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Completed

NCT Number: NCT00997347

The Extended Gestational Age Medical Abortion Study

This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual misoprostol for termination of pregnancy in existing outpatient early medical abortion services among women 57-63 days' versus 64-70 days' gestation.

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Key information

Conditions

Medical Abortion

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Zhordania Institute of Human Reproduction, Tbilisi, Georgia

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • intrauterine pregnancy of greater than 56 days and less than 71 days
  • eligible for medical abortion according to study doctor assessment
  • willing and able to sign consent forms
  • speak English or Spanish (in US sites); speak the local language(s) (in international sites)
  • agree to comply with the study procedures and visit schedule

Treatment and study plan

mifepristone and misoprostol

Drug

200 mg oral mifepristone

800 mcg buccal misoprostol or 400 mcg sublingual misoprostol 24-48 hours after mifepristone

Primary outcomes

  1. Efficacy: Proportion of women who successfully complete abortion without surgical intervention to resolve viable pregnancy or incomplete abortion

    Time frame: 7-36 days

Secondary outcomes

  1. Proportion of individual side effects experienced by participants

    Time frame: 7-14 days

  2. Proportion of women who determined method acceptable (i.e., overall acceptability of method, time to abortion completion, bleeding, side effects, and pain)

    Time frame: 7-14 days

  3. Bleeding patterns, i.e. proportion of women who experienced heavy, moderate, or light bleeding according by day since abortion began

    Time frame: 7-14 days

  4. Average number of missed days of work or school due to the abortion procedure

    Time frame: 7-14 days

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

The Extended Gestational Age Medical Abortion Study: The Effectiveness of Medical Abortion With Mifepristone and Misoprostol at 57-63 Days Versus 64-70 Days Gestation

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 19, 2009
Registry last updated
Jul 2, 2012

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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