Primary Postpartum HaemorrhageEarly Phase 1NCT02424201
Comparative Study on the Effects of Sublingual Misoprostol in Addition to Standard AMTSL in Low Risk Parturients in LASUTH, Ikeja.
A Early Phase 1 study testing Misoprostol and vitamin c in people with Primary Postpartum Haemorrhage, run by Lagos State University.
Trial summary
Postpartum haemorrhage is the leading cause of maternal haemorrhage globally. With active management of labour 3 to 16.5% of parturients still experience postpartum haemorrhage. Hence the need for an effective oxytocic in third stage of labour. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Postpartum Haemorrhage
- What is being tested?
- Misoprostol and vitamin c
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Feb 2016
- Phase
- Early Phase 1
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- singleton in longitudinal lie and cephalic presentation
Who cannot join
- refusal of consents, multiple gestation
About this study
Official title: Comparative Study on Effects of Sublingual Misoprostol in Addition to Standard Active Management of Third Stage of Labour in Low Risk Parturients in Lagos State University Teaching Hospital, Ikeja.
Postpartum haemorrhage is the leading cause of maternal haemorrhage globally. With active management of labour 3 to 16.5% of parturients still experience postpartum haemorrhage. Hence the need for an effective oxytocic in third stage of labour.
Read the detailed description
This is a prospective randomized doubleblind controlled trial involving 660 consenting pregnant women. Eligible subjects will be ransomised into 2 groups of 330 participants. All patients will receive the standard oxytocin 10 units as part of the active management of third stage of labour. However, the study group will be administered sublingual 400 misoprostol while the control group will receive 2tablets of placebo (vitamin c). Measured mean blood loss will be comparee in the 2 groups using statistical analysis.
- Conditions
- Primary Postpartum Haemorrhage
- Being tested
- Misoprostol, vitamin c
- Keywords
- uterine atony
- Medical subject headings
- Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
experimental
vitamin cDrug
Also called ascorbic acid
control
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | Intramuscular oxytocin 10 units, 400 micrograms of misoprostol Receives: Drug: Misoprostol |
| control | Other | Intramuscular oxytocin 10 units, 2 tablets of placebo which will be vitamin c Receives: Drug: vitamin c |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean blood loss
Measured: 1 hour of delivery
Secondary outcomes (1)
number of participants with untowards effects
Measured: 1 hour of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
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 Primary Postpartum HaemorrhageStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lagos State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oyedeko Muyideen Oladipo, Lagos State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424201
- Sponsor's protocol ID
- LagosSU
- Status last verified
- Apr 2015
- First submitted
- 18 Apr 2015
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ottun TA, Adewunmi AA, Rabiu AK, Olumodeji AM, Oladipo OM, Olalere HF. Misoprostol and oxytocin versus oxytocin alone in the active management of the third stage of labour: a randomised, double-blind, placebo-controlled trial. J Obstet Gynaecol. 2022 Jul;42(5):1048-1053. doi: 10.1080/01443615.2021.1995342. Epub 2021 Dec 27.
PubMed 34958620
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on Effects of Sublingual Misoprostol in Addition to Standard Active Management of Third Stage of Labour in Low Risk Parturients in Lagos State University Teaching Hospital, Ikeja.
- ClinicalTrials.gov ID
- NCT02424201
- Acronym / sponsor ID
- LagosSU
- Conditions
- Primary Postpartum Haemorrhage
- Keywords
- uterine atony
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Lagos State UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 22 Apr 2015 (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.
Postpartum haemorrhage is the leading cause of maternal haemorrhage globally. With active management of labour 3 to 16.5% of parturients still experience postpartum haemorrhage. Hence the need for an effective oxytocic in third stage of labour.
Detailed description
This is a prospective randomized doubleblind controlled trial involving 660 consenting pregnant women. Eligible subjects will be ransomised into 2 groups of 330 participants. All patients will receive the standard oxytocin 10 units as part of the active management of third stage of labour. However, the study group will be administered sublingual 400 misoprostol while the control group will receive 2tablets of placebo (vitamin c). Measured mean blood loss will be comparee in the 2 groups using statistical analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Drug: MisoprostolIntramuscular oxytocin 10 units, 400 micrograms of misoprostol |
| control | Other | Drug: vitamin cIntramuscular oxytocin 10 units, 2 tablets of placebo which will be vitamin c |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- singleton in longitudinal lie and cephalic presentation
Key exclusion criteria (1 listed)
- refusal of consents, multiple gestation
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: Cytotecexperimental | Drug | study |
| vitamin cAlso: ascorbic acidcontrol | Drug | control |
Primary outcome
mean blood loss
Time frame: 1 hour of delivery
1 secondary outcome
number of participants with untowards effects
Time frame: 1 hour of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Derived from this study: PubMed 34958620Ottun TA, Adewunmi AA, Rabiu AK, Olumodeji AM, Oladipo OM, Olalere HF. Misoprostol and oxytocin versus oxytocin alone in the active management of the third stage of labour: a randomised, double-blind, placebo-controlled trial. J Obstet Gynaecol. 2022 Jul;42(5):1048-1053. doi: 10.1080/01443615.2021.1995342. Epub 2021 Dec 27.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Misoprostol and vitamin c in people with Primary Postpartum Haemorrhage, run by Lagos State University.
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: status not confirmed, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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: 1 hour of delivery). 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 NCT02424201, 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 30 Apr 2015.