A Phase 3 interventional study of Misoprostol and Oxytocin in Postpartum Hemorrhage, sponsored by Jawaharlal Nehru Medical College. Completed at 1 site in India. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2011-06-14.
Sponsored by Jawaharlal Nehru Medical College · Phase 3, Interventional, and Prevention
Among 59 studies testing misoprostol in Postpartum Hemorrhage — 2 open to participants now, 2 under way, 1 of them phase 3. Misoprostol · Postpartum Hemorrhage.
Among the 59 studies testing misoprostol in Postpartum Hemorrhage, this one is the 13th largest by enrollment, is the only one that started in 2007, is one of 10 in phase 3, and was the 11th registered.
469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.
This study's enrollment of 652 is above the median of 148 across 360 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →2 of the 59 studies testing misoprostol in Postpartum Hemorrhage are open now, in 1 country. Each count lists the studies.
Misoprostol: first FDA approval 1988 (CYTOTEC). What it is approved for, and how studies give it, is on its page →
Of the 42 Postpartum Hemorrhage studies recruiting now, 21 (50%) set no upper age limit and 21 (50%) stop at 75 or younger; 6 take children under 18; 21 take healthy volunteers.
This study: 18 Years to 35 Years · female · no healthy volunteers.
The full table on the hub →59 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 1 started in 2007.
Median enrollment 240 across the 59 interventional studies. Of the 43 that completed or were terminated, 4 (9%) have results posted.
None of the 59 has an industry lead sponsor. The 10 most frequent:
Jawaharlal Nehru Medical College is the lead sponsor of 5 studies on the registry; none are open to participants now.
Jawaharlal Nehru Medical College has 1 study filed under Postpartum Hemorrhage — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 59 studies testing misoprostol in Postpartum Hemorrhage, from their registry updates:
Nothing recorded among them since 2026-09-25.
Sublingual misoprostol produces rapid peak concentration and is more effective than oral misoprostol for prevention of excessive postpartum bleeding. The study hypothesis was to test whether women receiving sublingual misoprostol for prevention of postpartum hemorrhage have 30 ml less average blood loss than women receiving oxytocin, the standard of care for prevention of postpartum hemorrhage. We conducted a Double blind randomized controlled trial of .652 consenting, eligible pregnant women admitted to the labor room of the teaching hospital at J N Medical College, Belgaum, India. Women participating in the study were assigned by computer generated randomization to receive the study medications and placebos within one minute after clamping and cutting the umbilical cord. We also looked at the drugs effects on postpartum blood loss at or above ≥500 ml (considered hemorrhage), and the percent of women experiencing more than a 10% decline in haemoglobin, and reported drug side effects.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
400 µg powdered misoprostol administered sublingually; IM placebo
Drug: Misoprostol
10 IU IM oxytocin; placebo powder
Drug: Oxytocin
400 µg sublingual misoprostol
10 IU IM
mean blood loss
Blood loss was objectively measured using the BRASSS-V DrapeTM, placed under the buttock before the delivery. The calibrated blood collection receptacle was opened after the delivery and drainage of amniotic fluid. Blood collected in the drape was transferred to measuring jar with 10 ml calibrations for accuracy. Blood soaked swabs were weighed in grams, and the known dry weight of the swabs was subtracted; this volume was added to the drape's measured blood volume (assuming 1 gm equivalence with 1 ml).
Time frame: 2 hours after delivery
postpartum hemorrhage (Blood loss >500 mls)
Blood loss was objectively measured using the BRASSS-V DrapeTM, placed under the buttock before the delivery. The calibrated blood collection receptacle was opened after the delivery and drainage of amniotic fluid. Blood collected in the drape was transferred to measuring jar with 10 ml calibrations for accuracy. Blood soaked swabs were weighed in grams, and the known dry weight of the swabs was subtracted; this volume was added to the drape's measured blood volume (assuming 1 gm equivalence with 1 ml).
Time frame: 2 hours after delivery
The percent of women experiencing a ≥10% postpartum decline in haemoglobin
Hemoglobin was obtained at presentation for delivery and again between 12 and 48 hours after delivery.
Time frame: At presentation for delivery and 12-48 hours after delivery
Medication side effects
Self reported side effects including nausea, vomiting, diarrhoea, abdominal pain, shivering and elevated temperature
Time frame: 2 hours after delivery
This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Misoprostol
Jawaharlal Nehru Medical College