Post Partum Haemorrhage in Patients Undergoing Cesarean SectionPhase 1/2NCT01572805
Evaluation of Melatonin's Effect on Pain and Blood Loss After Cesarean Section
A Phase 1/2 study testing melatonin 3mg and melatonin 6mg in people with Post Partum Haemorrhage in Patients Undergoing Cesarean Section, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to assess the effect of melatonin on pain and amount of blood loss after cesarean delivery one hundred twenty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Post Partum Haemorrhage in Patients Undergoing Cesarean Section
- What is being tested?
- melatonin 3mg and melatonin 6mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- Feb 2012to Oct 2012
- Phase
- Phase 1/2
- 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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women at term (37-40 wks) gestation scheduled for either elective or emergency lower segment cesarean section
Who cannot join
- women with any risk factor associated with an increased risk of postpartum hemorrhage were excluded i.e. multiple gestation, antepartum hemorrhage,poly-hydramnios, two or more previous cesarean sections and/or a history of previous rupture uterus
- current or previous history of significant disease including heart disease, liver, renal disorders ,anemia (Hb8 g%)or known coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the effect of melatonin on pain and amount of blood loss after cesarean delivery one hundred twenty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly allocated to one of three groups of 40 each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal of anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated Ringer's solution) at the rate of 500 ml over a 15 minutes period, immediately after delivery of the neonate was infused . Time to first requirement of analgesic supplement, Hemodynamic variables,will be recorded.Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given. For determination of blood loss ,change in hemoglobin levels, need for additional oxytocics and ,the volume of blood in the suction bottle was measured, blood soaked sponges. Hemoglobin values were determined both before surgery and 12 h following surgery
- Being tested
- melatonin 3mg, melatonin 6mg, placebo
- Keywords
- Post partum haemorrhage, Cesarean, Pain
- Medical subject headings
- Postpartum Hemorrhage, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatonin 3mgDrug
To receive sublingual 3 mg melatonin before spinal of anesthesia .
melatonin 6mgDrug
To receive sublingual 6 mg melatonin before spinal of anesthesia .
placeboDrug
To receive sublingual placebo tablet before spinal of anesthesia .
| Study group | Role | What they receive |
|---|---|---|
| melatonin 3mg | Active comparator | Not described Receives: Drug: melatonin 3mg |
| melatonin 6mg | Active comparator | Not described Receives: Drug: melatonin 6mg |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first requirement of analgesic supplement
Measured: Time to first requirement of analgesic supplement within 24 hours after intratechal injection
amount of blood loss after cesarean delivery
Measured: during surgery
Secondary outcomes (1)
hemodynamic variables
Measured: 5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 min after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionOct 2012
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 Post Partum Haemorrhage in Patients Undergoing Cesarean SectionStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marzieh beigom khezri, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572805
- Sponsor's protocol ID
- ACTRN12612000117819
- Status last verified
- Oct 2012
- First submitted
- 3 Apr 2012
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khezri MB, Reihany MD, Dabbaghi Ghaleh T, Mohammadi N. Effect of Melatonin on Blood Loss After Cesarean Section: A Prospective Randomized Double-Blind Trial. J Obstet Gynaecol India. 2019 Oct;69(5):436-443. doi: 10.1007/s13224-019-01205-7. Epub 2019 Apr 24.
PubMed 31598047
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Melatonin's Effect on Pain and Blood Loss After Cesarean Section
- ClinicalTrials.gov ID
- NCT01572805
- Acronym / sponsor ID
- ACTRN12612000117819
- Keywords
- Post partum haemorrhage, Cesarean, Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Apr 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.
The purpose of this study is to assess the effect of melatonin on pain and amount of blood loss after cesarean delivery one hundred twenty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly allocated to one of three groups of 40 each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal of anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated Ringer's solution) at the rate of 500 ml over a 15 minutes period, immediately after delivery of the neonate was infused . Time to first requirement of analgesic supplement, Hemodynamic variables,will be recorded.Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given. For determination of blood loss ,change in hemoglobin levels, need for additional oxytocics and ,the volume of blood in the suction bottle was measured, blood soaked sponges. Hemoglobin values were determined both before surgery and 12 h following surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| melatonin 3mg | Active comparator | Drug: melatonin 3mg |
| melatonin 6mg | Active comparator | Drug: melatonin 6mg |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant women at term (37-40 wks) gestation scheduled for either elective or emergency lower segment cesarean section
Key exclusion criteria (2 listed)
- women with any risk factor associated with an increased risk of postpartum hemorrhage were excluded i.e. multiple gestation, antepartum hemorrhage,poly-hydramnios, two or more previous cesarean sections and/or a history of previous rupture uterus
- current or previous history of significant disease including heart disease, liver, renal disorders ,anemia (Hb8 g%)or known coagulopathy
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 |
|---|---|---|
| melatonin 3mgTo receive sublingual 3 mg melatonin before spinal of anesthesia . | Drug | melatonin 3mg |
| melatonin 6mgTo receive sublingual 6 mg melatonin before spinal of anesthesia . | Drug | melatonin 6mg |
| placeboTo receive sublingual placebo tablet before spinal of anesthesia . | Drug | placebo |
Primary outcome
Time to first requirement of analgesic supplement
Time frame: Time to first requirement of analgesic supplement within 24 hours after intratechal injection
amount of blood loss after cesarean delivery
Time frame: during surgery
1 secondary outcome
hemodynamic variables
Time frame: 5min before the intrathecal injection,and at 2, 4, 6, 10, 15,20 min after the injection
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 11 Oct 2012.
- Derived from this study: PubMed 31598047Khezri MB, Reihany MD, Dabbaghi Ghaleh T, Mohammadi N. Effect of Melatonin on Blood Loss After Cesarean Section: A Prospective Randomized Double-Blind Trial. J Obstet Gynaecol India. 2019 Oct;69(5):436-443. doi: 10.1007/s13224-019-01205-7. Epub 2019 Apr 24.
Related trials for Post Partum Haemorrhage in Patients Undergoing Cesarean Section
Not yet recruitingPhase 4
Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR)
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingPhase 3
Investigating the Efficacy of Tranexamic Acid as a Prophylactic Agent in Reducing Postpartum Hemorrhage Among Patients Undergoing Cesarean Section in SQUH
Post Partum Haemorrhage
Recruiting
Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Postpartum Hemorrhage (Primary)
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 Phase 1/2 study testing melatonin 3mg and melatonin 6mg in people with Post Partum Haemorrhage in Patients Undergoing Cesarean Section, run by Qazvin University Of Medical Sciences at 1 site in Iran.
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 2 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 11 Oct 2012. 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 Iran. 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 combined 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.
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?
Time to first requirement of analgesic supplement (time frame: Time to first requirement of analgesic supplement within 24 hours after intratechal injection). 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?
On the ClinicalTrials.gov record for NCT01572805, 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 11 Oct 2012.