An interventional study of misprostol and UnijectTM in Postpartum Hemorrhage, sponsored by Gynuity Health Projects. Withdrawn at 1 site in Mali. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-09.
Sponsored by Gynuity Health Projects · Not applicable, Interventional, and Prevention
This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.
This study will assess the programmatic implications (including feasibility, acceptability, costs, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.
445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.
Browse Postpartum Hemorrhage studies →Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
600 mcg oral misoprostol administered during the third stage of labor
Drug: misprostol
10 IU oxytocin delivered IM with UnijectTM during he third stage of labor
Device: UnijectTM
600 mcg misoprostol oral
Also known as: Cytotec
10 IU oxytocin delivered intramuscularly with UnijectTM
Mean change in hemoglobin
To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible.
Time frame: during 3rd trimester and 1-3 days postpartum
occurrence and management of side effects
nausea, vomiting, diarrhea, shivering, fever
Time frame: 1 hour postpartum
correct timing of drug administration
administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta
Time frame: collected immediately following birth, verified 1-3 days postpartum
change in hemoglobin ≥ 2 g/dL
Time frame: during third trimester and 1-3 days postpartum
additional interventions
use of additional uterotonics, manual removal of placental fragments, etc
Time frame: during birth and 1-3 days postpartum
referrals
referral requested, transfers carried out, reasons for incomplete referrals/transfers
Time frame: 1-3 days postpartum
acceptability
acceptability according to woman of study medication, care received, side effects experienced
Time frame: 1-3 days postpartum
This study is withdrawn, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Gynuity Health Projects