An interventional study of misoprostol and MVA in Abortion, Incomplete, sponsored by Gynuity Health Projects. Completed at 6 sites in 5 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-27.
Sponsored by Gynuity Health Projects · Not applicable, Interventional, and Treatment
This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion.
Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens:
In Tanzania and Mozambique:
In Moldova and Madagascar:
In Burkina Faso and Vietnam:
We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.
24 studies on the registry are indexed under Abortion, Incomplete; 5 are open to participants now.
This study's enrollment of 720 is above the median of 311 across 21 interventional studies indexed under Abortion, Incomplete.
Browse Abortion, Incomplete studies →Gynuity Health Projects is the lead sponsor of 113 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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If no ultrasound used:
If ultrasound used:
All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
Willing to provide contact information for purposes of follow-up.
Exclusion Criteria:
Signs of severe infection, defined as at least one of the following of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treatment with 600mcg oral misoprostol
Drug: misoprostol
treatment with 400mcg sublingual misoprostol
Drug: misoprostol
treatment with Manual Vacuum Aspiration (MVA)
Procedure: MVA
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
Also known as: Cytotec
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
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 with the option of an additional week
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Misoprostol