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Pain and medical abortion

Pain an medical abortion -Predicting factors of pain and optimal pain management among teenaged women compared to adult women

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-003760-36-FI
Enrollment
200
Registered
2015-12-10
Start date
2016-01-20
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain during Medical termination of pregnancy

Interventions

Trade Name: oxynorm Product Name: oxynorm Pharmaceutical Form: Solution for injection/infusion Trade Name: oxanest Product Name: Oxanest Pharmaceutical Form: Solution for injection/infusion Trade Na

Sponsors

HUS - Naistentautien ja synnytysten tulosyksikkö
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients choosing medical abortion, are first time pregnant ag are aged between 15 to 19years and 25 to 35 years. Attending the study is voluntary Are the trial subjects under 18? yes Number of subjects for this age range: 65 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Abortion is done based on foetal abnormality or threat of patient's own health - More than one fetus -Patient's serious illness (ASA 3 or more) -BMI >35 kg/m2 -Known allergy to one of the trial drugs -History of opioid abuse -Problems of understanding

Design outcomes

Primary

MeasureTime frame
Main Objective: Adequate analgesia is crucial in patients undergoing medical abortion. We compare in controlled randomized trial pain management via PCA (patient controller analgesia) to our standard pain management in patients undergoing medical termination of pregnancy with gestational age over 9 weeks. In short we compare different administration routes of oxycodon. We hope to recognize those patients who benefit from more intensive pain management and to create guideline so that all patients receive adequate analgesia in the future.;Secondary Objective: Experience of painful and traumatic abortion may affect patients' future plans for pregnancies and childbirth. In addition this may lead patient to choose surgical abortion in case of reapportion, which exposes patient to operative risks.;Primary end point(s): Pain management via PCA is more effective (pain VAS is lower) and patient's satisfaction is higher. Teen-aged women profit more on effective pain management than their adult controls.;Timepoint(s) of evaluation of this end point: Collecting data takes about 1,5-2 years and is done by the end of the year 2017.

Secondary

MeasureTime frame
Secondary end point(s): Predicting factors of pain are patient's young age any longer duration of pregnancy.;Timepoint(s) of evaluation of this end point: Data is collected and ready to be evaluated in the end of the year 2017.

Countries

Finland

Contacts

Public ContactHUS

HUS - Naistentautien ja synnytysten tulosyksikkö

venla.kemppainen@hus.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026