Very Early Medical Abortion

Study Overview
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Brief Summary
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The research question begin addressed by this study is Is Very Early Medical Abortion (VEMA - before a pregnancy is visible on ultrasound scan) as effective as medical abortion when performed later and an intrauterine pregnancy can be visualised with ultrasound?. This is important to patients and public, because delays to abortion care can cause mental distress, and pain and bleeding are worse at later gestations. The study is examining whether earlier or delayed administration of abortion medications affects the efficacy and side effects of the medical abortion process, in women with very early pregnancies. Any women who had a positive pregnancy test, requesting abortion, but did not have a visible pregnancy on ultrasound scan could take part in the study. Women with signs, symptoms or ultrasound findings suggesting ectopic pregnancy would not be included. This study will be conducted at a community sexual and reproductive health centre that provides abortion care. The participants will be involved in the study for a maximum period of 4 weeks. They will be randomly allocated to either immediate abortion care or delayed abortion care. In each arm of the study they will receive clinical care that they would otherwise routinely receive. In addition to this, they will receive a telephone call follow up with a short questionnaire to complete over the phone. This study is being conducted in Scotland but the results will be combined with findings from similar research groups across Europe as part of a consortium of researchers. This consortium is coordinated by the Karolinska Institutet in Sweden under the EuDRACT ID: 2018-003675-35

Official Title
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Very Early Medical Abortion - a Randomised Controlled Trial

Conditions
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Abortion Early

Intervention / Treatment
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* Other: Immediate treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 years old or above opting for medical abortion with a pregnancy estimated by gynaecological history and Last Menstrual Period (LMP - if known) to be less than 6 weeks No signs of ectopic pregnancy, miscarriage or other pathological pregnancy Transvaginal ultrasound (part of the clinical protocol at the abortion visit) shows no confirmed Intrauterine Pregnancy (IUP see definitions below) Willing and able to return to the clinic for possible delayed treatment and at 1 to 2 weeks after the start of treatment for follow up Capable of giving their informed consent to participate. Exclusion Criteria: Women with visible (confirmed) IUP Women with contraindications to medical abortion including diagnosed pathological pregnancy at the initial examination. Inability to give informed consent. The following definitions will be used according to the consensus statement on nomenclature, definitions and outcomes in pregnancy of unknown location (Barnhart et al, Fertil Steril. 2011;95:857-66): Confirmed IUP: Ultrasound shows an intrauterine yolk sac or fetal structure with or without cardiac echo. Not confirmed IUP: This group includes cases where: ultrasound shows an empty uterine cavity (frequently referred to as PUL: Pregnancy of Unknown Location) or ultrasound shows a gestational sac, or sac like structure, but without a yolk sac.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VEMA<br>Immediate medical abortion treatment | Other: Immediate treatment<br>* Early Medical Abortion treatment, when ultrasound does not yet have conclusive signs of intrauterine pregnancy<br>|
| No Intervention: Standard of Care<br>Delayed care until an intrauterine pregnancy has been confirmed with ultrasound. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Abortion Rate (efficacy) | Rate of complete abortion without surgical intervention, as reported by patients using a self-administered low-sensitivity pregnancy test at 2 weeks after treatment. This will be collected via telephone questionnaire. | Within 30 days of treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rate | Rate of complications including ectopic pregnancy, infection. | Within 30 days of treatment initiation | 
| Duration of post-abortion bleeding | Number of days bleeding following treatment | Within 30 days of treatment initiation | 
| Acceptability of method | Preference for delay or immediate treatment | Within 30 days of treatment initiation | 
| Visual Analogue Pain score | Visual Analogue Scale of pain experienced during abortion. Mean will be reported and range of scale from 0-10. | Within 30 days of treatment initiation |