Postpartum HemorrhagePhase 3NCT01373359
Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin
A Phase 3 study testing Misoprostol and Oxytocin in people with Postpartum Hemorrhage, run by Jawaharlal Nehru Medical College at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Misoprostol and Oxytocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 652 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2007to Jan 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with a gestational age >28weeks
- singleton pregnancy with cephalic presentation anticipating a normal spontaneous vaginal delivery (including episiotomy)
- a haemoglobin ≥ 8g/dl upon presentation who were admitted to labour room in the KLE teaching hospital attached to J N Medical College, Belgaum
Who cannot join
- Women with pregnancy induced hypertension
- antepartum haemorrhage
- previous caesarean section or presence of uterine scar
- diagnosed chorioamnionitis
- oxytocin induction or augmentation of labour
- intrauterine death
- diagnosed medical disorders (such as diabetes, cardiac, renal and hepatic diseases, etc.) or those in active labour (defined as >4 cm dilatation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A One Year Double Blind Randomized Controlled Trial of Sublingual Misoprostol (400 µg) Versus Intramuscular Oxytocin (10 IU) in the Prevention of Postpartum Bloodloss at KLE Hospital, Belgaum
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.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Misoprostol, Oxytocin
- Keywords
- Misoprostol, oxytocin, postpartum blood loss, hemoglobin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
400 µg sublingual misoprostol
OxytocinDrug
10 IU IM
| Study group | Role | What they receive |
|---|---|---|
| Sublingual misoprostol | Experimental | 400 µg powdered misoprostol administered sublingually; IM placebo Receives: Drug: Misoprostol |
| Oxytocin | Active comparator | 10 IU IM oxytocin; placebo powder Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 2 hours after delivery
Secondary outcomes (2)
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.
Measured: 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
Measured: 2 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startMar 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jawaharlal Nehru Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Cipla Ltd., AstraZeneca
- Investigators
- M B Bellad, M.D., Principal investigator, Jawaharlal Nehru Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373359
- Sponsor's protocol ID
- MDC/DOME/3707
- Status last verified
- Jan 2008
- First submitted
- 9 Jun 2011
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One Year Double Blind Randomized Controlled Trial of Sublingual Misoprostol (400 µg) Versus Intramuscular Oxytocin (10 IU) in the Prevention of Postpartum Bloodloss at KLE Hospital, Belgaum
- ClinicalTrials.gov ID
- NCT01373359
- Acronym / sponsor ID
- MDC/DOME/3707
- Conditions
- Postpartum Hemorrhage
- Keywords
- Misoprostol, oxytocin, postpartum blood loss, hemoglobin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- Jawaharlal Nehru Medical CollegeUniversity, hospital or other
- Collaborators
- Cipla Ltd., AstraZeneca
- Study start
- Mar 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 14 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual misoprostol | Experimental | Drug: Misoprostol400 µg powdered misoprostol administered sublingually; IM placebo |
| Oxytocin | Active comparator | Drug: Oxytocin10 IU IM oxytocin; placebo powder |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with a gestational age >28weeks
- singleton pregnancy with cephalic presentation anticipating a normal spontaneous vaginal delivery (including episiotomy)
- a haemoglobin ≥ 8g/dl upon presentation who were admitted to labour room in the KLE teaching hospital attached to J N Medical College, Belgaum
Key exclusion criteria (7 listed)
- Women with pregnancy induced hypertension
- antepartum haemorrhage
- previous caesarean section or presence of uterine scar
- diagnosed chorioamnionitis
- oxytocin induction or augmentation of labour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misoprostol400 µg sublingual misoprostol | Drug | Sublingual misoprostol |
| Oxytocin10 IU IM | Drug | Oxytocin |
Primary outcome
mean blood loss
Time frame: 2 hours after delivery
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).
postpartum hemorrhage (Blood loss >500 mls)
Time frame: 2 hours after delivery
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).
2 secondary outcomes
The percent of women experiencing a ≥10% postpartum decline in haemoglobin
Time frame: At presentation for delivery and 12-48 hours after delivery
Medication side effects
Time frame: 2 hours after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
Related trials for Postpartum Hemorrhage
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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M B Bellad, M.D. principal investigator
Jawaharlal Nehru Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Misoprostol and Oxytocin in people with Postpartum Hemorrhage, run by Jawaharlal Nehru Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean blood loss (time frame: 2 hours after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2011.