An interventional study of 600 mcg misoprostol and Surgical treatment in Incomplete Abortion, sponsored by Gynuity Health Projects. Completed at 3 sites in 2 countries. Open to female participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-05-07.
Sponsored by Gynuity Health Projects · Not applicable, Interventional, and 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.
24 studies on the registry are indexed under Abortion, Incomplete; 5 are open to participants now.
This study's enrollment of 311 is close to 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Group 1 randomized to take single dose of 600 mcg oral misoprostol
Drug: 600 mcg misoprostol
Group 2 randomized to receive standard surgical treatment as per local protocol (D\&C or MVA)
Procedure: Surgical treatment
single dose of misoprostol taken orally
Also known as: Cytotec
Either dilation and curettage or manual vacuum aspiration, as per local protocol
Also known as: D&C, 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
side effects
Time frame: measured at follow up visit one week after initial treatment
acceptability
Time frame: measured at follow up visit one week after initial treatment
The record gives a start of May 2006 and a completion of Oct 2007. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Misoprostol