsson at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: at 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01617564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2015.