Pregnancy RelatedNCT06800287
Pharmacological Voluntary Termination of Pregnancy: Predictors of Pelvic Pain During Treatment
An observational study of Pregnancy Related, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial summary
Pharmacological treatment for voluntary termination of pregnancy is a safe and effective practice, but has as its limitation a greater need for analgesic coverage than surgical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- How many people
- 13 participants
- Where
- 2 sitesItaly
- Study dates
- 13 Jul 2021to 25 Nov 2024
- Phase
- Observational
- 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
Study population: Patients requesting a pharmacological voluntary termination of pregnancy, according to Law 194 of 1978
Who may be able to join
- Patients over 18 years of age
- IVG certificate issued by the doctor and signed by the woman
- Informed consent for drug treatment
- Informed consent for the study in question
- Pregnancy in utero with ultrasound date less than or equal to 63 days
Who cannot join
- Suspected extrauterine pregnancy or adnexal masses of undefined diagnosis
- IUD in place
- Severe anaemia
- Hereditary porphyria
- Coagulopathy or ongoing treatment with anticoagulants
- Ongoing treatment with corticosteroids or adrenal insufficiency
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda USL di Bologna
Bologna, Bologna, 40138
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
About this study
Official title: Prospective Observational Study On Pharmacological Voluntary Termination Of Pregnancy: Predictors Of Pelvic Pain During Treatment
Pharmacological treatment for voluntary termination of pregnancy is a safe and effective practice, but has as its limitation a greater need for analgesic coverage than surgical treatment. Despite this, to date there are no specific guidelines on the management of pain therapy during pharmacological voluntary termination of pregnancy and in particular on its correlation with gestational age at the time of treatment. The aim of the study is to investigate the correlation between the pain symptoms reported by the patients and the gestational age at the time of the pharmacological voluntary interruption of pregnancy and to identify the presence of possible predictive factors, in order to be able to outline the correct therapeutic management.
Read the detailed description
According to the Law 194 of 1978, in Italy the voluntary interruption of pregnancy (IVG) can be requested by the woman within the first 90 days of gestation for health reasons, economic, social or family. Voluntary termination of pregnancy may be achieved by surgical or pharmacological treatment.
The surgical treatment involves hysteroaspiration associated with instrumental revision of uterine cavity (RCU).
The drug treatment involves administration of mifepristone (known as RU486), followed by approximately 48 hours after administration of prostaglandins. The World Health Organization in a 2003 publication, updated in 2012, has indicated mifepristone as one of the pharmacological treatments for IVG in the first 9 weeks of gestation. Since July 2009, the AIFA has authorised its marketing in Italy. The choice between the two treatments depends on the gestational age and the patient's preferences, after careful counselling with the gynecologist, about the risks and benefits of both procedures.
In particular, until a few months ago, pharmacological treatment was reserved in Italy exclusively for patients who required IVG within the 49° day of amenorrhea. Beyond this threshold, and within the 90 days of gestation, IVG was allowed only with surgical treatment.
The Ministry of Health on 12 August 2020 issued the circular "Guidelines on voluntary termination of pregnancy with mifepristone and prostaglandins", updating the previous one dated 24 June 2010.
Based on this update, voluntary termination of pregnancy with a pharmacological method is possible up to 63 days, equal to 9 weeks completed, gestational age.
Pharmacological treatment is allowed in adequately equipped public outpatient facilities, functionally connected to the hospital and authorised by the Region, as well as in day hospitals (DH).
Drug treatment is a safe and effective practice, but it has as its limit a greater need for analgesic coverage than surgical treatment.
Many women report it as an extremely painful experience. Despite this, there are no specific guidelines on the management of pain relief therapy in the course of pharmacological IVG and in particular on its correlation with the gestational age at the time of IVG.
The aim of this study is to investigate the correlation between the painful symptoms reported by patients and the gestational age at the time of IVG and to identify the presence of any predictive factors, in order to outline the correct therapeutic management.
- Conditions
- Pregnancy Related
- Keywords
- pelvic pain, ivg, predictive factors, pregnancy, voluntary interruption of pregnancy, pharmacological treatment
- Medical subject headings
- Pelvic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain symptoms of patients undergoing pharmacological IVG
Assessing the pain symptoms of patients undergoing pharmacological IVG recorded according to the Visual Analog Scale (VAS) scale and the need for additional analgesic therapy (rescue dose), in relation to certain variables such as the patient's age, gestational age, anxiety trait and pre-procedure anxiety state of the patients assessed by means of scientifically validated questionnaires.
- VAS questionnaire: 0-100 numeric scale to record the patient's pain symptoms. 0 is considered the absence of pain, ≤ 40 tolerable pain (not requiring supplementary therapy), > 40 ≤ 70 intense pain (responsive to required supplementary therapy), > 70 intolerable pain not responsive to required supplementary therapy, 100 maximum pain perceived in the patient's life.
Measured: 48 hours after the administration of mifepristone and after an observation period of not less than 3 hours
Secondary outcomes (1)
Patient satisfaction
Assessing patient satisfaction by administering a questionnaire: 0-4 numerical scale to record the patient's degree of satisfaction. It is considered 0 not at all satisfied, 1 slightly satisfied, 2 fairly satisfied, 3 very satisfied, 4 completely satisfied.
Measured: 48 hours after the administration of mifepristone and after an observation period of not less than 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start13 Jul 2021
- Primary completion30 Apr 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renato Seracchioli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800287
- Sponsor's protocol ID
- IVG - OS
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study On Pharmacological Voluntary Termination Of Pregnancy: Predictors Of Pelvic Pain During Treatment
- ClinicalTrials.gov ID
- NCT06800287
- Acronym / sponsor ID
- IVG - OS
- Conditions
- Pregnancy Related
- Keywords
- pelvic pain, ivg, predictive factors, pregnancy, voluntary interruption of pregnancy, pharmacological treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 30 Jan 2025 (actual)
- 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.
Pharmacological treatment for voluntary termination of pregnancy is a safe and effective practice, but has as its limitation a greater need for analgesic coverage than surgical treatment. Despite this, to date there are no specific guidelines on the management of pain therapy during pharmacological voluntary termination of pregnancy and in particular on its correlation with gestational age at the time of treatment. The aim of the study is to investigate the correlation between the pain symptoms reported by the patients and the gestational age at the time of the pharmacological voluntary interruption of pregnancy and to identify the presence of possible predictive factors, in order to be able to outline the correct therapeutic management.
Detailed description
According to the Law 194 of 1978, in Italy the voluntary interruption of pregnancy (IVG) can be requested by the woman within the first 90 days of gestation for health reasons, economic, social or family. Voluntary termination of pregnancy may be achieved by surgical or pharmacological treatment.
The surgical treatment involves hysteroaspiration associated with instrumental revision of uterine cavity (RCU).
The drug treatment involves administration of mifepristone (known as RU486), followed by approximately 48 hours after administration of prostaglandins. The World Health Organization in a 2003 publication, updated in 2012, has indicated mifepristone as one of the pharmacological treatments for IVG in the first 9 weeks of gestation. Since July 2009, the AIFA has authorised its marketing in Italy. The choice between the two treatments depends on the gestational age and the patient's preferences, after careful counselling with the gynecologist, about the risks and benefits of both procedures.
In particular, until a few months ago, pharmacological treatment was reserved in Italy exclusively for patients who required IVG within the 49° day of amenorrhea. Beyond this threshold, and within the 90 days of gestation, IVG was allowed only with surgical treatment.
The Ministry of Health on 12 August 2020 issued the circular "Guidelines on voluntary termination of pregnancy with mifepristone and prostaglandins", updating the previous one dated 24 June 2010.
Based on this update, voluntary termination of pregnancy with a pharmacological method is possible up to 63 days, equal to 9 weeks completed, gestational age.
Pharmacological treatment is allowed in adequately equipped public outpatient facilities, functionally connected to the hospital and authorised by the Region, as well as in day hospitals (DH).
Drug treatment is a safe and effective practice, but it has as its limit a greater need for analgesic coverage than surgical treatment.
Many women report it as an extremely painful experience. Despite this, there are no specific guidelines on the management of pain relief therapy in the course of pharmacological IVG and in particular on its correlation with the gestational age at the time of IVG.
The aim of this study is to investigate the correlation between the painful symptoms reported by patients and the gestational age at the time of IVG and to identify the presence of any predictive factors, in order to outline the correct therapeutic management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requesting a pharmacological voluntary termination of pregnancy, according to Law 194 of 1978
Key inclusion criteria (5 listed)
- Patients over 18 years of age
- IVG certificate issued by the doctor and signed by the woman
- Informed consent for drug treatment
- Informed consent for the study in question
- Pregnancy in utero with ultrasound date less than or equal to 63 days
Key exclusion criteria (6 listed)
- Suspected extrauterine pregnancy or adnexal masses of undefined diagnosis
- IUD in place
- Severe anaemia
- Hereditary porphyria
- Coagulopathy or ongoing treatment with anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain symptoms of patients undergoing pharmacological IVG
Time frame: 48 hours after the administration of mifepristone and after an observation period of not less than 3 hours
Assessing the pain symptoms of patients undergoing pharmacological IVG recorded according to the Visual Analog Scale (VAS) scale and the need for additional analgesic therapy (rescue dose), in relation to certain variables such as the patient's age, gestational age, anxiety trait and pre-procedure anxiety state of the patients assessed by means of scientifically validated questionnaires. - VAS questionnaire: 0-100 numeric scale to record the patient's pain symptoms. 0 is considered the absence of pain, ≤ 40 tolerable pain (not requiring supplementary therapy), > 40 ≤ 70 intense pain (responsive to required supplementary therapy), > 70 intolerable pain not responsive to required supplementary therapy, 100 maximum pain perceived in the patient's life.
1 secondary outcome
Patient satisfaction
Time frame: 48 hours after the administration of mifepristone and after an observation period of not less than 3 hours
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 30 Jan 2025.
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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.
Renato Seracchioli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
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 6 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 30 Jan 2025. 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 Italy. 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?
Pain symptoms of patients undergoing pharmacological IVG (time frame: 48 hours after the administration of mifepristone and after an observation period of not less than 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2025.