Completed

NCT Number: NCT01768299

Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)

A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.

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Key information

Conditions

Complete Uterine Evacuation After Use of Study Drugs

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Binh duong Obstetrics and Newborn Hospital, Ho Chi Minh City, Binh Duong Province, Vietnam

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Closed cervical os and no vaginal bleeding
Live fetus at time of presentation for service
No contraindications to medical abortion and study procedures, according to provider
Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent
Willing to follow study procedures

Exclusion criteria

Known previous transmural uterine incision
> 5 parity
Signs and symptoms of infection
Any contraindications to vaginal delivery, including placenta previa
Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)

Treatment and study plan

Mifepristone

Drug

200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol

Misoprostol

Drug

200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol

Primary outcomes

Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention.

Time frame: Within 1 week

Defined as complete evacuation of fetus and placenta using study drug without recourse to any additional intervention.

Secondary outcomes

Induction to abortion interval

Time frame: Within 1 week

Defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus and placenta.
Women's acceptability of the assigned method.

Time frame: Within 1 week
Rate of fetal expulsion

Time frame: Within 1 week

Defined as fetal expulsion with study drug alone.
Provision of additional interventions

Time frame: Within 1 week

For example: Uterine massage, Manual removal, Sponge forceps, D&C or D&E, Repeat medical abortion drugs
Time interval from the mifepristone dose to abortion

Time frame: Within 1 week

Defined as length of time from initiation of mifepristone to complete abortion achieved.
Total dose of misoprostol administered

Time frame: Within 1 week

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks): A Double-blind Randomized-controlled Trial

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jan 15, 2013
Registry last updated: May 14, 2014

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.