Postpartum HaemorrhagePhase 2NCT02704780
Two Different Regimens of Misoprostol in Retained Placenta
A Phase 2 study testing Misoprostol in people with Postpartum Haemorrhage and Retained Placenta, run by Hawler Medical University at 1 site in Iraq.
Trial summary
This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for the treatment of retained placenta to reduce the need of manual removal of placenta under general anaesthesia 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
- Postpartum Haemorrhage, Retained Placenta
- What is being tested?
- Misoprostol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 509 participants
- Where
- 1 siteIraq
- Study dates
- Mar 2016to 14 Feb 2019
- Phase
- Phase 2
- 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
- women with a singleton pregnancy, delivered vaginally
- 28 weeks of gestation and more,
- had a prolonged third stage of labor (more than 30 minutes) despite active management,
- Haemodynamically stable and accept to participate in the trial
Who cannot join
- multiple pregnancies,
- previous caesarean delivery,
- haemodynamically instability, severe anaemia (haemoglobin concentration <8 g/dL),
- chorioamnionitis
- Refused to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Umbilical Vein Injection of 800µg Misoprostol Versus 400 µg Misoprostol in the Treatment of Retained Placenta: A Multicenter, Randomized Double Blind Controlled Trial
This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for the treatment of retained placenta to reduce the need of manual removal of placenta under general anaesthesia
Read the detailed description
The third stage of labor may be complicated by retained placenta, which may cause severe bleeding and infection, with a potentially fatal outcome. Manual removal of placenta is the current standard of management of retained placenta which usually requires general or regional anaesthesia at a hospital and it is an invasive procedure that may lead to bleeding, trauma and infection. Intraumbilical injection of uterotonic agent( misoprostol) is an easy, non invasive procedure. A randomized clinical trial are required to determine the difference between two doses of misoprostol 400 versus 800 micro gram for management of retained placenta
- Conditions
- Postpartum Haemorrhage, Retained Placenta
- Being tested
- Misoprostol
- Keywords
- Retained placenta, Misoprostol, double blind, Randomization, Haemorrhage
- Medical subject headings
- Postpartum Hemorrhage, Placenta, Retained, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotic
2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women
| Study group | Role | What they receive |
|---|---|---|
| 400 Microgram Misoprostol | Active comparator | Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group Receives: Drug: Misoprostol |
| 800 Microgram Misoprostol | Active comparator | Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol
complete delivery of placenta after injection of intraumbilical misoprostol
Measured: up to 30 minutes after intraumbilical injection
Secondary outcomes (3)
The amount of blood loss vaginally in both groups
To estimate the amount of vaginal blood loss from time of injection of the the interventional drug and till the delivery of the placenta
Measured: up to 30 minutes after injection of placenta
The time of delivery of placenta in both groups
the time interval estimation from the injection to complete delivery of the placenta
Measured: up to 30 minutes after delivery of the placenta
side effects of misoprostol
Any side effects related to misoprostol after the injection (Fever, severing , diarrhea)
Measured: up to 24 hours after delivery of placenta
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion1 Feb 2019
- Study completion14 Feb 2019
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 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahla Alalaf, Hawler Medical University
- Investigators
- Shahla K. Alalaf, professor, Principal investigator, Hawler Medical UniversityNamir G. Al Tawil, Professor, Study director, Hawler Medical UniversityAriana Kh. Jawad, Assistant professor, Study chair, KBMSBahar Q. Muhammad, CABOG, Study chair, Maternity Teaching HospitalJinan N. Hassan, IBMS, Study chair, Duhok universitySalim A. Salim, Master, Study chair, Al-Azhar UniversityKhalida M. Ameen, CABOG, Study chair, Karkuk Medical collegeMaryam B. Mahmood, FICOG, Study chair, Sulaimani Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704780
- Sponsor's protocol ID
- HawlerMU
- Status last verified
- Feb 2019
- First submitted
- 19 Feb 2016
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kumar N, Jahanfar S, Haas DM, Weeks AD. Umbilical vein injection for management of retained placenta. Cochrane Database Syst Rev. 2021 Mar 11;3(3):CD001337. doi: 10.1002/14651858.CD001337.pub3.
PubMed 33705565
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Vein Injection of 800µg Misoprostol Versus 400 µg Misoprostol in the Treatment of Retained Placenta: A Multicenter, Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT02704780
- Acronym / sponsor ID
- HawlerMU
- Conditions
- Postpartum Haemorrhage, Retained Placenta
- Keywords
- Retained placenta, Misoprostol, double blind, Randomization, Haemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 10 Mar 2016 (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 study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for the treatment of retained placenta to reduce the need of manual removal of placenta under general anaesthesia
Detailed description
The third stage of labor may be complicated by retained placenta, which may cause severe bleeding and infection, with a potentially fatal outcome. Manual removal of placenta is the current standard of management of retained placenta which usually requires general or regional anaesthesia at a hospital and it is an invasive procedure that may lead to bleeding, trauma and infection. Intraumbilical injection of uterotonic agent( misoprostol) is an easy, non invasive procedure. A randomized clinical trial are required to determine the difference between two doses of misoprostol 400 versus 800 micro gram for management of retained placenta
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 400 Microgram Misoprostol | Active comparator | Drug: MisoprostolMisoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group |
| 800 Microgram Misoprostol | Active comparator | Drug: MisoprostolMisoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- women with a singleton pregnancy, delivered vaginally
- 28 weeks of gestation and more,
- had a prolonged third stage of labor (more than 30 minutes) despite active management,
- Haemodynamically stable and accept to participate in the trial
Key exclusion criteria (5 listed)
- multiple pregnancies,
- previous caesarean delivery,
- haemodynamically instability, severe anaemia (haemoglobin concentration <8 g/dL),
- chorioamnionitis
- Refused to participate in the trial
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: Cytotic2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women | Drug | 400 Microgram Misoprostol, 800 Microgram Misoprostol |
Primary outcome
Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol
Time frame: up to 30 minutes after intraumbilical injection
complete delivery of placenta after injection of intraumbilical misoprostol
3 secondary outcomes
The amount of blood loss vaginally in both groups
Time frame: up to 30 minutes after injection of placenta
The time of delivery of placenta in both groups
Time frame: up to 30 minutes after delivery of the placenta
side effects of misoprostol
Time frame: up to 24 hours after delivery of placenta
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 22 Feb 2019.
- Derived from this study: PubMed 33705565Kumar N, Jahanfar S, Haas DM, Weeks AD. Umbilical vein injection for management of retained placenta. Cochrane Database Syst Rev. 2021 Mar 11;3(3):CD001337. doi: 10.1002/14651858.CD001337.pub3.
- Individual participant dataSharing planned: No
Related trials for Postpartum Haemorrhage
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Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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.
Shahla K. Alalaf, professor principal investigator
Hawler Medical University
Namir G. Al Tawil, Professor study director
Hawler Medical University
Ariana Kh. Jawad, Assistant professor study chair
KBMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Misoprostol in people with Postpartum Haemorrhage and Retained Placenta, run by Hawler Medical University at 1 site in Iraq.
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 4 inclusion and 5 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 22 Feb 2019. 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 Iraq. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol (time frame: up to 30 minutes after intraumbilical injection). 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 NCT02704780, 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 22 Feb 2019.