Medical Abortion up to 10 Weeks Gestation at Home

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

273 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2021-12-31

Brief Summary

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Medical abortion performed in the womens home has shown to be safe and acceptable up to 9 weeks of gestation. Our project is aiming to confirm our hypothesis that it is equally effective, safe and acceptable when the gestation is more advanced, up to 10 weeks of gestation.

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Detailed Description

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The study will include 600 women opting for medical abortion. Women wanting to perform the last part of the abortion in their homes will be invited to participate. 300 women with a pregnancy up to 9 weeks of gestation (63 days) will be compared to 300 women with a gestation length between 64 and 70 days of gestation. The primary endpoints will be number of patients with an incomplete abortion, with a need for surgical or pharmaceutical intervention.

Secondary endpoints include duration of bleeding, acceptance and satisfaction with the method and number of additional visits to the clinic/facility.

The study will be performed in five abortion clinics in Sweden.

Conditions

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Pregnancy Complications Legally Induced Abortion Without Mention of Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gestational length up to 63 days

Medical abortion at home using 200 mg of Mifepristone orally at the clinic followed by 0.8 mg Cytotec vaginally at home 48 hours later

Medical abortion at home

Intervention Type PROCEDURE

Medical abortion using Mifepristone at the clinic followed by Cytotec at home

Gestational length 64-70 days

Medical abortion at home using 200 mg of Mifepristone orally at the clinic followed by 0.8 mg Cytotec vaginally at home 48 hours later

Medical abortion at home

Intervention Type PROCEDURE

Medical abortion using Mifepristone at the clinic followed by Cytotec at home

Interventions

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Medical abortion at home

Medical abortion using Mifepristone at the clinic followed by Cytotec at home

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Requesting and eligible for medical abortion
* Confirmed intrauterine pregnancy
* Gestational length no more than 70 days
* Hemoglobin over 100g/l

Exclusion Criteria

* Anemia
* Contraindication to mifepristone (steroid-dependant cancer, porphyria)
* Breast feeding
* Advanced pregnancy (\>70 days)
* Known liver disease
* Bleeding disorder
* Arterial hypertension

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No