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Completed

NCT Number: NCT01856985

Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered at 78-84 Days Gestation

These pilot studies are designed as open label studies to investigate the acceptability of 200 mg mifepristone followed 24-48 hours later by either 1) 800 µg misoprostol administered buccally or 2) 800 µg misoprostol administered sublingually for medical abortion in gestations 78-84 days' LMP. They will be done consecutively.

Findings from the pilot studies will guide the development of a larger, multi-site study to investigate the efficacy of outpatient medical abortion regimens for women with gestations from 78 - 84 days LMP. In that end, the pilots seek to collect information on the acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable? Women's rating of the tolerability of any side effects will also be documented.

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Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hung Vuong Hospital

Ho Chi Minh City, Vietnam

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Seeking abortion services
  • Have an intrauterine pregnancy 78 days through 84 days' LMP
  • Be willing and able to sign consent forms
  • Agree to comply with study procedures and visit schedule
  • Be living with 30 minutes from the hospital

Exclusion criteria

  • Does not meet the inclusion criteria outlined above

Treatment and study plan

Misoprostol

Drug

Mifepristone

Drug

Primary outcomes

  1. Percentage of women who have undergone a successful abortion

    Time frame: 2 weeks

Secondary outcomes

  1. Women's acceptability of the assigned method.

    Time frame: 2 weeks

  2. Side effects

    Time frame: 48 hours

    Side effects include nausea, vomiting, pain, diarrhea, fever. Asked women to rank as none, mild, moderate, severe. Used an acceptability scale (Very Acceptable v. Acceptable v. Neutral v. Unacceptable v. Very unacceptable v. Don't know) to ascertain acceptability among women

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

The Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered Buccally or Sublingually at 78-84 Days Gestation: Two Pilot Studies

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 20, 2013
Registry last updated
Oct 11, 2013

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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