Surgical AbortionBPCENNCT03043014
Cervical Preparation of Abortions Under Paracervical Block in the First Trimester:
A study testing Mifépristone versus Misoprostol in people with Surgical Abortion, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Surgical abortion is one of the most frequently surgery of women in the world. 43 millions are annually performed in the world. 90% of the abortions are performed during the first trimester of pregnancy before 13 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Abortion
- What is being tested?
- Mifépristone versus Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2017to 15 Nov 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 or over with a single intra uterine pregnancy whose term is between 6 and 14 weeks the day of the abortion estimated by ultrasound by a measurement of the cranio-caudal length between 5 and 84 millimeters surgical abortion under local anesthesia informed written consent
Who cannot join
- minor multiple pregnancy Uterine malformation coagulation disorder defined by biological parameters (TP<70%, TCA patient / control ratio < 1.20) Allergy or hypersensitivity to any of the active substance or to any of the excipients Contraindication to mifepristone chronic renal insufficiency severe asthma uncontrolled by treatment hereditary porphyria allergy to the active substance or to any of the excipients; not affiliated to the social security system; no informed consent. Suspicion of ectopic pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de la conception Assistance Publique Hôpitaux de Marseille
Marseille
About this study
Official title: Cervical Preparation of Abortions Under Paracervical Block in the First Trimester: A Randomized Clinical Trial
Surgical abortion is one of the most frequently surgery of women in the world. 43 millions are annually performed in the world.
90% of the abortions are performed during the first trimester of pregnancy before 13 weeks. Legal surgical abortion during the first trimester of pregnancy is a low risk intervention with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 % to 3.4 %.
Read the detailed description
Surgical abortion is one of the most frequently surgery of women in the world. 43 millions are annually performed in the world.
Legal surgical abortion during the first trimester of pregnancy is a low risk intervention with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 % to 3.4 %. In France, about 75 % of the surgical abortions are performed under general anesthesia (GA). Nevertheless, the risk of complications is higher under GA. The risk of death is more important (0,58 for 100 000) with GA. GA increases by a factor 1,7 the risk of bleeding, 2,2 the risk of uterine perforation, 8,2 the risk of intra-abdominal bleeding, 2,9 the risk of cervical tearing, and 5 the risk of transfusion. The difficulty of pain control under local anesthetia (LA) explains this method is less choosen by the women. Indeed, a lot of women consider the surgical abortion under LA extremely uncomfortable. The paracervical block for the abortion under LA in the first trimester demonstrated its efficiency in the reduction of the per-operating pain whatever the term of the pregnancy compared with the absence of anesthesia. The cervical preparation demonstrated benefits in term of cervical dilation, per-operating bleeding, and complications incidence. The misoprostol and the mifepristone are 2 molecules recommended for the cervical preparation on the first trimester
- Conditions
- Surgical Abortion
- Being tested
- Mifépristone versus Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifépristone versus MisoprostolDrug
The women will be randomized into two groups: Mifépristone group and Misoprostol group. The main endpoint will be the per-operating pain. The other endpoints are the pre and post-operative pain, the complications (cervical tearing, uterine perforation, hemorrhage requiring the use of blood products or an hemostatic intervention), the surgical time necessary to terminate the pregnancy, the side-effects of the drugs. The amount of per-operating bleeding and the duration of the intervention . The investigators assume that the use of Mifepristone in the cervical preparation of the surgical abortion under LA would reduce the per-operating pain. The number of patients required is 55 in each arm.
| Study group | Role | What they receive |
|---|---|---|
| Mifépristone group | Experimental | Not described Receives: Drug: Mifépristone versus Misoprostol |
| misoprostol group | Active comparator | Not described Receives: Drug: Mifépristone versus Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
per operative pain
It is carried out using a numerical scale rated from 0 to 10 (0 absence of pain, 10 maximum of pains felt).
Measured: 20 minutes
Anxiety
STAI anxiety questionnaire;it is a self-questionnaire, developed by Spielberger (Spielberger, 1983) and validated in French (Gauthier \& Bouchard, 1993). It consists of 20 questions, assessing the usual emotional state of the subject. A score is calculated, a high score indicating the presence of anxiety.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Jun 2017
- Primary completion13 Mar 2019
- Study completion15 Nov 2022
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 Surgical AbortionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- The women will be randomized into two groups: Mifépristone group and Misoprostol group. The main endpoint will be the per-operating pain. The other endpoints are the pre and post-operative pain, the complications (cervical tearing, uterine perforation, hemorrhage requiring the use of blood products or an hemostatic intervention), the surgical time necessary to terminate the pregnancy, the side-effects of the drugs. The amount of per-operating bleeding and the duration of the intervention . We assume that the use of Mifepristone in the cervical preparation of the surgical abortion under LA would reduce the per-operating pain. The number of patients required is 55 in each arm.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043014
- Sponsor's protocol ID
- 2016-35
- Acronym
- BPCEN
- Status last verified
- Nov 2019
- First submitted
- 25 Jan 2017
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamdaoui N, Cardinale C, Fabre C, Baumstarck K, Agostini A. Pain Associated With Cervical Priming for First-Trimester Surgical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):1055-1060. doi: 10.1097/AOG.0000000000004376.
PubMed 33957651
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Preparation of Abortions Under Paracervical Block in the First Trimester: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03043014
- Acronym / sponsor ID
- BPCEN / 2016-35
- Conditions
- Surgical Abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 3 Feb 2017 (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.
Surgical abortion is one of the most frequently surgery of women in the world. 43 millions are annually performed in the world.
90% of the abortions are performed during the first trimester of pregnancy before 13 weeks. Legal surgical abortion during the first trimester of pregnancy is a low risk intervention with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 % to 3.4 %.
Detailed description
Surgical abortion is one of the most frequently surgery of women in the world. 43 millions are annually performed in the world.
Legal surgical abortion during the first trimester of pregnancy is a low risk intervention with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 % to 3.4 %. In France, about 75 % of the surgical abortions are performed under general anesthesia (GA). Nevertheless, the risk of complications is higher under GA. The risk of death is more important (0,58 for 100 000) with GA. GA increases by a factor 1,7 the risk of bleeding, 2,2 the risk of uterine perforation, 8,2 the risk of intra-abdominal bleeding, 2,9 the risk of cervical tearing, and 5 the risk of transfusion. The difficulty of pain control under local anesthetia (LA) explains this method is less choosen by the women. Indeed, a lot of women consider the surgical abortion under LA extremely uncomfortable. The paracervical block for the abortion under LA in the first trimester demonstrated its efficiency in the reduction of the per-operating pain whatever the term of the pregnancy compared with the absence of anesthesia. The cervical preparation demonstrated benefits in term of cervical dilation, per-operating bleeding, and complications incidence. The misoprostol and the mifepristone are 2 molecules recommended for the cervical preparation on the first trimester
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The women will be randomized into two groups: Mifépristone group and Misoprostol group. The main endpoint will be the per-operating pain. The other endpoints are the pre and post-operative pain, the complications (cervical tearing, uterine perforation, hemorrhage requiring the use of blood products or an hemostatic intervention), the surgical time necessary to terminate the pregnancy, the side-effects of the drugs. The amount of per-operating bleeding and the duration of the intervention . We assume that the use of Mifepristone in the cervical preparation of the surgical abortion under LA would reduce the per-operating pain. The number of patients required is 55 in each arm.
| Arm | Type | Receives |
|---|---|---|
| Mifépristone group | Experimental | Drug: Mifépristone versus Misoprostol |
| misoprostol group | Active comparator | Drug: Mifépristone versus Misoprostol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 18 or over with a single intra uterine pregnancy whose term is between 6 and 14 weeks the day of the abortion estimated by ultrasound by a measurement of the cranio-caudal length between 5 and 84 millimeters surgical abortion under local anesthesia informed written consent
Key exclusion criteria (1 listed)
- minor multiple pregnancy Uterine malformation coagulation disorder defined by biological parameters (TP<70%, TCA patient / control ratio < 1.20) Allergy or hypersensitivity to any of the active substance or to any of the excipients Contraindication to mifepristone chronic renal insufficiency severe asthma uncontrolled by treatment hereditary porphyria allergy to the active substance or to any of the excipients; not affiliated to the social security system; no informed consent. Suspicion of ectopic pregnancy
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 |
|---|---|---|
| Mifépristone versus MisoprostolThe women will be randomized into two groups: Mifépristone group and Misoprostol group. The main endpoint will be the per-operating pain. The other endpoints are the pre and post-operative pain, the complications (cervical tearing, uterine perforation, hemorrhage requiring the use of blood products or an hemostatic intervention), the surgical time necessary to terminate the pregnancy, the side-effects of the drugs. The amount of per-operating bleeding and the duration of the intervention . The investigators assume that the use of Mifepristone in the cervical preparation of the surgical abortion under LA would reduce the per-operating pain. The number of patients required is 55 in each arm. | Drug | Mifépristone group, misoprostol group |
Primary outcome
per operative pain
Time frame: 20 minutes
It is carried out using a numerical scale rated from 0 to 10 (0 absence of pain, 10 maximum of pains felt).
Anxiety
Time frame: 48 hours
STAI anxiety questionnaire;it is a self-questionnaire, developed by Spielberger (Spielberger, 1983) and validated in French (Gauthier \& Bouchard, 1993). It consists of 20 questions, assessing the usual emotional state of the subject. A score is calculated, a high score indicating the presence of anxiety.
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 16 Nov 2022.
- Derived from this study: PubMed 33957651Hamdaoui N, Cardinale C, Fabre C, Baumstarck K, Agostini A. Pain Associated With Cervical Priming for First-Trimester Surgical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):1055-1060. doi: 10.1097/AOG.0000000000004376.
- Individual participant dataSharing planned: No
Related trials for Surgical Abortion
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The Effect of Music Therapy Under Ultrasound Guided Manual Vacuum Aspiration
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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.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mifépristone versus Misoprostol in people with Surgical Abortion, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 1 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 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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?
per operative pain (time frame: 20 minutes). The study lists 2 primary outcomes in all. 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 NCT03043014, 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 16 Nov 2022.