Postpartum HemorrhageNCT01713153
Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal
A study testing Misoprostol and UnijectTM in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 1 site in Senegal.
Trial summary
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 Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Misoprostol and UnijectTM
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,365 participants
- Where
- 1 siteSenegal
- Study dates
- Jun 2012to Jan 2014
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- women delivering in community health centers (case de sante) with a trained study provider (matrone) who are able to provide informed consent
Who cannot join
- women with known contraindications to prostaglandins
Trial locations and contacts
1 site in 1 country.
Senegal1 site
Health huts in the district of Thiadiaye and Kolda
Thiadiay and Kolda, Thiadiaye and Kolda
About this study
Official title: Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin Uniject in Senegal
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
Read the detailed description
This study will assess the programmatic implications (including feasibility, acceptability, 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.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Misoprostol, UnijectTM
- Keywords
- postpartum hemorrhage, prevention, misoprostol, Uniject, oxytocin
- 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
Also called Cytotec, Misoclear
600 mcg misoprostol oral
UnijectTMDevice
10 IU oxytocin delivered intramuscularly with UnijectTM
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | 600 mcg oral misoprostol administered during the third stage of labor Receives: Drug: Misoprostol |
| UnijectTM | Experimental | 10 IU oxytocin delivered IM with UnijectTM during he third stage of labor Receives: Device: UnijectTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during 3rd trimester and 1-3 days postpartum
Secondary outcomes (6)
Occurrence and management of side effects
nausea, vomiting, diarrhea, shivering, fever
Measured: 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
Measured: collected immediately following birth, verified 1-3 days postpartum
change in hemoglobin ≥ 2 g/dL
Measured: during third trimester and 1-3 days postpartum
additional interventions
use of additional uterotonics, manual removal of placental fragments, etc
Measured: during birth
referrals
referral requested, transfers carried out, reasons for incomplete referrals/transfers
Measured: 0-3 days postpartum
acceptability
acceptability according to woman of study medication, care received, side effects experienced
Measured: 1-3 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- ChildFund International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713153
- Sponsor's protocol ID
- 2.4.9
- Status last verified
- Feb 2016
- First submitted
- 22 Oct 2012
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diop A, Daff B, Sow M, Blum J, Diagne M, Sloan NL, Winikoff B. Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial. Lancet Glob Health. 2016 Jan;4(1):e37-44. doi: 10.1016/S2214-109X(15)00219-3.
PubMed 26718808
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin Uniject in Senegal
- ClinicalTrials.gov ID
- NCT01713153
- Acronym / sponsor ID
- 2.4.9
- Conditions
- Postpartum Hemorrhage
- Keywords
- postpartum hemorrhage, prevention, misoprostol, Uniject, oxytocin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,365 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- ChildFund International
- Study start
- Jun 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Oct 2012 (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.
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
Detailed description
This study will assess the programmatic implications (including feasibility, acceptability, 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: Misoprostol600 mcg oral misoprostol administered during the third stage of labor |
| UnijectTM | Experimental | Device: UnijectTM10 IU oxytocin delivered IM with UnijectTM during he third stage of labor |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- women delivering in community health centers (case de sante) with a trained study provider (matrone) who are able to provide informed consent
Key exclusion criteria (1 listed)
- women with known contraindications to prostaglandins
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 |
|---|---|---|
| MisoprostolAlso: Cytotec, Misoclear600 mcg misoprostol oral | Drug | Misoprostol |
| UnijectTM10 IU oxytocin delivered intramuscularly with UnijectTM | Device | UnijectTM |
Primary outcome
Mean change in hemoglobin
Time frame: during 3rd trimester and 1-3 days postpartum
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
6 secondary outcomes
Occurrence and management of side effects
Time frame: 1 hour postpartum
correct timing of drug administration
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
Time frame: during birth
referrals
Time frame: 0-3 days postpartum
acceptability
Time frame: 1-3 days postpartum
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 25 Feb 2016.
- Derived from this study: PubMed 26718808Diop A, Daff B, Sow M, Blum J, Diagne M, Sloan NL, Winikoff B. Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial. Lancet Glob Health. 2016 Jan;4(1):e37-44. doi: 10.1016/S2214-109X(15)00219-3.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol and UnijectTM in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 1 site in Senegal.
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 1 inclusion and 1 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 25 Feb 2016. 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 Senegal. 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.
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 change in hemoglobin (time frame: during 3rd trimester and 1-3 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01713153, which also lists 1 linked publication.
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 25 Feb 2016.