Medical Abortion up to 10 Weeks Gestation at Home

NCT02191774 | Completed DMC

• 2 other identifiers: Marions 2014 1.22013-004749-18
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Complications; Legally Induced Abortion Without Mention of Complication

Keywords

Medical abortion; Home abortion

Outcome Measures

Primary Outcomes (1)

• Number of incomplete abortions

  Need for surgical or pharmaceutical intervention

  4 weeks after treatment

Secondary Outcomes (3)

• Duration of bleeding

  4 weeks after treatment

• Acceptance and satisfaction of treatment

  4 weeks after treatment

• Number of additional visits to the clinic

  4 weeks after treatment

Study Arms (2)

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

Procedure: Medical abortion 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

Procedure: Medical abortion at home

Interventions

Medical abortion at home PROCEDURE

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

Gestational length 64-70 days; Gestational length up to 63 days

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with an unwanted pregnancy opting for medical abortion

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Södersjukhuset

Stockholm, 118 83, Sweden

Location

Related Publications (1)

• Podolskyi V, Gemzell-Danielsson K, Maltzman LL, Marions L. Effectiveness and acceptability of home use of misoprostol for medical abortion up to 10 weeks of pregnancy. Acta Obstet Gynecol Scand. 2023 May;102(5):541-548. doi: 10.1111/aogs.14549. Epub 2023 Mar 18.

  PMID: 36933004 DERIVED

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Lena Marions, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, senior consultant

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 16, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)