Clinical trial NCT02678897: Pain and Medical Abortion Among Teenaged Women Compared to Adult Women
Official title: Pain and Medical Abortion - Predicting Factors of Pain and Optimal Pain Management Among Teenaged Women Compared to Adult Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Abortion, Drug-Induced
Pain Management
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2016-02-10
Enrollment: 242
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients who choose medical method of abortion
* First pregnancy
* Age between 15 and 19 years or 25 and 35 years
* Patients volunteer in the study

Exclusion criteria for inquiry part are

* Patient's serious illness
* Known allergy to one of the trial medications
* Abortion is done based on foetal abnormality or threat of patient's own health

Exclusion criteria for intervention part are

* Abortion is done based on foetal abnormality or threat of patient's own health
* Minor patient does not want to inform guardian
* More than one foetus
* Patient's serious illness (ASA-class 3 or 4)
* Massive obesity (BMI \>35 kg/m2)
* Known allergy to one of the trial medications
* History of opioid abuse
* Problems of understanding (Inability of use PCA or to understand VAS)
* Active bleeding before intake of first Misoprostol dose
* One of next medications: ketokonatsol, erythromycin, claritromycin, verapamil or diltiazem or medication against HIV (CYP3A4-transmitted interaction with oxycodon)

Primary outcomes:
measure: Patients are less painful using patient controlled analgesia (PCA)
timeFrame: During drug-induced abortion, in hospital care (1-2days)
Secondary outcomes:
measure: Patient satisfaction is higher
timeFrame: just after the abortion and 2-3 weeks after in follow-up visit
Other outcomes:
measure: Teen-aged women experience more severe pain than their adult comparators.
timeFrame: during drug-induced abortion
measure: Patients with history of dysmenorrhea or anxiety experience more severe pain during drug-induced abortion.
timeFrame: During drug-induced abortion
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central hospital, Kätilöopistohospital
state: HUS
city: Helsinki
country: Finland
facility: Helsinki University central hospital, Naistenklinikka
state: HUS
Study officials:
affiliation: Helsinki University Central Hospital
name: Oskari Heikinheimo, Professor
role: STUDY_DIRECTOR
References: