Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003760-36 | EudraCT Number | ||
| 2015-005657-12 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Helsinki | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this two-parted study the need and sufficiency of analgesics and experienced pain is compared between teen-aged and adult women undergoing medical termination of pregnancy (MToP)in early pregnancy (under 9weeks of gestation). During MToP at pregnancy weeks 9-20 on-demand administration of opiates and patient-controlled analgesia (PCA) are compared in randomized clinical trial.
Adequate pain control is crucial in medical abortion. Experience of painful and traumatic abortion can affect patients future plans on pregnancy and childbirth. Study's purpose is to investigate only pain experience and pain management. Otherwise the care of abortion is according to present Finnish national guideline.
Study's goal is to evaluate experienced pain and the need and adequacy of analgesics and to obtain more efficient analgesics during MToP. In addition investigators hope to recognize predicting factors of severe pain.
Study is done in cooperation with Helsinki university and Helsinki university central hospital and is accomplished in Womens hospital and Kätilöopisto hospital in which care of abortions is centralized in HUS area.
Altogether 340 women, who are primigravid, aged between 15-19 or 25-35 years and tolerate used analgesics, are recruited in the study. MToP is done with the combination on mifepristone 200mg and misoprostol 800ug according to Finnish national guidelines. Baseline analgesics are Ibuprofein 600mg ja Paracetamol 1000mg, both three times a day and first dose is taken simultaneously with Misoprostol.
First part is a prospective study in which we compare pain experience and sufficiency of analgesics during MToP in early pregnancy (under 9 weeks of pregnancy). Pain is measured by VAS, which is reported in a diary every time analgesics are needed.
Second part is a controlled randomized study with PCA and on-demand pain management during medical termination of pregnancy with gestational age of 9 to 20 weeks. Every teen-aged woman has two adult controls.
Against severe pain patients get Opiates (oxycodone). In intervention group patients get PCA with Oxycodon dose of 3.0 mg maximal four times in an hour. In control group Oxycodon is administrated on demand po, im or iv depending on the intensity of pain. Pain is measured by VAS from the onset of pain and repeated every 30 minutes until fetal expulsion.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain management in early pregnancy MTOP | No Intervention | Patients in early pregnancy (pregnancy weeks <9weeks) undergoing medical termination of pregnancy gets Ibuprofen (tbl 600mg 3 times a day) and Paracetamol (tbl 1000mg 3 times a day). | |
| Patient controlled analgesia (PCA) | Experimental | Pregnancy weeks 9-20. All patients get baselineanalgesics: Ibuprofein 600mg and Paracetamol 1000mg both x3 a day. Patients get pain medication (Oxynorm) via PCA |
|
| Oxynorm on-demand | Active Comparator | Pregnancy weeks 9-20. All patients get baselineanalgesics: Ibuprofein 600mg and Paracetamol 1000mg both x3 a day. Patients get extra pain medication (Oxynorm) on-demad from the nurse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxynorm on-demand | Drug | We compare different routes of administration (PCA an oral/intramuscular use of oxynorm) in patients undergoing medical termination of pregnancy. Patients are randomized in two groups (for extra pain medication)
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients are less painful using patient controlled analgesia (PCA) | Measured in visual analog scale (VAS, 0-100mm). VAS is lower. | During drug-induced abortion, in hospital care (1-2days) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction is higher | Measured in visual analog scale (VAS, 0-100mm), VAS is higher. | just after the abortion and 2-3 weeks after in follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Teen-aged women experience more severe pain than their adult comparators. | Measured: Age, visual analogue scale (pain-VAS) is higher during medical abortion. | during drug-induced abortion |
| Patients with history of dysmenorrhea or anxiety experience more severe pain during drug-induced abortion. |
Inclusion Criteria:
Exclusion criteria for inquiry part are
Exclusion criteria for intervention part are
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Oskari Heikinheimo, Professor | Helsinki University Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central hospital, Kätilöopistohospital | Helsinki | HUS | 00029 | Finland | ||
| Helsinki University central hospital, Naistenklinikka |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 28, 2021 | |
| Reset | Jun 21, 2021 | |
| Release | Jan 9, 2025 | |
| Reset | Feb 3, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 28, 2021 | Jun 21, 2021 | |||
| Jan 9, 2025 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Oxynorm via PCA | Drug | We compare different routes of administration (PCA an oral/intramuscular use of oxynorm) in patients undergoing medical termination of pregnancy. Patients are randomized in two groups (for extra pain medication)
|
|
VAS-scale asked about pain during menstrual bleeding, Anxiety questionnaire (GHQ12, anxiety level is higrher) and Visual analogue scale (VAS) of pain during medical abortion is higher |
| During drug-induced abortion |
| Helsinki |
| HUS |
| 00029 |
| Finland |
| Feb 3, 2025 |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |