Pain and Medical Abortion Among Teenaged Women Compared to Adult Women

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Oxynorm on-demand; Drug: Oxynorm via PCA

• Registration Number: NCT02678897
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-10
• Study Start: 2016-03
• Primary Completion: 2018-08
• Study Completion: 2018-08-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 242

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxynorm on-demand	Oxynorm on-demand	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.
Patient controlled analgesia (PCA)	Oxynorm via PCA	Pregnancy weeks 9-20. All patients get baselineanalgesics: Ibuprofein 600mg and Paracetamol 1000mg both x3 a day. Patients get pain medication (Oxynorm) via PCA

Primary Outcome Measures

Name	Time	Method
Patients are less painful using patient controlled analgesia (PCA)	During drug-induced abortion, in hospital care (1-2days)	Measured in visual analog scale (VAS, 0-100mm). VAS is lower.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction is higher	just after the abortion and 2-3 weeks after in follow-up visit	Measured in visual analog scale (VAS, 0-100mm), VAS is higher.

Trial Locations

Locations (2)

Helsinki University Central hospital, Kätilöopistohospital; 🇫🇮 Helsinki, HUS, Finland

Helsinki University central hospital, Naistenklinikka; 🇫🇮 Helsinki, HUS, Finland