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Completed

NCT Number: NCT02191774

Medical Abortion up to 10 Weeks Gestation at Home

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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Key information

Conditions

Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Legally Induced Abortion Without Mention of Complication Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Södersjukhuset

Stockholm, 118 83, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical abortion at home

Procedure

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

Primary outcomes

  1. Number of incomplete abortions

    Time frame: 4 weeks after treatment

    Need for surgical or pharmaceutical intervention

Secondary outcomes

  1. Duration of bleeding

    Time frame: 4 weeks after treatment

    Measured by diary and questionnaires

  2. Acceptance and satisfaction of treatment

    Time frame: 4 weeks after treatment

    Questionnaires

  3. Number of additional visits to the clinic

    Time frame: 4 weeks after treatment

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2014
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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