Pain and Medical Abortion Among Teenaged Women Compared to Adult Women

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Oxynorm via PCA; Drug: Oxynorm on-demand

Study type: Interventional

Funder types: Other

Identifiers

NCT02678897

2015-003760-36 (EudraCT Number)

2015-005657-12 (EudraCT Number)

HUS277/03/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 242 patients

Sex: Female

Ages: 15 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 3 patient groups

Pain management in early pregnancy MTOP

No Intervention group

Description:

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 group

Description:

Pregnancy weeks 9-20. All patients get baselineanalgesics: Ibuprofein 600mg and Paracetamol 1000mg both x3 a day. Patients get pain medication (Oxynorm) via PCA

Treatment:

Drug: Oxynorm via PCA

Oxynorm on-demand

Active Comparator group

Description:

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.

Treatment:

Drug: Oxynorm on-demand