Retained PlacentaPhase 1NCT01840813
Intraumbilical Misoprostol in Retained Placenta
A Phase 1 study testing Misoprostol and Normal saline in people with Retained Placenta, run by Hawler Medical University at 1 site in Iraq.
Trial summary
Administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta and the amount of blood loss vaginally. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Retained Placenta
- What is being tested?
- Misoprostol and Normal saline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteIraq
- Study dates
- Apr 2011to Mar 2012
- Phase
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- women having singleton pregnancy
- 28 weeks of gestation or more delivered vaginally
- prolongation of the third stage of labour (more than 30 min) following active management of third stage of labour
Who cannot join
- Who refused to participate in the trial
- Multiple pregnancies
- Previous Caesarean Section
- Haemodynamically unstable
- Severe anaemia (haemoglobin less than 8gm/dl)
- Chorioamnionitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-umbilical Injection of Misoprostol Versus Normal Saline in the Management of Retained Placenta: Intrapartum Placebo-controlled Trial
Administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta and the amount of blood loss vaginally.
Read the detailed description
Retained placenta (RP)is one of the complications of third stage of labour; it should be managed promptly as it may cause severe bleeding, infection, maternal morbidity and mortality .The current standard management of RP word wide, by manual removal aims to prevent these problems, but it is unsatisfactory method because it requires general anaesthesia in hospital, It is an invasive procedure with its own serious complications of bleeding, infection and genital tract injury. Umbilical vein injection of misoprostol is a simple, safe method and could be performed at the place of delivery .
- Conditions
- Retained Placenta
- Being tested
- Misoprostol, Normal saline
- Keywords
- Intraumbilical misoprostol, Retained placenta, Active management of third stage of labour
- Medical subject headings
- Placenta, Retained
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called (Misotac)® tablet
It is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance.
Normal salineDrug
Also called Normal saline 0.9%
It is a placebo group
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Active comparator | 4 misoprostol tablets (Misotac® 200 micrograms tablet) dissolved in 20 ml of normal saline injected to umbilical vein Receives: Drug: Misoprostol |
| Normal saline | Placebo comparator | Normal saline 0.9%, 20 ml was injected in the umbilical vein in cases of retained placenta Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
delivery of placenta by medical intervention
The administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta under general anaesthesia.
Measured: 30 minutes after the injection of misoprostol or normal saline in the umbilical vein
Secondary outcomes (1)
vaginal bleeding after misoprostol use
using intraumbilical misoprostol in women with retained placenta reduces the amount of blood loss vaginally.
Measured: 30 minutes after umbilical vein injection of misoprostol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retained PlacentaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assistant Prof. Shahla Alalaf, Hawler Medical University
- Investigators
- Shahla K. Alalaf, Clinical M.D, Principal investigator, Hawler Medical UniversitySheelan S Rajab, High Diploma, Study chair, , Shaheed Dr.Khalid General Hospital, Directorate of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840813
- Sponsor's protocol ID
- HMU911
- Status last verified
- Nov 2013
- First submitted
- 18 Apr 2013
- Last updated
- 5 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-umbilical Injection of Misoprostol Versus Normal Saline in the Management of Retained Placenta: Intrapartum Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01840813
- Acronym / sponsor ID
- HMU911
- Conditions
- Retained Placenta
- Keywords
- Intraumbilical misoprostol, Retained placenta, Active management of third stage of labour
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Apr 2013 (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.
Administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta and the amount of blood loss vaginally.
Detailed description
Retained placenta (RP)is one of the complications of third stage of labour; it should be managed promptly as it may cause severe bleeding, infection, maternal morbidity and mortality .The current standard management of RP word wide, by manual removal aims to prevent these problems, but it is unsatisfactory method because it requires general anaesthesia in hospital, It is an invasive procedure with its own serious complications of bleeding, infection and genital tract injury. Umbilical vein injection of misoprostol is a simple, safe method and could be performed at the place of delivery .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Active comparator | Drug: Misoprostol4 misoprostol tablets (Misotac® 200 micrograms tablet) dissolved in 20 ml of normal saline injected to umbilical vein |
| Normal saline | Placebo comparator | Drug: Normal salineNormal saline 0.9%, 20 ml was injected in the umbilical vein in cases of retained placenta |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- women having singleton pregnancy
- 28 weeks of gestation or more delivered vaginally
- prolongation of the third stage of labour (more than 30 min) following active management of third stage of labour
Key exclusion criteria (6 listed)
- Who refused to participate in the trial
- Multiple pregnancies
- Previous Caesarean Section
- Haemodynamically unstable
- Severe anaemia (haemoglobin less than 8gm/dl)
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: (Misotac)® tabletIt is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance. | Drug | Misoprostol |
| Normal salineAlso: Normal saline 0.9%It is a placebo group | Drug | Normal saline |
Primary outcome
delivery of placenta by medical intervention
Time frame: 30 minutes after the injection of misoprostol or normal saline in the umbilical vein
The administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta under general anaesthesia.
1 secondary outcome
vaginal bleeding after misoprostol use
Time frame: 30 minutes after umbilical vein injection of misoprostol
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 5 Nov 2013.
Related trials for Retained Placenta
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Recruiting
Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
Retained Products of Conception
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, Clinical M.D principal investigator
Hawler Medical University
Sheelan S Rajab, High Diploma study chair
, Shaheed Dr.Khalid General Hospital, Directorate of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Misoprostol and Normal saline in people with 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 3 inclusion and 6 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 5 Nov 2013. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 by medical intervention (time frame: 30 minutes after the injection of misoprostol or normal saline in the umbilical vein). 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 5 Nov 2013.