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OpenTrials
Completed

NCT Number: NCT00674232

Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment

This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.

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Key information

Conditions

Incomplete Abortion Abortion, Incomplete Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Gineco-obstetrico Isidro Ayora, Quito, Ecuador

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • past or present history of vaginal bleeding during pregnancy
  • open cervical os
  • evidence of incomplete abortion with substantial debris in the uterus (if using ultrasound)
  • surgical evacuation of the uterus would be advised as course of action if misoprostol was not available
  • generally in good health
  • woman lives or works within one hour of study site
  • woman willing to provide contact information for follow up purposes
  • informed consent given

Exclusion criteria

  • contraindications to study drug
  • uterine size larger than 12 weeks LMP
  • signs of severe infection

Treatment and study plan

600 mcg misoprostol

Drug

single dose of misoprostol taken orally

Other names: Cytotec

surgical treatment

Procedure

Either dilation and curettage or manual vacuum aspiration, as per local protocol

Other names: D&C, MVA

Primary outcomes

  1. complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason

    Time frame: one week after initial treatment

Secondary outcomes

  1. side effects

    Time frame: measured at follow up visit one week after initial treatment

  2. acceptability

    Time frame: measured at follow up visit one week after initial treatment

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

Misoprostol for Treatment of Incomplete Abortion

Important dates

Study start
2006
Study completion
2007
First posted
May 7, 2008
Registry last updated
May 7, 2008

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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